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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
Dose level: 0, 8, 40, 200, 1000 mg/kg bw/day
Basis:

No. of animals per sex per dose:
6

Results and discussion

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

Any other information on results incl. tables

Mortality data: There were no deaths during the study period.

Clinical observations: No treatment-related observations.

Bodyweight: No abnormalities were noted in the dosing period.

Food Consumption: No abnormalities were noted during the dosing period.

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.

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 of the 1000 mg/kg/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/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.

Applicant's summary and conclusion

Conclusions:
NOAEL = 1000 mg/kg bw/day