Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to OECD 401, DIrective 84/449/EEC, B.1 and compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat, EMD
Strain:
other: Wi-AF/Han (SPF)
Sex:
male/female

Administration / exposure

Vehicle:
other: Distilled watercontaining 0.25% methocel

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 1500 mg/kg bw; Number of animals: 5; Number of deaths:0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths:0
Male: 3000 mg/kg bw; Number of animals: 5; Number of deaths:1
Female: 1500 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 4
Female: 3000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Clinical signs:
Signs of toxicity related to dosed levels:
Dydpnea, Iocomotor disturbance, piloerection, tremor, salivation, abnomina position, increased lacrimation, tonic-clonic convulsions, hemorrhagic lacrimation, retention of faeces, blood-crousted snout.
Symotoms beginning within 15 minutes after treatment.
duration until day 5.
Gross pathology:
Effects on organs: none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the data obtained from this study, the test substance would be assigned to GHS Category 5/unclassified.