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)
Rationale for reliability incl. deficiencies:
other: Annex V guideline study with GLP compliance

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat (Crj: CD(SD))

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
Details on oral exposure:
Method administration:
gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 6 animals at 0 mg/kg bw/day
Male: 6 animals at 8 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day

Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 8 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
CLINICAL OBSERVATIONS:
MORTALITY DATA:
There were no deaths during the study.

CLINICAL OBSERVATIONS:
No treatment-related observations.


BODY WEIGHT:
No abnormalities were noted in the dosing period

FOOD CONSUMPTION:
No abnormalities were noted during the dosing period


LABORATORY FINDINGS:
HAEMATOLOGY:
No abnormalities were noted at the end of the study period

BLOOD CHEMISTRY:
No abnormalities were noted at the end of the study period


EFECTS IN ORGANS:
NECROPSY:
No abnormalities were noted at necropsy at the end of the study period


ORGAN WEIGHTS:
Increased absolute and relative liver weights were noted in males at 1000 mg/kg bw/day dose group. No other related changes were noted.


HISTOPATHOLOGY:
No treatment-related effects were observed.

Cyst formation in the kidney was noted in both sexes of the 1000 mg/kg bw/day dose groups. This was not considered to be due to the test substance as this observation is common in this strain of rat and was also noted in control group animals.

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:
Classified as: Not classified