Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
10 female SPF-\!lstar-Rats , Strain Hoe: WlSKf(SPF 7:)
Weight: 160- 178 g (Average: 166 g)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil; 25 % suspension w/v
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
Single application by gavage
Observation period: 14 days

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
squatting posture, piloerection, accelerated respiration
Body weight:
normal development
Gross pathology:
no adverse findings
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 was above 5000 mg/kg bw in female Wistar rats after single gavage
Executive summary:

The test item was administered once by gavage as a 25 % suspension in sesame oil (w/v) to ten female Wistar rats. Afterwards anmilas showed squatting posture, piloerection and accelerated respiration. Observations were recorded for 14 days before a gross necropsy was performed. No pathological changes were observed at the end of the study.

The acute oral LD50 was above 5000 mg/kg bw in female Wistar rats after single gavage.