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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
repeated dose toxicity: oral
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 96/54EEC, B.7 Repeated Dose (28 days) Toxicity (oral), 1996
GLP compliance:
yes
Limit test:
yes

Test animals

Species:
other: Wistar rats, male and female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
polyethylene glycol
Details on oral exposure:
Method of administration:
daily 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: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
50mg/kg/day: No treatment related findings.

150mg/kg/day: Slightly reduced body weight (gain) in
females.

1000 mg/kg/day: Slightly reduced body weight (gain) in males

and females.


Clinical signs noted were salivation, alopecia, wounds,
scabs, hunched posture, vomiting (regurgitation) and
hyperthermia among some animals.

Laboratory findings:
Significant increases in ASAT and ALT were observed in males
treated with 1000mg/kg. Increases in AST, although not
significant, were also seen at the lower doses in males. In
addition significant increases in cholestrol were observed
in females treated with 1000mg/kg/day.

Haematology revealed no abnormalities, apart from a reduced
platelet count of one dose male. This male also displayed
an increased aspartate aminotransferase and alkaline
phosphatase activity.

Effects in organs:
Pelvic dilation was observed in the kidneys of 1 male
treated with 1000 mg/kg. Fluid in the uterus was observed
in 2 females treated with 1000 mg/kg. Enlarged mandibular
lymph nodes were observed in females treated with 150 mg/kg
and 1000mg/kg. Significant decreases in liver/body weight
ratio was observed in males treated with 1000 mg/kg.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
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