Re: What is Nonylphenol 8 and Safety/Uses

[Guest guest]

>I was told my emulsifier was to be called " nonylphenol 8 " .

>Is this the INCI name, and is this really an emulsifier?

Nonylphenol 8 is not an INCI name. There is, however, a Nonoxynol-8

listed.

Nonoxynol-8 is the ethoxylated alkyl phenol.

>This is the same product that was told to be called a " surfactant "

>on my ingredient label. When I explained that need an INCI, for my

>concern and consern of others and the FDA, the reply was to try

> " nonylphenol 8 " .

Nonoxynol-8 would be classified as a surfarctant.

Nonoxynol-8 is sold under these trade names:

Alkasurf NP-8 (Rhodia)

Arkopal N-080 (Clariant GmbH Functional Chemicals)

T-DET N-8 (Harcros)

Empilan NP8 (Albright & UK)

Igepal CO-610 (Rhodia)

MAKON 8 (Stepan)

Nikkol NP-7.5 (Nikko)

Renex 688 (Uniqema Americas)

Sabofen AF 8 (Sabo)

Unicol NP-8 (Universal Preserv-A-Chem)

As far as safety is concern, I found these two CIR Expert Panel safety

reviews.

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Final report on the safety assessment of nonoxynols-2,-4,-8,-9,-10,

-12,-14,-15,-30,-40,and-50

J Am Coll Toxicol Vol:2, 7 (1983) pp 35-60

Abstract:

Nonoxynols are chemically stable ethoxylated alkylphenols which are

chemically foaming and solubilizing agents. Estimates of the acute oral

LD50s of nine of the nonoxynols (-2 to -15) range from 0.62 to 7.4 g/kg

in several animal species. Acute dermal toxicity studies in rabbits

produced an LD50 range of 1.8 ml/kg to 4.4 g/kg. Skin irritation tests

on rabbits indicated that nonoxynols are nonirritating to moderately

irritating. Nonoxynol compounds with short ethoxylated chains are

generally severe ocular irritant, whereas long-chained nonoxynols are

only slightly irritating to the rabbit eye. No evidence of

carcinogenicity was observed when nonoxynol-4 and -9 were fed to both

dogs and rats. A mutagenicity study of these two compounds by the Ames

test was negative. Undiluted nonoxynol-4 and -9 were nonirritating and

nonsensitizing in clinical studies. A 50% solution of nonoxynol-15

and/or nonoxynol-50 produced no irritation or sensitization when tested

on 168 subjects, nor was there evidence of phototoxicity when tested on

a subset of this population. It is concluded that nonoxynols-2,-

4,-8,-9,-10,-12,-14,-15,-30,-40, and -50 are safe as cosmetic

ingredients.

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Amended final report on the safety assessment of Nonoxynol -1, -2, -3,

-4, -5, -6, -7 and -8

Int J Toxicol Vol:18, Suppl 1 (1999) pp 11-31

Abstract:

Nonoxynol-1, -2, -3, 4, -5, -6, -7, and -8 are ethoxylated alkylphenols

that are used in cosmetic products as surfactants-emulsifying agents.

The product formulation data submitted to the Food and Drug

Administration (FDA) in 1996 indicated that, collectively, Nonoxynol-

1, -2, -4, -5, -6, and -7 were used in a total of 870 cosmetic

products. There were no reported uses of Nonoxynol-3 and -8 in 1996.

Concentration of use data are no longer reported to FDA by the

cosmetics industry. The following concentration of use data on

Nonoxynols in Clairol hair care and color products were submitted to

CIR in 1994: Nonoxynol-2 was used at concentrations ranging from 1 to

20% in approximately 140 hair coloring products containing either

oxidative or direct hair dyes. Nonoxynol-4 was used at concentrations

ranging from 2 to 10% in approximately 200 hair coloring products

containing either oxidative or direct dyes. Nonoxytiol-9 was used at

concentrations ranging from 1 to 20% in approximately 40 hair coloring

products containing oxidative dyes and hair care products. Data

submitted to CTFA in 1995 indicated that Nonoxynol-2 was used at

concen- trations of 1 to 20% (on head, 0.5 to 10%) and that Nonoxynol-4

was used at concentrations of 2 to 10% (on head, 1.05 to 5.0%). In in

vitro skin penetration studies using cadaver skin (rinseoff and

leave-on protocols), the total skin penetration of Nonoxynol-2, -4, and

-9 was less than 1 % over a period of 48 hours. In mice intravenously

injected with 14 C-Nonoxynol-9, the highest amounts of radioactivity

were reported for the small and large intestines. 14C radioactivity was

excreted mainly in the urine and feces. An HPLC analysis of the urine

and bile indicated that no intact Nonoxynol-9 was present in the bile

or urine, and that Nonoxynol-9 was metabolized to highly polar species.

Nonoxynol-5 and -6 were slightly toxic in acute oral toxicity studies

involving rats. In 90-day feeding studies involving rats and dogs,

there were no test substance-related deaths after the administration of

0.040, 0.20, or 1.0 g/kg/day doses of Nonoxynol-6. However, elevated

liver-to-body weight ratios were reported. In acute dermal toxicity

studies involving rabbits, LD50s for Nonoxynol-5 and -6 were not

achieved at doses of 2.0 and 3.0 g/kg, respectively. These chemicals

would be classified as slightly toxic, at most. Intraperitoneal

injections of Nonoxynol-9 (5 mg/100 g body weight) daily for 5 days

induced morphologic and biochemical changes in the liver of rats.

Intravaginal injections of this ingredient (5 mg/100g) daily for up to

20 days induced morphologic and biochemical changes in the liver and

biochemical changes in the kidneys of rats. In in vitro tests,

Nonoxynol-9 caused complete hemolysis of erythrocytes (from rabbits) at

concentrations of 0.006 to 0.12%, and was cytotoxic to rat liver cells

at concentrations of >10 ug/ml to 50 ug/ml. Daily intraperitoneal

injections (24 days) of 0.2% Nonoxynol-9 in sterile saline did not

induce immunotoxicity in female mice. Nonoxynol-6 induced severe ocular

irritation reactions in rabbits. Severe ocular irritation was also

observed in animals (species not stated) tested with Nonoxynol-5. Skin

irritation reactions were observed in rabbits patch-tested with

concentrations of 25 to 100% Nonoxytiol-6 in petrolatum. In another

study, Nonoxynol-6 was severely irritating to both abraded and intact

skin of rabbits. Nonoxynol-5 was also classified as a severe skin

irritant in animals (species not stated). Mucous membrane irritation

was observed in groups of rabbits dosed intravaginally with Nonoxynol-9

(2.5 to 50.0 ing) with concentrations ranging from 2.5 to 75.0%. In the

maximization test, Nonoxynol-6 (test concentrations up to 27%) was not

a sensitizer in guinea pigs. The nonirritant test concentration in a

pretest control group of guinea pigs was detem-iined to be 2.7%. The

intraperitoneal administration of Nonoxynol-9 at doses ranging from 20

to 60 mg/kg for 5 days did not cause an increase in the frequency of

morphologically abnormal sperm over that observed in the control group.

Intravaginal doses of Nonoxynol-9 (5 ing/100 g body weight) on

gestation days 3 and 7 caused significant differences in the number of

normal implantation sites and the number of resorption sites between

experimental and control groups. Nonoxynol- 10 (600 ing /kg/day) did

not induce developmental toxicity in female mice dosed orally on days 6

through 13 of gestation. Nonoxynol-9 was embryolethal and fetocidal,

but not teratogenic, when administered intravaginally (2.5 ing/100 g

body weight) to groups of pregnant rats on days 1 through 10 of

gestation. In another study, the no-effect level for Nonoxynol-9 in an

oral teratogenicity study was 50 mg/kg/day (gestation days 9 to 15);

doses up to 500 mg/kg/day were administered. Nonoxynol-30 induced

neither reproductive nor teratogenic effects on the skeleton and soft

tissues of female rats at doses of 50,250, and 1000 mg/kg/day. When

doses of 50 and 500 mg/kg/day Nonoxynol-9 (gestation days 6 to 15) were

administered dermally to female rats, no dose-related effects on

skeletal and soft tissues were observed; however, a significant

increase in extra ribs was observed only in the 50 mg/kg dose group. In

another study, it was concluded that Nonoxynol-9 (in a contraceptive

cream) was neither embryotoxic nor teratogenic when administered

intravaginally to female rats at doses up to 40 mg Nonoxynol/kg/day on

days 6 through 15 of gestation. The oral administration of a product

containing 14.0% nonylphenoxy polyethoxy ethanol (a Nonoxynol; number

of moles ethylene oxide not stated) on days 7 to 16 of gestation did

not result in any significant differences in fetal malformations

between experimental and control groups. Doses up to 50 mg/kg/day were

tested. Nonoxynol-9 was not mutagenic in the Ames test or unscheduled

DNA synthesis assay (adult rat hepatocytes), and did not induce

malignant transformations (in vitro) in rat liver T51B cells.

Nonoxynol-10 also was not mutagenic in the Ames test. Malignant

transformations (in vitro) were observed in mouse fibroblasts (BALB/3T3

and 10T1/2 cells) that were incubated with Nonoxynol-9; Nonoxynol-40

did not induce malignant transformations. Nonoxynol-9 was neither toxic

nor carcinogenic in a lifetime exposure study involving rats. The rats

were dosed intravaginally with 6.7 and 33.6 mg/kg Nonoxynol-9 three

times per week for a total of 24 months. Blood test results on samples

obtained from 10 women who received intravaginal applications of

Nonoxynol-9 daily for 14 consecutive days indicated no effects on

either hepatic function or hematologic parameters. The only significant

finding was a reduction in serum cholesterol. No evidence of

alterations in hepatic function, based on blood test results for 30

women who had received intravaginal applications of a cream containing

5.0% Nonoxynol-9 daily for 14 days was observed. Vaginal mucous

membrane irritation was observed in 6 of 14 women after insertion of a

suppository containing 150 mg Nonoxynol-9 (hourly for 4 consecutive

hours) for 14 consecutive days. The results of another study indicated

that frequent use of vaginal suppositories containing Nonoxynol-9 (150

mg) may result in increased epithelial disruption. Use frequencies in

the groups tested ranged from one suppository every other day for 2

weeks to four suppositories daily for 2 weeks. Nonoxynol-2 (5% in

mineral oil), Nonoxynol-2 (10% in mineral oil), and Nonoxynol-4 (10% in

mineral oil) were tested in three separate human repeated insult patch

tests (predictive), respectively, according to the same procedure.

There was no evidence of allergic contact dermatitis in any of the 102

subjects patch tested with 5% Nonoxynol-2 in mineral oil. Allergic

contact dermatitis was observed in 9 of 103 subjects patch tested with

10% Nonoxynol-2 in mineral oil and in 3 of 107 subjects patch tested

with 10% Nonoxynol-4 in mineral oil. Strong sensitization reactions

were observed in each of the 12 contact dermatitis patients patch

tested with a 2.0% aqueous solutions of Nonoxynol-8.3, -9, or -10. Ten

of the patients had used antiseptic pre

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Maurice

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Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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