Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
GLP compliance:
not specified
Species:
rat
Strain:
other: Crl:CD BR
Sex:
male/female
Route of administration:
other: oral: diet
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
90 days
Frequency of treatment:
daily in diet
Remarks:
Doses / Concentrations:
0;200;1000;5000 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
15
Dose descriptor:
NOAEL
Effect level:
74 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: 90 days
Dose descriptor:
LOAEL
Effect level:
17 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: 90 days
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
17 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
In a 90d study according to US EPA for males the NOAEL was 74 mg/kg/d, for females the LOAEL 17 mg/kg/d

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification