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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:
weight of evidence
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment: Non-GLP study; no data about purity and no certificate of analysis of the test substance; no details on age, gender, weight and strain of rats and housing conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimetol

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
None

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
None
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total no. of animals = 10
Control animals:
no
Details on study design:
- Animals were observed for mortality and clinical signs of toxicity for 14 days.
- Necropsy performed: Yes
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
- 2/10 animals died on Day 1.
Clinical signs:
- At 2 h, lethargy, ataxia and loss of righting reflex were noted in animals.
- At 24 h, lethargy in 3/8 animals and piloerection in 2/8 animals were noted.
Body weight:
No data
Gross pathology:
At necropsy, lungs and stomach were red in 2 animals.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 for Dimetol is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.
Executive summary:

In an acute oral toxicity study, 10 rats were given a single oral dose of Dimetol at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

Two of the 10 rats died on Day 1. At 2 h, lethargy, ataxia and loss of righting reflex were noted in rats. At 24 h, lethargy in 3/8 rats and piloerection in 2/8 rats were noted. At necropsy, lungs and stomach were red in 2 rats.

The oral LD50 for Dimetol is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.