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: Study cited by: CIR, 2011. Decyl Glucoside and Other Alkyl Glucosides as Used in Cosmetics. Final Safety Assessment.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not applicable
Principles of method if other than guideline:
Using non-occlusive applications, 2 mL of 0, 0.06, 0.18, or 0.54 g a.i./kg caprylyl/capryl glucoside (60% active) in distilled water (corresponding to concentrations of 0, 3, 9, and 27% a.i., respectively) were applied to the intact skin of the backs of 6 male rabbits/group.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male

Administration / exposure

Type of coverage:
other: non-occlusive
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
60 mg/kg bw/day
Basis:
nominal per unit area
Remarks:
Doses / Concentrations:
180 mg/kg bw/day
Basis:
nominal per unit area
Remarks:
Doses / Concentrations:
540 mg/kg bw/day
Basis:
nominal per unit area
No. of animals per sex per dose:
6 males per group

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
slight to moderate
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
decrease
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
not statistically significative decrease in testes weight
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
epithelial hyperplasia, hyperkeratosis, congestion, and eschar formation were observed in the skin of rabbits of the high dose group. No test article-related microscopic changes were observed in the testes or accessory sex glands at any dose.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
180 mg/kg bw/day
Based on:
act. ingr.
Sex:
male
Basis for effect level:
other: Decrease in body and testes weight, not statistically significative.
Dose descriptor:
LOAEL
Effect level:
60 mg/kg bw/day
Based on:
act. ingr.
Sex:
male
Basis for effect level:
other: Slight to moderate dermal irritation.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In the main study, treatment-related signs of toxicity were not observed. Slight dermal irritation was observed in all groups after the initiation of dosing; the irritation became moderate in the high dose group after 3 days of dosing. Microscopically, epithelial hyperplasia, hyperkeratosis, congestion, and eschar formation were observed in the skin of rabbits of the high dose group; these changes were not observed in rabbits of the other test groups. Body weights of rabbits of the high dose group were slightly, but significantly, decreased compared to controls. Absolute testes weights were slightly, but not significantly, decreased in the high dose group. Microscopically, no test article-related microscopic changes were observed in the testes or accessory sex glands at any dose. No treatment-related effects on hematology or clinical chemistry values or organ weights were reported. The NOEL for systemic toxicity was 0.18 g a.i./kg caprylyl/capryl glucoside.
Executive summary:

In a 14 -day study, using non-occlusive applications, 2 mL of 0, 60, 180, or 540 g active ingredient/kg caprylyl/capryl

glucoside (60% active) in distilled water were applied to the intact skin of the backs of 6 male rabbits/group. Slight dermal irritation was observed in all groups after the initiation of dosing; the irritation became moderate in the high dose group after 3 days of dosing. Microscopically, epithelial hyperplasia, hyperkeratosis, congestion, and eschar formation were observed in the skin of rabbits of the high dose group; these changes were not observed in rabbits of the other test groups. Body weights of rabbits of the high dose group were slightly, but significantly, decreased compared to controls. Absolute testes weights were slightly, but not significantly, decreased in the high dose group. Microscopically, no test article-related changes were observed in the testes or accessory sex glands at any dose.

No treatment-related effects on hematology or clinical chemistry values or organ weights were reported. The NOEL for systemic toxicity was 0.18 g a.i./kg caprylyl/capryl glucoside.