Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited documentation (analytical purity of test substance not specified, 7-day observation period).

Data source

Reference
Reference Type:
publication
Title:
The oral Toxicity and Pathology of Polyethoxyethylene Derivatives in Rats and Hamsters
Author:
Eagle, E. and Poling, C.E.
Year:
1956
Bibliographic source:
Food research 21: 348

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(analytical purity of test substance not specified, 7-day observation period)
Principles of method if other than guideline:
Acute oral toxicity test in rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan monolaurate, ethoxylated
EC Number:
500-018-3
EC Name:
Sorbitan monolaurate, ethoxylated
Cas Number:
9005-64-5
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)
Details on test material:
- Name of test material (as cited in study report): Polyoxyethylene-20-sorbitan monolaurate (PSML)
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150 - 220 g
- Fasting period before study: 18 h, but water ad libitum
- Housing: individually
- Water : ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25.6 - 27.8
- Humidity (%): 45

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
36700 mg/kg bw
No. of animals per sex per dose:
57
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
Statistics:
Calculation of LD50 was made by the method of Reed and Muench (1938).

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
36 700 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classidied
DSD: not classified