Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
other: ECHA inquiry result
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat(TIF:RAIF)

Administration / exposure

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

Results and discussion

Results of examinations

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.

Effect levels

open allclose all
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

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as : Not classified