Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
International Program on Chemical Safety - IPCS - Toxicological evaluation of certain food additives
Author:
Croda IPCS WHO
Year:
1982
Bibliographic source:
Twenty sixth report of the Joint FAO/WHO Expert Comittee on Food Additives, Geneva, WHO Tech. Rep. Ser. No. 863, 1982
Report Date:
1982
Reference Type:
other company data
Title:
Unnamed
Year:
1947

Materials and methods

Principles of method if other than guideline:
intraperitoneal injection of test substance in 10 female rats
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sorbitan tristearate
- Analytical purity: 50 % aqueous emulsion form

Test animals

Species:
rat
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 125-175 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
10 mL/kg bw (50% aqueous emulsion form)
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 48 hours

Results and discussion

Mortality:
2/10 animals died during the first 48 hours after exposure
Clinical signs:
Surviving animals did not show any symptoms of toxicity.
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion