Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
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: Referenced study in summarizing report with limited details on test conditions.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final report on the safety assessment of Cetyl Lactate and Myristyl Lactate.
Author:
Elder, R. L.
Year:
1982
Bibliographic source:
J. Am. Coll. Toxicol. 1:97-107
Reference Type:
other company data
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Thirty day skin irritation test.
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
25% solution of Cetyl Lactate in mineral oil.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Body weights: 2.0 to 3.0 kg

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: mineral oil
Duration of treatment / exposure:
For 30 days, the solution was applied each morning to the back of each animal, after which the animals were restrained in stocks for four hours.
Doses / concentrations
Dose / conc.:
500 mg/kg bw/day
Remarks:
Doses / Concentrations:
5 ml of a 25% solution corresponds with approx. 1250 mg. Considering an average body weight of 2.5 kg this corresponds with an estimated dose of 500 mg/kg bw.

No. of animals per sex per dose:
3

Examinations

Observations and examinations performed and frequency:
Blood counts were made at the beginning of the experiment, at the end of the second week, when the last application was made, and one week after the last application.
Sections of skin were removed from test application sites and fixed in formalin for histological examination.
Body weights and weight gain were recorded weekly.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Haematological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
Weight gains and blood counts were normal throughout the test period. No irritation as evidenced by erythema and edema was found following any of the applications. Scarified areas showed normal healing, and histological examination of the skin showed a normal picture. It was concluded that no irritation occurred upon daily application of a 25% solution of Cetyl Lactate for 30 days.

Effect levels

Key result
Dose descriptor:
NOEL
Effect level:
>= 500 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Dermal irritation, clinical signs, body weights, haematology and histopathology.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No irritation occurred upon daily application of a 25% solution of Cetyl Lactate for 30 days.