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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term 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:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Version / remarks:
EEC B.7
GLP compliance:
yes
Limit test:
no

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
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 40 mg/kg bw/day
Male: 5 animals at 125 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 40 mg/kg bw/day
Female: 5 animals at 125 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day

Examinations

Observations and examinations performed and frequency:
Clinical observations:
No clinical signs related to treatment were observed at any dose level

Laboratory findings
Significant body weight reductions in high dose males and females were accompanied by significantly reduced food consumption indicating weight reduction was due to non-palability of food rather than a toxic effect. Scattered incidences of hematological and biochemical findings without a dose response are not indicative of toxicity and have no toxicological significance.
Sacrifice and pathology:
Effects in organs:
Changes were noted in the livers of male and female rats at all dose levels and in the kidneys of male rats at all doses. Hepatic changes included increased weight plus hepatocytomegally. This indicates liver enzyme induction which should not be viewed as a toxic effect. Changes noted in the kidneys of male rats included histopathological lesions characteristic of male rat "hydrocarbon nephropathy" and are related to the accumulation of the male rat-specific protein, alpha 2mu globulin which is produced only by the male rat. Therefore, these kidney effects have no biological significance to other species.

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion