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Administrative data

Description of key information

Acute oral toxicity: similar to OECD TG 401: LD50 >5000 mg/kg bw.

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
Study period:
Study period not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-OECD, Pre-GLP study without detailed documentation.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No details
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No details
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least daily
- Necropsy of survivors performed: not mentioned in the report
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
2/10 animals died. Death was observed on day 5 and 12.
Clinical signs:
Lethargy was observed.
Interpretation of results:
other: not classified: criteria not met
Remarks:
according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The acute oral toxicity test showed an LD50 of >5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD, pre-GLP) 10 rats were administered the test substance orally at a dose level of 5000 mg/kg bw. During the 14 -day observation period 2/10 rats died. Mortality was observed at day 5 and 12. The clinical sign observed was lethargy. The acute oral LD50 for the test substance in rats was determined to be >5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD, pre-GLP) 10 rats were administered the test substance orally at a dose level of 5000 mg/kg bw. During the 14 -day observation period 2/10 rats died. Mortality was observed at day 5 and 12. The clinical sign observed was lethargy. The acute oral LD50 for the test substance in rats was determined to be >5000 mg/kg bw.

Additional information:

In the acute oral toxicity study of Moreno, 1973 also a dermal toxicity study is included. The acute dermal toxicity study was conducted with 10 rabbits receiving a dermal application of 5000 mg/kg bw of the test material. The animals were observed for mortality and/or clinical signs for 14 days. No symptoms were observed and 0/10 animals died. The dermal LD50 exceeded 5000 mg/kg bw and this result does not have an impact on the classification.

Justification for classification or non-classification

The substance does not have to be classified for acute and dermal oral toxicity in accordance with EU CLP Regulation (EC) No. 1272/2008 and its amendments.

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