Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Some information in this page has been claimed confidential.

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation: 149-163 g for male, 126-140 g for female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40% w/v
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was weighed immediately prior to treatment, 7 and 14 days after post-treatment observation period. The rats were observed each hour to 6hr, after that, 2 times for one day during this time for signs of toxicity.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, organ weights, gross pathology
Statistics:
Not applicable because of no fatality

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
The test substance did not cause any changes in body weight.
Gross pathology:
No macroscopic abnormalities that could be attributed to treatment with the test substance were seen on pathological examination.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was evaluated for acute oral toxicity following OECD guideline 401. The test substance was non-toxic in rats at doses up to 2000 mg/kg bw. GHS criteria for acute oral toxicity classification are not met.