Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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