Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 17 - June 09, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterize

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
and 21 CFR 28
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles Rivers
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: 112 to 134 g- male; 118-138 g-females
- Fasting period before study: overnight.
- Housing: individually in hanging stainless steel cage
- Diet: Certified Rodent Chow ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days before

ENVIRONMENTAL CONDITIONS
- Temperature: 71 - 72°F
- Humidity : Ambient
- Photoperiod :12hrs light/12rhs dark

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
Using all available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.
dose level: 0, 500, 1000, 2000 mg/kg
concentration: 10 ml/kg
Doses:
Single dose: 2g/kgBW at a dose level of 20ml/kgBW
No. of animals per sex per dose:
5 females/males per dose
Control animals:
no
Details on study design:
All animals were observed frequently on day of dosing and daily thereafter for at least 13 days after treatment for a total of 14 days. Day of treatment = day 0.
Daily observations included signs of toxicity in addition to lethality.
Animals weighed on day 0, day 7 and day 13.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was 0 (zero) mortality
Clinical signs:
Decreased activity observed in all rats following treatment.
Diarrhoea in 1 male and 2 females.
Except for decreased activity in 1 female on day after treatment, all signs of toxicity were confined to the day of treatment.
Body weight:
No treatment related effects on body weight were apparant during weeks one and two of the observation period.
Gross pathology:
No gross morphological abnormalities found.
Other findings:
No apparent effects on body weights or gross morphological abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was greater than the limit dose of 2000mg/kgBW