RE: Re: Formaldehyde, Sensitization responses for Steve

[Guest guest]

RESPONSES embedded below...

Sorry Steve, I've been very occupied with billable matters.

1. Regarding:

" Do you disagree with OSHA or ATSDR that it is a sensitizer and causes

sensitization?"

Response: I believe it is and can. But since they haven't defined it, it

is was I consider "sensitizer" and "sensitization" to be, not what they

might think they are. 'How' is another manner.

RESPONSE: I would say the same about their use of the undefined terms and agree that "How" is the important question.

2. Regarding:

"The 'spreading phenomenon' whereby chemical sensitization to one compound

leads to MCS has been recognized."

Response:

This is cross-reactivity, and "spreading" is a poor word choice to relate it

to the mechanistic action.

RESPONSE: "Spreading" is the term used in MCS circles. It is more than simple cross-reactivity. The receptor mechanism becomes increasingly inclusive of additional chemical compounds to the initial one to which sensitization occurs. The phenomenon may indicate that more, different receptors (haptens, ligands) have been created, similar to the initial receptor created, rather than the same receptor reacting with similar environmental compounds.

3. Regarding:

My Questions:

How does one determine fault then?

How does one deal with confounding factors?

And your response

"My objective is not to determine fault, just to assess the environmental

cause of illness and what to do about it. I never said it was easy to deal

with. It isn't."

Response:

If you do not address confounding factors, you cannot truly determine

'environmental cause of illness' and you are then in the same category as

CIHs that misuse exposure limits.

RESPONSE: The way I determine environmental cause of illness is by working closely with the sensitive individual, not just testing the air like a CIH. The hypersensitive individual reacts to what he or she reacts to, at the level that causes a reaction in that individual, and not to what the levels of chemicals in the environment found with testing by a CIH or anyone else dictate.

4. Regarding your question (that I responded to):

"Do you think it is a misuse of exposure guidelines to conclude that

exposure to levels much lower than those that cause an effect in

non-sensitized persons could not cause an effect in someone who is

sensitized?"

With Tony's original response:

Use of any limit without looking at the purpose, assumptions and limitations

in that fashion would be a misuse and unethical.

Using the data that was relied upon to derive that limit would be

appropriate and ethical.

And Your Retort:

"It would not be appropriate in determining the cause of hypersensitivy

symptoms."

Response:

I disagree, if you have sensitization testing (GP maximization, MLLNA,

etc.), and human use data, one can state that something is not the "cause of

hypersensitivy symptoms" with reasonable scientific certainty. Of course,

one needs to discuss confounding factors that were and were not considered.

RESPONSE: The only sensitization testing that is meaningful is to monitor whether an inflammatory reaction occurs after an individual is exposed to a specific chemical substance or environment. One can only state that something is not the cause of hypersensitivity symptoms when someone doesn't react to it after being exposed.

5. regarding:

"RESPONSE: AIHA does not issue any certifications and I've never seen a job

or credibility lost because someone wasn't a member.:

Response:

So your intent is to punish, not correct?

RESPONSE: Absolutely. My intent would be to punish a CIH who did not correct his or her unethical behavior. Some people do the right thing because it is the right thing to do. Some people only do the right thing if they fear being caught and punished for doing the wrong thing. If there is no enforcement of the CIH Code of Ethics (i.e., punishment) there will be no fear of being caught on the part of an unethical CIH and therefore no perceived reason to stop behaving unethically.

6. Regarding OSHA and ATSDR:

Neither has official definitions of sensitizer or sensitization that I am

aware of.

OSHA produced a DRAFT guidance document for HAZCOM. It stated (DRAFT):

"If an immunologic mechanism (allergy) is responsible for the tissue

reaction, the material will be

classified as a sensitizer rather than an irritant."

"The HCS definition for sensitizer is 'A chemical that causes a

substantial proportion of exposed people or animals to develop an

allergic reaction in normal tissue after repeated exposure to the

chemical.'

A sensitizer (allergen) causes little or no reaction in man or test

animals on first exposure. The problem arises on subsequent

exposures when a marked immunological response occurs. The

response is not necessarily limited to the contact site as it may be a

generalized body condition. Skin sensitization is common in

industry. Respiratory sensitization and generalized hyperallergy to

a few chemicals has also been known to occur. Well-known

examples of sensitizers are toluene diisocyanate, nickel

compounds, and poison ivy."

So OSHA doesn't really describe a) sensitizer very well, does not define

sensitization (the process), or c) a means to test or determine how to

classify a sensitizer.

6. As for Definitions:

Sensitization is a reaction to an agent resulting in a change in the immune

system (induction), which causes symptoms upon subsequent exposure to lower

concentrations (elicitation).

[Notes: These delayed hypersensitivity reactions can be manifested as

dermatitis and/or asthma. While some agents can cause both dermal and

respiratory sensitization, others appear to cause dermal sensitization only.

Elicitation is the disease state. Non-allergic reactions such as Reactive

Airways Dysfunction Syndrome (RADs) are not considered sensitization]

RESPONSE: Why is RADS not considered to be caused by allergic sensitization while other hypersensitivity reactions are? The answer is because it is not immune system mediated and cannot be confirmed with IgE or other immunoglobulin antibody testing. The inflammation is neurogenic in origin.

Since the subject of this post is "Formaldehyde, Sensitization...", let me refresh your photographic memory about the health effects associated with sensitization to formaldehyde:

From the CDC ATSDR....

"Chronic Exposure

The major concerns of repeated formaldehyde exposure are sensitization and cancer. In sensitized persons, formaldehyde can cause asthma and contact dermatitis. In persons who are not sensitized, prolonged inhalation of formaldehyde at low levels is unlikely to result in chronic pulmonary injury. Adverse effects on the central nervous system such as increased prevalence of headache, depression, mood changes, insomnia, irritability, attention deficit, and impairment of dexterity, memory, and equilibrium have been reported to result from long-term exposure. Chronic exposure may be more serious for children because of their potential longer latency period."

http://www.atsdr.cdc.gov/mhmi/mmg111.html#bookmark02

These adverse effects are not allergic effects but neurologic effects consistent with neurogenic inflammation. To educate folks about neurogenic inflammation, here is a link to an article titled, "Neurogenic Inflammation and Sensitivity to Environmental Chemicals":

http://ehp.niehs.nih.gov/members/1993/101-3/meggs-full.html

Abstract

"Neurogenic inflammation as a pathway distinct from antigen-driven, immune-mediated inflammation may play a pivotal role in understanding a broad class of environmental health problems resulting from chemical exposures. Recent progress in understanding the mediators, triggers, and regulation of neurogenic inflammation is reviewed. Evidence for and speculations about a role for neurogenic inflammation in established disorders such as asthma, rhinitis, contact dermatitis, migraine headache, and rheumatoid arthritis are presented. The sick building syndrome and multiple chemical sensitivity syndrome have been defined as clinical entities in which exposure to chemical inhalants gives rise to disease. Current data on the existence of chemical irritant receptors in the airway and skin are discussed ; neurogenic inflammation arising from stimulation of chemical irritant receptors is a possible model to explain many of the aspects of chemical sensitivities."

A Sensitizer is an agent that has substantial scientific data to support

confirmation in terms of both animal and human data by weight of evidence.

Weight of evidence from (W2005):

Human evidence

- clinical findings and test results including clinical history and data

from pulmonary function testing

- in vivo immunological tests (Human Repeat Insult Patch Test - HRIPT)

- in vitro immunological tests (serological analysis)

- a chemical structure related to known respiratory allergens (i.e.,

Structure Activity Relationship or SAR)

- positive data from controlled experimental studies

- multiple case reports of allergic contact dermatitis

Animal Evidence

- guinea pig maximization test

- Büehler test

- positive results in the mouse ear swelling test (MEST)

- a chemical structure related to that of known dermal allergens (i.e., SAR)

- Mouse Local Lymph Node Assay (MLLNA)

In watered-down terms, sensitization can be direct (if the molecule is large

enough) or indirect due to binding (agent to a molecule that is seen as a

hapten) or indirect post-reaction after exposure (irritation stimulating the

immune system).

Also, one could define Hypersensitivity as a process whereby reproducible

symptoms or signs, initiated by exposure to a defined stimulus (antigen) at

a dose tolerated by normal subjects (J2005).

"Formaldehyde is not a respiratory sensitizer, but can bring on the symptoms

of asthma in susceptible individuals, probably due to irritation of the

airways." (CCHOS2010) The evidence indicates fairly well that Formaldehyde

leads to sensitivity due to the irritation mode mentioned above. As such,

if one has "compliance with an exposure level based on avoidance of mucous

membrane irritation would preclude this concern."(B1985, B1995, H2010).

One should also note that there is a DOSE-RESPONSE curve for induction, and

a DOSE-RESPONSE curve for elicitation for both dermal and respiratory agents

[80 dermal and 43 respiratory agent tests including Formaldehyde and

Glutaraldehyde] (A2006). For sensitization, the curve gets shifted, but

it's still a DOSE-RESPONSE curve (P2002).

RESPONSE: The DOSE-RESPONSE curve is specific for the individual when sensitization is induced and specific for the individual when a response is elicited. If one is not exposed, there is no risk of induction of sensitization or elicitation. Once someone is sensitized, the amount of chemical exposure that can elicit a response can be "de minimis" just like the amount of peanut protein only needs to be minute to elicit a response in someone who is severely hypersensitive to peanuts.

I agree that there is a great deal of confusion and misunderstanding about the definitions of the terms "sensitizer" and "sensitization". Unfortunately, there is often exploitation of this confusion by scientific gamesmen to obfuscate the distinction between an allergic hypersensitivity, which implies immunoglobulin antibody receptor mechanisms, and a chemical irritant hypersensitivity, which involves a neurogenic inflammatory mechanism as described in the article I provided the link to above. The article also proposes immunologic and neurologic "cross-over" mechanisms.

Folks should be careful not to use the terms "allergy" or "allergic" when refering to a chemical hypersensitivity reaction if they will later be required to "prove allergy" which cannot be confirmed with allergic testing.

Steve Temes

Tony

.......................................................................

"Tony" Havics, CHMM, CIH, PE

pH2, LLC

5250 E US 36, Suite 830 Avon

IN 46123

www.ph2llc.com

off

fax

cell

[Guest guest]

FYI, I have been told by physicians that if asthma like reaction occurs, the workplace or home can be "proven" to be a source by testing patient's reaction before and after daily or nightly occupancy with a peak flow meter. Has anyone tried this?

-----Original Message-----From: iequality [mailto:iequality ]On Behalf Of AirwaysEnv@...Sent: Sunday, November 07, 2010 7:38 PMTo: iequality Subject: Re: Re: Formaldehyde, Sensitization responses for Steve

RESPONSES embedded below...

Sorry Steve, I've been very occupied with billable matters.1. Regarding:" Do you disagree with OSHA or ATSDR that it is a sensitizer and causessensitization?"Response: I believe it is and can. But since they haven't defined it, itis was I consider "sensitizer" and "sensitization" to be, not what theymight think they are. 'How' is another manner.RESPONSE: I would say the same about their use of the undefined terms and agree that "How" is the important question.

2. Regarding:"The 'spreading phenomenon' whereby chemical sensitization to one compoundleads to MCS has been recognized."Response:This is cross-reactivity, and "spreading" is a poor word choice to relate itto the mechanistic action.RESPONSE: "Spreading" is the term used in MCS circles. It is more than simple cross-reactivity. The receptor mechanism becomes increasingly inclusive of additional chemical compounds to the initial one to which sensitization occurs. The phenomenon may indicate that more, different receptors (haptens, ligands) have been created, similar to the initial receptor created, rather than the same receptor reacting with similar environmental compounds.

3. Regarding:My Questions:How does one determine fault then?How does one deal with confounding factors?And your response"My objective is not to determine fault, just to assess the environmentalcause of illness and what to do about it. I never said it was easy to dealwith. It isn't."Response:If you do not address confounding factors, you cannot truly determine'environmental cause of illness' and you are then in the same category asCIHs that misuse exposure limits.RESPONSE: The way I determine environmental cause of illness is by working closely with the sensitive individual, not just testing the air like a CIH. The hypersensitive individual reacts to what he or she reacts to, at the level that causes a reaction in that individual, and not to what the levels of chemicals in the environment found with testing by a CIH or anyone else dictate.

4. Regarding your question (that I responded to):"Do you think it is a misuse of exposure guidelines to conclude thatexposure to levels much lower than those that cause an effect innon-sensitized persons could not cause an effect in someone who issensitized?"With Tony's original response:Use of any limit without looking at the purpose, assumptions and limitationsin that fashion would be a misuse and unethical.Using the data that was relied upon to derive that limit would beappropriate and ethical.And Your Retort: "It would not be appropriate in determining the cause of hypersensitivysymptoms."Response:I disagree, if you have sensitization testing (GP maximization, MLLNA,etc.), and human use data, one can state that something is not the "cause ofhypersensitivy symptoms" with reasonable scientific certainty. Of course,one needs to discuss confounding factors that were and were not considered.RESPONSE: The only sensitization testing that is meaningful is to monitor whether an inflammatory reaction occurs after an individual is exposed to a specific chemical substance or environment. One can only state that something is not the cause of hypersensitivity symptoms when someone doesn't react to it after being exposed.

5. regarding:"RESPONSE: AIHA does not issue any certifications and I've never seen a jobor credibility lost because someone wasn't a member.:Response:So your intent is to punish, not correct?RESPONSE: Absolutely. My intent would be to punish a CIH who did not correct his or her unethical behavior. Some people do the right thing because it is the right thing to do. Some people only do the right thing if they fear being caught and punished for doing the wrong thing. If there is no enforcement of the CIH Code of Ethics (i.e., punishment) there will be no fear of being caught on the part of an unethical CIH and therefore no perceived reason to stop behaving unethically.

6. Regarding OSHA and ATSDR:Neither has official definitions of sensitizer or sensitization that I amaware of.OSHA produced a DRAFT guidance document for HAZCOM. It stated (DRAFT):"If an immunologic mechanism (allergy) is responsible for the tissuereaction, the material will beclassified as a sensitizer rather than an irritant.""The HCS definition for sensitizer is 'A chemical that causes asubstantial proportion of exposed people or animals to develop anallergic reaction in normal tissue after repeated exposure to thechemical.'A sensitizer (allergen) causes little or no reaction in man or testanimals on first exposure. The problem arises on subsequentexposures when a marked immunological response occurs. Theresponse is not necessarily limited to the contact site as it may be ageneralized body condition. Skin sensitization is common inindustry. Respiratory sensitization and generalized hyperallergy toa few chemicals has also been known to occur. Well-knownexamples of sensitizers are toluene diisocyanate, nickelcompounds, and poison ivy."So OSHA doesn't really describe a) sensitizer very well, does not definesensitization (the process), or c) a means to test or determine how toclassify a sensitizer.6. As for Definitions:Sensitization is a reaction to an agent resulting in a change in the immunesystem (induction), which causes symptoms upon subsequent exposure to lowerconcentrations (elicitation).[Notes: These delayed hypersensitivity reactions can be manifested asdermatitis and/or asthma. While some agents can cause both dermal andrespiratory sensitization, others appear to cause dermal sensitization only.Elicitation is the disease state. Non-allergic reactions such as ReactiveAirways Dysfunction Syndrome (RADs) are not considered sensitization]RESPONSE: Why is RADS not considered to be caused by allergic sensitization while other hypersensitivity reactions are? The answer is because it is not immune system mediated and cannot be confirmed with IgE or other immunoglobulin antibody testing. The inflammation is neurogenic in origin.Since the subject of this post is "Formaldehyde, Sensitization...", let me refresh your photographic memory about the health effects associated with sensitization to formaldehyde:From the CDC ATSDR...."Chronic ExposureThe major concerns of repeated formaldehyde exposure are sensitization and cancer. In sensitized persons, formaldehyde can cause asthma and contact dermatitis. In persons who are not sensitized, prolonged inhalation of formaldehyde at low levels is unlikely to result in chronic pulmonary injury. Adverse effects on the central nervous system such as increased prevalence of headache, depression, mood changes, insomnia, irritability, attention deficit, and impairment of dexterity, memory, and equilibrium have been reported to result from long-term exposure. Chronic exposure may be more serious for children because of their potential longer latency period." http://www.atsdr.cdc.gov/mhmi/mmg111.html#bookmark02These adverse effects are not allergic effects but neurologic effects consistent with neurogenic inflammation. To educate folks about neurogenic inflammation, here is a link to an article titled, "Neurogenic Inflammation and Sensitivity to Environmental Chemicals":http://ehp.niehs.nih.gov/members/1993/101-3/meggs-full.htmlAbstract"Neurogenic inflammation as a pathway distinct from antigen-driven, immune-mediated inflammation may play a pivotal role in understanding a broad class of environmental health problems resulting from chemical exposures. Recent progress in understanding the mediators, triggers, and regulation of neurogenic inflammation is reviewed. Evidence for and speculations about a role for neurogenic inflammation in established disorders such as asthma, rhinitis, contact dermatitis, migraine headache, and rheumatoid arthritis are presented. The sick building syndrome and multiple chemical sensitivity syndrome have been defined as clinical entities in which exposure to chemical inhalants gives rise to disease. Current data on the existence of chemical irritant receptors in the airway and skin are discussed ; neurogenic inflammation arising from stimulation of chemical irritant receptors is a possible model to explain many of the aspects of chemical sensitivities."

A Sensitizer is an agent that has substantial scientific data to supportconfirmation in terms of both animal and human data by weight of evidence.Weight of evidence from (W2005):Human evidence- clinical findings and test results including clinical history and datafrom pulmonary function testing- in vivo immunological tests (Human Repeat Insult Patch Test - HRIPT)- in vitro immunological tests (serological analysis)- a chemical structure related to known respiratory allergens (i.e.,Structure Activity Relationship or SAR)- positive data from controlled experimental studies- multiple case reports of allergic contact dermatitisAnimal Evidence- guinea pig maximization test- Büehler test- positive results in the mouse ear swelling test (MEST)- a chemical structure related to that of known dermal allergens (i.e., SAR)- Mouse Local Lymph Node Assay (MLLNA)In watered-down terms, sensitization can be direct (if the molecule is largeenough) or indirect due to binding (agent to a molecule that is seen as ahapten) or indirect post-reaction after exposure (irritation stimulating theimmune system).Also, one could define Hypersensitivity as a process whereby reproduciblesymptoms or signs, initiated by exposure to a defined stimulus (antigen) ata dose tolerated by normal subjects (J2005)."Formaldehyde is not a respiratory sensitizer, but can bring on the symptomsof asthma in susceptible individuals, probably due to irritation of theairways." (CCHOS2010) The evidence indicates fairly well that Formaldehydeleads to sensitivity due to the irritation mode mentioned above. As such,if one has "compliance with an exposure level based on avoidance of mucousmembrane irritation would preclude this concern."(B1985, B1995, H2010).One should also note that there is a DOSE-RESPONSE curve for induction, anda DOSE-RESPONSE curve for elicitation for both dermal and respiratory agents[80 dermal and 43 respiratory agent tests including Formaldehyde andGlutaraldehyde] (A2006). For sensitization, the curve gets shifted, butit's still a DOSE-RESPONSE curve (P2002).RESPONSE: The DOSE-RESPONSE curve is specific for the individual when sensitization is induced and specific for the individual when a response is elicited. If one is not exposed, there is no risk of induction of sensitization or elicitation. Once someone is sensitized, the amount of chemical exposure that can elicit a response can be "de minimis" just like the amount of peanut protein only needs to be minute to elicit a response in someone who is severely hypersensitive to peanuts.I agree that there is a great deal of confusion and misunderstanding about the definitions of the terms "sensitizer" and "sensitization". Unfortunately, there is often exploitation of this confusion by scientific gamesmen to obfuscate the distinction between an allergic hypersensitivity, which implies immunoglobulin antibody receptor mechanisms, and a chemical irritant hypersensitivity, which involves a neurogenic inflammatory mechanism as described in the article I provided the link to above. The article also proposes immunologic and neurologic "cross-over" mechanisms.Folks should be careful not to use the terms "allergy" or "allergic" when refering to a chemical hypersensitivity reaction if they will later be required to "prove allergy" which cannot be confirmed with allergic testing.Steve Temes

Tony...................................................................... "Tony" Havics, CHMM, CIH, PE pH2, LLC 5250 E US 36, Suite 830 AvonIN 46123 www.ph2llc.com(317) 718-7020 off fax cell

[Guest guest]

Hello Steve and Tony,

Very informative discussion.  Do mold particles generated during

mold remediation (various mixes of mold types found at typical jobs) meet your

definition of a sensitizer? Dermal and/or respiratory?

As a follow up – What is a good baseline employee test for

remediation workers to get to show their baseline, prior to working on mold

remediation projects?  Something that could be done every year or two with their

HAZWOPER medical physical?

Brad

Harr

Summit Environmental, Inc.

From:

iequality [mailto:iequality ] On Behalf Of

Havics

Sent: Friday, November 05, 2010 6:50 PM

To: iequality

Subject: Re: Formaldehyde, Sensitization responses for Steve

Sorry Steve, I've been very occupied with

billable matters.

1. Regarding:

" Do you disagree with OSHA or ATSDR that it is a sensitizer and causes

sensitization? "

Response: I believe it is and can. But since they haven't defined it, it

is was I consider " sensitizer " and " sensitization " to be,

not what they

might think they are. 'How' is another manner.

2. Regarding:

" The 'spreading phenomenon' whereby chemical sensitization to one compound

leads to MCS has been recognized. "

Response:

This is cross-reactivity, and " spreading " is a poor word choice to

relate it

to the mechanistic action.

3. Regarding:

My Questions:

How does one determine fault then?

How does one deal with confounding factors?

And your response

" My objective is not to determine fault, just to assess the environmental

cause of illness and what to do about it. I never said it was easy to deal

with. It isn't. "

Response:

If you do not address confounding factors, you cannot truly determine

'environmental cause of illness' and you are then in the same category as

CIHs that misuse exposure limits.

4. Regarding your question (that I responded to):

" Do you think it is a misuse of exposure guidelines to conclude that

exposure to levels much lower than those that cause an effect in

non-sensitized persons could not cause an effect in someone who is

sensitized? "

With Tony's original response:

Use of any limit without looking at the purpose, assumptions and limitations

in that fashion would be a misuse and unethical.

Using the data that was relied upon to derive that limit would be

appropriate and ethical.

And Your Retort:

" It would not be appropriate in determining the cause of hypersensitivy

symptoms. "

Response:

I disagree, if you have sensitization testing (GP maximization, MLLNA,

etc.), and human use data, one can state that something is not the " cause

of

hypersensitivy symptoms " with reasonable scientific certainty. Of course,

one needs to discuss confounding factors that were and were not considered.

5. regarding:

" RESPONSE: AIHA does not issue any certifications and I've never seen a

job

or credibility lost because someone wasn't a member.:

Response:

So your intent is to punish, not correct?

6. Regarding OSHA and ATSDR:

Neither has official definitions of sensitizer or sensitization that I am

aware of.

OSHA produced a DRAFT guidance document for HAZCOM. It stated (DRAFT):

" If an immunologic mechanism (allergy) is responsible for the tissue

reaction, the material will be

classified as a sensitizer rather than an irritant. "

" The HCS definition for sensitizer is 'A chemical that causes a

substantial proportion of exposed people or animals to develop an

allergic reaction in normal tissue after repeated exposure to the

chemical.'

A sensitizer (allergen) causes little or no reaction in man or test

animals on first exposure. The problem arises on subsequent

exposures when a marked immunological response occurs. The

response is not necessarily limited to the contact site as it may be a

generalized body condition. Skin sensitization is common in

industry. Respiratory sensitization and generalized hyperallergy to

a few chemicals has also been known to occur. Well-known

examples of sensitizers are toluene diisocyanate, nickel

compounds, and poison ivy. "

So OSHA doesn't really describe a) sensitizer very well, does not define

sensitization (the process), or c) a means to test or determine how to

classify a sensitizer.

6. As for Definitions:

Sensitization is a reaction to an agent resulting in a change in the immune

system (induction), which causes symptoms upon subsequent exposure to lower

concentrations (elicitation).

[Notes: These delayed hypersensitivity reactions can be manifested as

dermatitis and/or asthma. While some agents can cause both dermal and

respiratory sensitization, others appear to cause dermal sensitization only.

Elicitation is the disease state. Non-allergic reactions such as Reactive

Airways Dysfunction Syndrome (RADs) are not considered sensitization]

A Sensitizer is an agent that has substantial scientific data to support

confirmation in terms of both animal and human data by weight of evidence.

Weight of evidence from (W2005):

Human evidence

- clinical findings and test results including clinical history and data

from pulmonary function testing

- in vivo immunological tests (Human Repeat Insult Patch Test - HRIPT)

- in vitro immunological tests (serological analysis)

- a chemical structure related to known respiratory allergens (i.e.,

Structure Activity Relationship or SAR)

- positive data from controlled experimental studies

- multiple case reports of allergic contact dermatitis

Animal Evidence

- guinea pig maximization test

- Büehler test

- positive results in the mouse ear swelling test (MEST)

- a chemical structure related to that of known dermal allergens (i.e., SAR)

- Mouse Local Lymph Node Assay (MLLNA)

In watered-down terms, sensitization can be direct (if the molecule is large

enough) or indirect due to binding (agent to a molecule that is seen as a

hapten) or indirect post-reaction after exposure (irritation stimulating the

immune system).

Also, one could define Hypersensitivity as a process whereby reproducible

symptoms or signs, initiated by exposure to a defined stimulus (antigen) at

a dose tolerated by normal subjects (J2005).

" Formaldehyde is not a respiratory sensitizer, but can bring on the

symptoms

of asthma in susceptible individuals, probably due to irritation of the

airways. " (CCHOS2010) The evidence indicates fairly well that Formaldehyde

leads to sensitivity due to the irritation mode mentioned above. As such,

if one has " compliance with an exposure level based on avoidance of mucous

membrane irritation would preclude this concern. " (B1985, B1995, H2010).

One should also note that there is a DOSE-RESPONSE curve for induction, and

a DOSE-RESPONSE curve for elicitation for both dermal and respiratory agents

[80 dermal and 43 respiratory agent tests including Formaldehyde and

Glutaraldehyde] (A2006). For sensitization, the curve gets shifted, but

it's still a DOSE-RESPONSE curve (P2002).

Tony

.......................................................................

" Tony " Havics, CHMM, CIH, PE

pH2, LLC

5250 E US 36, Suite 830 Avon

IN 46123

www.ph2llc.com

off

fax

cell

90% of Risk Management is knowing where to place the decimal point...any

consultant can give you the other 10%(SM)

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