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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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-1H,2H,4H,5H-pyrrolo[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.