Registration Dossier

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:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Crl:CD (SD)BR

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
castor oil
Details on oral exposure:
Method of administration:
by 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: 5 animals at 0 mg/kg bw/day Male: 5 animals
at 50 mg/kg bw/day Male: 5 animals at 250 mg/kg
bw/day Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day Female: 5
animals at 50 mg/kg bw/day Female: 5 animals at
250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
at 1000 mk/kg/day group
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
at 1000 mk/kg/day group
Details on results:
Clinicalobservations:
No deaths occurred at any dose.
At the dose of 50 mg/kg/day, none of the examinations performed revealed any change attributable to treatment.
At the dose of 250 mg/kg/day, slight depression in body weight was observed in both sexes.
At the dose of 1000 mg/kg/day, transient salivation was the only clinical change observed in both sexes starting within 15 minutes of the test
article administration. Body weight appeared slightly affected (retarted growth).

Laboratoryfindings:
At the hematological examination and blood chemistry tests no treatment-related variations were found. At the urinalysis the only change noted was an increases in frequency of positive findings of urinal bililrubin in the males of the 1000 mk/kg/day group

Effects in organs:
Post-mortem examinations showed that the test product induced slight changes only in the stomach (degenerative foci of the gastric non glandular mucosa) indicative of slilght irritative properties of the test article on the stomach when administered at the dose of 1000 mg/kg/day.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
ca. 50 mg/kg bw/day (nominal)
Based on:
test mat.
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