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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Sorbitan tristearate
EC Number:
247-891-4
EC Name:
Sorbitan tristearate
Cas Number:
26658-19-5
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
(2R)-2-[(2R,3R,4S)-3,4-bis(octadecanoyloxy)oxolan-2-yl]-2-hydroxyethyl octadecanoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl octadecanoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-(octadecanoyloxy)oxolan-2-yl]ethyl (9Z)-octadec-9-enoate
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 or test system 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