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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Study performed in 1994 and precise chemical composition not clear. The material tested was a commercial grade of the substance.
As the substance appears to be of low hazard, this study is considered valid
Further animal testing cannot be justified

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Only trade name provided in the test report. Probably commercial grade mixture with glycol present.
Brown/yellow liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Five males and five females

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Single dose of 2000 mg/kg
No. of animals per sex per dose:
Five
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Piloerection and increased salivation were observed in all rats within five minutes of dosing and during the remainder of Day 1. In addition, residual dose (associated with the increased salivation) was apparent on Day 1.
There were no other clinical signs
Body weight:
Slightly low body weight gains were recorded for one male and two females on Day 8; these rats achieved anticipated gains on Day 15.
Gross pathology:
No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although the nature of the test material was not reoprted, the material of the trade name used in the report is typically 70% actives.
Even taking into account the level of actives and the maximum dose of 2000 mg/kg of the commercial grade material with solvent present, it can be predicted that the disciminating dose for the pure active would be below limits for classification.