Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Review

Data source

Reference
Reference Type:
review article or handbook
Title:
Safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolate, methyl, ethyl, ptopyl, and butyl glycolate, and lactic acid, ammonium calcium, potassium, sodium, and TEA-lactate, methyl, ethyl, isopropyl, and butyl lactate, and
Author:
Andersen, F.A.
Year:
1997
Bibliographic source:
International Journal of Toxicology, Vol.17, Suppl.1.

Materials and methods

Principles of method if other than guideline:
The dermal toxIcity of a face cream contamIng 0.25% of 85% aq. Lactic Acid was evaluated using two groups of 15 female Sprague-Dawley rats (Avon Products, Inc., 1995b). The test group receIved daily applications of 8B6 mg/kg applied 5 days/week for 13 weeks to a shaved dorsal area of the back; the control group was untreated (The dose was determmed by applyIng a factor of 100 x to the average daily human use determined usIng 1 g/day.) Animals were observed daily, and blood and urine samples were collected dunng weeks 7 and 13 from randomly selected ammals.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Type of coverage:
other: cosmetic cream
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
daily, 5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
886 mg/kg bw
Basis:
nominal per unit body weight
No. of animals per sex per dose:
15 (female only)
Control animals:
yes, concurrent no treatment

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

Dose descriptor:
LOAEL
Effect level:
886 mg/kg bw/day

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No significant gross observations, with the exception of
minimal skin irritation. Absolute brain weight and
kidney-to-body weight ratios were increased for test
animals.
No lesions were observed at necropsy or at microscopic
examination.

Applicant's summary and conclusion

Conclusions:
Formulation (face cream containing 0.25% lactic acid) is
safe in terms of cumulative toxicity. Based upon the
exaggerated dose levels used in this study for skin care
products, dermal applicaton is not likely to produce adverse
effects under conditions of consumer use.
Executive summary:

All animals survived to study termination. No significant gross observations, with the exception of minimal skin irritation throughout the study, could be attributed to dosing. During week 7, the blood urea nitrogen value was significantly increased for test ammals as compared to controls; no other hematological effects were seen, and urinary parameters were normal. Absolute brain weight and kidney-to-body weight ratios were statistically significantly increased for the test animals. No lesions were observed at necropsy or at microscopic exammation. The investigators concluded this formulation is "safe in terms of cumulative toxicity" and that "based upon the exaggerated dose level used in this study for skin care products, dermal application is not likely to produce adverse effects under conditions of consumer use."