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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 96/54 B.7.
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1

Test animals

Species:
other: Han RCC:WIST (SPF) rat

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Desiccated corn oil.
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: 5 animals at 30 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 750 mg/kg bw/day
Female: 5 animals at 30 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 750 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
All animals survided until scheduled necropsy.

Ataxia and somnolence were observed persistently in the 750
mg/kg dose treated rats. Among females, addtionally
piloerection and prostration were noted sporadically.

In the higher dose treated rats, reduced locomotor activity,
reduced food consumption, slightly reduced body weight were
observed.

Laboratory findings:
In higher dose treatd females, elevated chlosterol and
alanine aminotransferase were observed and considered to be
of adaptative changes.

Effects in organs:
Elevated liver-to-body weights in higher dose treated rats
were observed and attributed to metabolic adaptation.


In the kidneys of higher dose treated males, moderate
severity hyaline change in the cortical tubules was
observed. Brain and kidney lesions observed in the 30 and
150 mg/kg treated animals were observed.

Effect levels

Dose descriptor:
NOAEL
Effect level:
30 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