Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-03-04 to 1991 03-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well-documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Preliminary study; for each dose levels of 500, 1000 and 2000 mg/kg bw one male and one female rats were used. No significant effects were found.

Results and discussion

Preliminary study:
No effect found
Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality found
Clinical signs:
Within 24 hours: increased respiration rate, squatting posture, sunken flanks, stilted and uncordinated gait, decreased spantaenous activity, bristling coat
Body weight:
Not impaired in the observation period of 14 days
Gross pathology:
No effect

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the registration substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.
Executive summary:

The acute oral toxicity of the registration substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.