Registration Dossier

Administrative data

Endpoint:
short-term 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: Assessed after consultation with the relevant Authority. Data migrated from NONS (67/548/EEC notification) files provided by Authority contained insufficient information.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Guidelines for Chemical Substances Control Law of Japan (1986)
GLP compliance:
yes
Remarks:
No further information was provided in the SNIF file.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Analytical purity: no data

Test animals

Species:
rat
Strain:
other: Charles River CD(R)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Test duration: 28 days, including an unspecified recovery period.
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 10, 50, 200 mg/kg bw/day
Basis:
no data
No. of animals per sex per dose:
Control: 5
10 mg/kg bw/day: 5
50 mg/kg bw/day: 5
200 mg/kg bw/day: 10
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Haematological findings:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Details on results:
FOOD EFFICIENCY
Poor food efficiency during exposure in the 200 mg/kg bw/day groups. During the post-exposure period the food efficiency was normal.

HAEMATOLOGY
Males in the 200 mg/kg bw/d group had a slightly increased erythrocyte level. Irregularities in the blood values of male and female animals were
observed. The prothrombin time was longer in the 200 mg/kg bw/d dose groups and in males dosed with 50 mg/kg bw/d.

GROSS PATHOLOGY
Increased liver weight in animals dosed with 200 mg/kg bw/d.

HISTOPATHOLOGY:
No deviations were reported.

Effect levels

Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
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