Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12.10.1998 - 04.02.1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according the OECD Principles of Good Labaratory Practice and the"Chemikaliengesetz" of the F ederal Republic of Germany. No guideline was followed. However, the test is very well described and is considered reliable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Principles of method if other than guideline:
OECD Principles of Good Labaratory Practice
OECD Environment Monograph No. 73
"Chemikaliengesetz" of the F ederal Republic of Germany.
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: fluid
Details on test material:
- Lot/batch No.: WB501
- Expiration date of the lot/batch: August 31, 2000

Test animals

Species:
rat
Strain:
other: Chbb:THOM
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 49 days
- Weight at study initiation: 132-200 g
-

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: An extended acute-toxic-class (ATC) method was used: Initially 2000 mg/kg were given to
1 male and 1 female. After the dose was not tolerated, a further group was treated with 200 mg/kg.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg male/female: 2 ml/kg
200 mg/kg group: 0.2 ml/kg

Doses:
2000 mg/kg
200 mg/kg
No. of animals per sex per dose:
2000 mg/kg: 1 male, 1 female
200 mg/kg: 3 male, 3 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: ALD
Effect level:
> 200 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg: Both animals died withing approx. 4.5 hours.
200 mg/kg: No animal died after administration and through the end of the experiment.
Clinical signs:
2000 mg/kg: Ataxia, breathing difficulties, tonic-clonic cramps, found dead approx. 4.5 hours after administration
200 mg/kg: Salivation, abdominal pain reactions during the administration day. No toxic symptoms from day 2 until end of observation
Body weight:
The body weight gain of male and female rats treated with 200 mg/kg remained within the normal range.
Gross pathology:
No gross lessions were seen during necropsy.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the German "Chemikaliengesetz" (Chemical Act) the toxicity of the test substance is to be classified: "injurious to health" (R22)