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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptale restrictions
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no
Species:
other: Rat(TIF:RAIF)
Route of administration:
oral: unspecified
Vehicle:
other: 0.5% carboxymethylcellulose and 0.1% Tween 80 in distilled water
Details on oral exposure:
Method of administration:
Gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Details on results:
Clinical observations:
1 male and 1 female control died on day 21 with signs consistent with mis-dosing. 2controls(1 male, 1 female) suffered accidental death on day of scheduled sacrifice. Top dose males showed slightly decreased body weights. persisting during recovery.
Laboratory findings:
in females, increased ALT levels (25-31%) were noted in groups 3 and 4; a smaller increase (10%) persisted after recovery.
Effects in organs:
A small(12%) increase was seen in relative kidney weights in top dose females; a smaller increase (7%) persisted after recovery. There were no treatment-related macroscopic or microscopic changes.
Dose descriptor:
NOAEL
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
ca. 50 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Critical effects observed:
not specified
Conclusions:
Classified as : Not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification