Registration Dossier

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:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity 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

Reference
Name:
Unnamed
Type:
Constituent

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.

Applicant's summary and conclusion