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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Jun - 27 Sep 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no data on test substance purity, only 2 animals per sex/dose).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no data on test substance purity, only 2 animals per sex/dose)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan, (Z)-9-octadecenoate (2:3)
EC Number:
232-360-1
EC Name:
Sorbitan, (Z)-9-octadecenoate (2:3)
Cas Number:
8007-43-0
Molecular formula:
C42H76O7
IUPAC Name:
(1R)-1-[(2R,3R,4S)-4-hydroxy-3-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]-2-[(9Z)-octadec-9-enoyloxy]ethyl (9Z)-octadec-9-enoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl (9Z)-octadec-9-enoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]ethyl (9Z)-octadec-9-enoate
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Substance type: organic
- Physical state: yellow clear liquid, water insoluble
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 198 g (males), 163 g (females)
- Fasting period before study: 15 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
Doses:
5,000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 h, 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study period.
Clinical signs:
other: During the 14 day observation period, no symptoms of acute intoxication were observed at all.
Gross pathology:
14 days after the treatment, the inner organs of all the animals were without any pathological findings.

Any other information on results incl. tables

Table 1: Average body weights of the 2 male and the 2 female rats in g.

sex

before application

24 h

7 days

14 days

after treatment

male

198

202

232

255

female

163

164

176

181

 

Applicant's summary and conclusion

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