Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis([1,1'-biphenyl]-4-yl)-2,5-dihydro-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was performed following GLP standards and standard acute method following EEC. B1 guidelines. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

EEC.B1

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

3,6- bis-biphenyl-4-yl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

IUPAC Name:

3,6- bis-biphenyl-4-yl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Vehicle:

polyethylene glycol

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No signs of toxicity observed

Gross pathology:

Effects on organs:No treatment related abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a study carried out in accordance with GLP and EEC guideline B.1, test substance (EC No. 413-920-6) was evaluated for its acute oral toxicity potential by standard acute method at dose level of 2000 mg/kg bw in male and female wistar rats. LD50 value for acute oral toxicity was found to be greater than 2000 mg/kg bw. So test substance was not classified for acute oral toxicity according to Regulation (EU) 1272/2008.