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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: no data
GLP compliance:
no
Species:
rat
Sex:
male/female
Route of administration:
oral: feed
Duration of treatment / exposure:
2 years; 5 animals per sex of both the treated and the control group were killed after 15 weeks treatment plus one week post exposure
Frequency of treatment:
daily
Post exposure period:
3-5 days for the 2-years treatment and control group; 7 days for the 15 weeks treatment and control group
Remarks:
Doses / Concentrations:
100 mg/kg bw/day
Basis:
nominal in diet
No. of animals per sex per dose:
treatment group:25 per sex of which 5 were killed after 15 weeks of treatment plus one week post exposure
control group: 15 per sex of which 5 were killed after 15 weeks of treatment plus one week post exposure
Control animals:
yes, concurrent no treatment
Observations and examinations performed and frequency:
No effects seen in either the 15 weeks or the 2 years groups
Dose descriptor:
NOAEL
Effect level:
> 100 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects seen
Remarks on result:
not determinable
Remarks:
no NOAEL identified. Effect type:carcinogenicity (migrated information)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

Based on the available 2 -year oral feed study which shows no effects at a level of 100 mg/kg bw/day in rats (male/female) the substance must not be classified.

Additional information