Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: Appraisal of the safety of chemicals in foods, drugs and cosmetics (FDA)
GLP compliance:
not specified
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
0.71; 1.00; 1.41; 2.00 g/kg bw
No. of animals per sex per dose:
10 animals in total
Sex:
male/female
Dose descriptor:
LD50
Effect level:
980 mg/kg bw
Based on:
test mat.
Interpretation of results:
harmful
Remarks:
Migrated information Xn;R22 Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
980 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

With an LD50 (oral, rat) of 980 mg/kg the substance must be classified for acute toxicity category 4 with H302 (harmful if swallowed)