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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.7; OECD 407 (1981)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
402-400-4
EC Name:
-
Cas Number:
54660-00-3
Molecular formula:
C18H12N2O2
IUPAC Name:
3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

Test animals

Species:
rat
Strain:
other: Wistar KFM-Han.
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
Method of administration: Magensonde
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
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 100 mg/kg bw/day
Male: 5 animals at 300 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 100 mg/kg bw/day
Female: 5 animals at 300 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No mortalities occured. None of the parameters measured during the course of the experiment and at the end of the experiment exhibitet any substance-specific influence. They were all located within the spectrum of the spontaneous pathological variation for the age group of the species.

Laboratory finding:
None of the parameters measured during the course of the experiment and at the end of the experiment exhibitet any substance-specific influence. They were all located within the spectrum of the spontaneous pathological variation for the age group of the species.

Effects in organs:
None of the parameters measured during the course of the experiment and at the end of the experiment exhibitet any substance-specific influence. They were all located within the spectrum of the spontaneous pathological variation for the age group of the species.

Effect levels

Dose descriptor:
NOEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified
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:
Not classified.