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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Sex:
male/female
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
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no mortality found.
Clinical signs:
unspecific clinical signs such as piloerection,salivation and hunched postur immediately after treatment and persisted up to the observation day 2.
Body weight:
Normal body weight development recorded.
Gross pathology:
No gross pathology performed.

Each 5 male and female rats were treated with test material at dose of 2000 mg/kg bw.

Unspecific clinical signs such as piloerection,salivation and hunched posture were observed starting immediately after the treatement at dose of 2000 mg/kg bw and persisted up to observation day of 2. No effect was found onwards. The LD50 is determined to be higher than 2000 mg/kg bw for rats.

Interpretation of results:
GHS criteria not met
Conclusions:
The registration substance was investigated for its acute oral toxicity according to OECD 401. The LD50 was found to be higher than 2000 mg/kg bw.
Executive summary:

The registration substance was investigated for its acute oral toxicity according to OECD 401. Unspecific toxicity occured such as piloerection, salivation and hunched posture starting immediately after treatment at dose of 2000 mg/kg bw. By the observation day 3 the treated animals seemed to be fully recovered. The LD50 is determined to be higher than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
One valid study.

Additional information

Justification for classification or non-classification

The acute oral toxicity of the registration substance was investigated according to the Guideline OECD 401. Ten rats were treated per gavage at dose of 2000 mg/kg bw and all animals survived. No classification is justified.

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