Registration Dossier

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)
Rationale for reliability incl. deficiencies:
other: Reliability is assumed to be 1 as data are migrated from NONS files

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-920-6
EC Name:
-
Cas Number:
88949-33-1
Molecular formula:
C30H20N2O2
IUPAC Name:
3,6-bis({[1,1'-biphenyl]-4-yl})-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rat, Wistar, SPF

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Method of administration:
gavage
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 200 and 1000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 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 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Control animals:
yes

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Faeses and fur were discoloured red in all treatment groups.
Laboratory findings:
Haematological parameters of the treated animals are in the same range as control animals. Biochemistry parameters of treated animals are comparable to the control animals.
Effects in organs:
Most of the animals showed an enlargement of the caecum after 4 weeks. The control animals showed liquid caecal contents.
The gastro-intestinal tract was discoloured red in dose groups.
An increase of the realative kidney weight was observed in males in the high dose group; the absolute kidney weights were not significantly increased.
There are no differences between control- and recovery group.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
200 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:
In a study according to EU Test Method B.7 (under GLP conditions), the registered substance PR 264 had a NOAEL of 1000 mg/kg bodyweight.
Executive summary:

In a study according to EU Test Method B.7 (under GLP conditions), the registered substance PR 264 had a NOAEL of 1000 mg/kg bodyweight.