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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dihydroxypropyl oleate
EC Number:
203-827-7
EC Name:
2,3-dihydroxypropyl oleate
Cas Number:
111-03-5
Molecular formula:
C21H40O4
IUPAC Name:
2,3-dihydroxypropyl (9Z)-octadec-9-enoate
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Taiyo Kagaku; 401160
- Purity test date: 99.93 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Crj:CD(SD)IGS
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 123 - 125 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
There were no abnormalities in general condition in any animal.
Body weight:
There were no abnormalities in body weight in any animal.
Gross pathology:
There were no abnormalities in gross pathological findings in any animal.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
A single dose oral toxicity test of 2,3-dihydroxypropyl 9-cis-octadecenoate in rats allowed classification of the chemical into category 5 of the GHS regarding acute toxicity which does not result in any classification as to the CLP regulation.
There were no abnormalities in general condition, body weight or gross pathological findings in any animal.

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