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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
Study period:
7 Jul 1984 to 14 Aug 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Detailed study summary is provided

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)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
9-Octadecenoic acid, 12-hydroxy-, [R-(Z)]-, mono- and diester with glycerol
EC Number:
294-606-4
EC Name:
9-Octadecenoic acid, 12-hydroxy-, [R-(Z)]-, mono- and diester with glycerol
Cas Number:
91744-44-4
IUPAC Name:
9-Octadecenoic acid, 12-hydroxy-, (R-(Z))-, mono- and diester withglycerol
Specific details on test material used for the study:
Name as cited in study report: Loxiol G11

Test animals

Species:
rat
Strain:
Wistar
Remarks:
TNO
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann GmbH
- Weight at study initiation (mean): male: 174g / female: 141g
- Fasting period before study: yes, duration not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
propylene glycol
Details on oral exposure:



MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

Doses:
A single dose of 5000 mg/kg on an empty stomach
No. of animals per sex per dose:
5 male and 5 female per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0% for male and female
Clinical signs:
The first five hours of application the animals had a ruffled fur
Gross pathology:
Hydrometra in one animal

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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