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

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

other:

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

GLP compliance:

not specified

Remarks:

Not provided in information from NONS file (Corrigendum INQ-C-0000001810-82-01), as per inquiry number 06-0000021186-73-0000, permission to refer granted by ECHA.

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

401-540-3

EC Name:

-

Cas Number:

84632-65-5

Molecular formula:

C18H10Cl2N2O2

IUPAC Name:

3,6-bis(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: polyethylene glycol 400

Duration of treatment / exposure:

28 days

No. of animals per sex per dose:

5 males and 5 females

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

> 1 000 other: mg/kg bw

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

l. clinical observation:

Red discolored extremities were observed in the animals of the high dose group (1000 mg/kg) starting with day 21.

2. clinical chemistry/haematology:

No changes of toxicological significance at termination of the treatment.

3. necropsy findings/histopathology:

There was no evidence of histopatological findings resulting from treatment with TK 11627.