Acetic acid, 2-hydroxy-, ammonium salt (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The study results have been reported in a review and it was not possible to evaluate the original study.

Data source

Reference

Reference Type:

publication

Title:

Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolates, methyl, ethyl, propyl, and butyl glycolates, and lactic acid, ammonium, calcium, potassium, sodium and tea-lactates, methyl, ethyl, isopropyl, and

Author:

Cosmetic Ingredient Review

Year:

1998

Bibliographic source:

International Journal of Toxicology, 17(Suppl. 1):1-3.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Eytex assay

Principles of method if other than guideline:

The basis for Eytex assay is a specialized protein reagent whose conformation and hydration are altered when exposed to a chemical irritant. Protocols used were MPA (not defined), UMA (upright membrane assay), and RMA (rapid membrane assay). A direct comparison to the Draize scale was made to determine Ocular Safety Classifications and was expressed as an Eytex/Draize Equivalent (EDE) score

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Glycollic acid

EC Number:

201-180-5

EC Name:

Glycollic acid

Cas Number:

79-14-1

Molecular formula:

C2H4O3

IUPAC Name:

glycol acid

Constituent 2

Reference substance name:

2-hydroxyacetic acid

IUPAC Name:

2-hydroxyacetic acid

Constituent 3

Reference substance name:

Glycolic Acid

IUPAC Name:

Glycolic Acid

Test material form:

not specified

Details on test material:

Glycolic acid in various cosmetic formulations.

Results and discussion

Any other information on results incl. tables

Product type	Conc. (%)	pH	Protocol	Eyetex class	EDE	Conclusion
70% Aq.
Body lotion	2,86	3,8	UMA	Mild moderate	26,5	Mild-moderate-irritant
Face cream	5,71	5,35	RMA	Minimal	10,6	Minimal irritant
Lipline gel	7,04	3,9	UMA	Mild moderate	31	Mild-moderate irritant
Hand and body lotion	8,57	3,89	UMA	Mild moderate	31,5	Mild-moderate irritant
Body lotion	11,42	3,5	MPA	Moderate	24	Moderate-severe irritant
Body lotion			RMA	Severe	50,2	Moderate-severe irritant
Body lotion	11,42	3,5	MPA	Moderate	49,5	Moderate-severe irritant
Body lotion			RMA	Severe	54,1	Moderate-severe irritant
Body lotion	11,42	3,5	MPA	Moderate	51,9	Moderate-severe irritant
Body lotion			RMA	Severe	Not	Moderate-severe irritant
Face cream	11,42	3,75	RMA	Moderate severe	43,3	Moderate-severe irritant
Body lotion	11,42	3,78	MPA	Moderate	54	Moderate-severe irritant
Body lotion			RMA	Severe	47,3	Moderate-severe irritant
Face cream	11,42	5,5	RMA	Minimal mild	13,1	Minimal-mild irritant
Lipline gel	14,08	3,89	UMA	Moderate severe	46	Moderate-severe irritant
Body lotion	14,29	N/A (50% EtOH)	UMA	Moderate severe	49,6	Moderate-severe irritant
Body lotion	14,29	3,6	MPA	Moderate	51,2	Moderate-severe irritant
Body lotion			RMA	Severe	54	Moderate-severe irritant
Body lotion	14,29	3,65	MPA	Moderate	51,6	Moderate-severe irritant
Body lotion			RMA	Severe	54	Moderate-severe irritant
Body lotion	14,29	3,65	MPA	Moderate	54	Moderate-severe irritant
Body lotion			RMA	Severe	Not	Moderate-severe irritant
Lipline gel	14,29	3,77	MPA	Severe	51	Severe irritant
Lipline gel			RMA	Severe	Not	Severe irritant
Hand and body lotion	14,29	3,82	UMA	Moderate severe	51	Moderate-severe irritant
Lipline gel	14,29	4,01	MPA	Moderate	37,4	Moderate irritant
Lipline gel			RMA	Moderate	Not	Moderate irritant
99% pure
Face lotion	8,08	3,70-3,90	UMA	Moderate severe	48,5	Moderate-severe irritant

Applicant's summary and conclusion

Conclusions:

Glycolic acid, as tested in the above cosmetic formulations, resulted mainly "moderate-severe irritant".