Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
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 is cited by CIR, 2011. Decyl Glucoside and Other Alkyl Glucosides as Used in Cosemtics. Final Safety Assessment.

Data source

Reference
Reference Type:
secondary source
Title:
Ecology and Toxicology of Alkyl Polyglucosides
Author:
Willing A, Messinger H and Aulmann W
Year:
2004
Bibliographic source:
CIR, 2011. Decyl Glucoside and Other Alkyl Glucosides as Used in Cosemtics. Final Safety Assessment.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Deviations:
not specified
GLP compliance:
not specified

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Main experiment: 10 males and 10 females.
Control: 5 males and 5 females.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
250 mg/kg bw/day
Basis:
no data
Remarks:
Doses / Concentrations:
500 mg/kg bw/day
Basis:
no data
Remarks:
Doses / Concentrations:
1000 mg/kg bw/day
Basis:
no data
No. of animals per sex per dose:
Main experiment: 10 males and 10 females.
Control: 5 males and 5 females.
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
Animal were subjected to routine clinical observations. Their body weight and food and water consumption were recorded. Haematologicalm clinicochemical and ophtalmoscopic investigations were performedduring week 7 and 13. At the end of the treatment period, all the animals were subjected to general pathological examination and organ weight analizes. A wide range of tissues was fixed and examineted by microscope.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
2 mortalities.
Mortality:
mortality observed, treatment-related
Description (incidence):
2 mortalities.
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
no effects observed
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:
no effects observed
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
ulcers and oedema confined to the forestomach of the highest dose level.
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
slowly reversible, dose-related irritation and ulceration of the mucous membrane of the forestomach of animals in the highest dose group.
Histopathological findings: neoplastic:
not specified

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
other: NOAEC
Effect level:
2.5 other: %
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: irritation and ulcers in the forestomach

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Systemic toxicity was not observed in any group. The NOAEL for systemic toxicity was 1000 mg/kg bw/day. The NOEC for “local compatibility” (irritation and ulceration of the mucous membrane of the forestomach) was deduced as 2.5% active ingredient.
Executive summary:

Sprague-Dawley rats were dosed by gavage with 0, 250, 500 and 1000 mg/kg bw/day C12/16 APG for 90 days. An additional 5 male and 5 female control and high dose rats were used as a recovery group. There were two fatalities, neither of which was linked to the test material. No treatment-related changes in body weights, organ weights, or biochemistry or hematology parameters were observed. Absolute gonad weights were decreased in all test groups, but the decrease was not considered treatment related by the researchers because of a lack of a dose-response. A dose-dependent, slowly reversible, irritation and ulceration of the forestomach mucosa was observed in animals of the 0.5 and 1 g/kg bw groups. Systemic toxicity was not observed in any group. The NOAEL for systemic toxicity was 1000 mg/kg bw. The NOEC for “local compatibility” (irritation and ulceration of the mucous membrane of the forestomach) was deduced as 2.5% active ingredient.