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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
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: General overview of study results is presented, in accordance with EPA reporting rule on certain pesticide inert ingredients. No specific methodology is detailed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Section 8 (d) of the Toxic Substances Control Act (Fed. Vol. 54, No. 38, Tuesday, February 28, 1989)
Deviations:
not specified
Principles of method if other than guideline:
EPA reporting rule on certain pesticide inert ingredients. No specific methodology is detailed.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: not specified.
Details on test material:
Not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
Not specified
Doses:
Not specified
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Details on study design:
Not specified
Statistics:
Not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 000 other: mg/kg
Based on:
not specified
Mortality:
No deaths
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 1000 mg/kg. It should be noted that this study could be waived as it is not relevant to the expected exposure to the substance. This is in accordance with Annex VII, Section 8.5.1 which states that
8.5.1. By oral route - The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available.”
However, this study is included as supporting information to fulfil this data endpoint.
Although a limit test at > 1000 mg/kg no classification is proposed for oral toxicity, as this route of exposure is not anticipated.
Executive summary:

LD50 > 1000 mg/kg. It should be noted that this study could be waived as it is not relevant to the expected exposure to the substance. This is in accordance with Annex VII, Section 8.5.1 which states that:

8.5.1. By oral route - The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available.”

However, this study is included as supporting information to fulfil this data endpoint.

Although a limit test at > 1000 mg/kg no classification is proposed for oral toxicity, as this route of exposure is not anticipated.