Registration Dossier

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Deviations:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CD® (SD) IGS BR
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITYThere were no deaths and no clinical signs related to the treatment with the test material.BODY WEIGHT AND WEIGHT GAINBodyweight gain was considered to be unaffected by treatment.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)Food consumption was considered to be unaffected by treatment.FOOD EFFICIENCYFood conversion efficiency was considered to be unaffected by treatment.HAEMATOLOGYThere were no haematologival changes which were considered to be related to treatment.A few inter-group differences attained statistical significance but there were minor, seen in one sex only and were considered to have arisen by chance.CLINICAL CHEMISTRYNo clinical chemistry changes which were considered to be related with treatment.NEUROBEHAVIOURThere were no inter-group differences in arena observations that were considered to be associated with treatment.Landing footsplay and grip strength measurements showed some inter-group variation during week 4 of treatment and some differences achieved statistical significance. There were, however, no consistent trends and many of the differences were apparent before commencement of treatment, an association with treatment was therefore discounted. Motor activity was unaffected by treatment.ORGAN WEIGHTSOrgan weights were unaffected by treatment.GROSS PATHOLOGYMacroscopic examination of animals killed on completion of the treatment period did not reveal any treatment-related findings.HISTOPATHOLOGY: NON-NEOPLASTICThere were no microscopic findings which were attributable to treatment with the test material. All microscopic findings were considered to be incidental and of no toxicological importance.

Effect levels

Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion