Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.1; OECD 401 (1981)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar KFM-Han. (SPF-quality)
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 5000 mg/kg bw; No. of animals: 5; No. of death:0
Female: 5000 mg/kg bw; No. of animals: 5; No. of death:0
Clinical signs:
Signs of toxicity related to dose levels:
Symptoms typically found in acute toxicity test such as dyspnoea, sedation, rattling sounds above the lung, hunched posture, piloerection. The extremities were stained red as a result of the pigment. All of the animals recovered within 3 days after administation.
Gross pathology:
Effects on organs:
No macroscopic changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU