Registration Dossier

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:
other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006, without detailed documentation.

Data source

Reference
Reference Type:
other: Body responsible for test
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Annex V, Method B1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
No. of animals per sex per dose:
5 Males
5 Females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mg/kg bw
Based on:
test mat.
Mortality:
Males 0/5
Females 0/5
Clinical signs:
Piloerection was observed in all rats within 22 minutes of dosing. There were no other clinical signs and recovery was complete in all animals by Day 2.
Gross pathology:
No macro-pathological abnormality revealed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test substance in rats is > 2,000 mg/kg bw.