Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Composition of test material, percentage of components: approximately 50% active compound in water

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: mean males 197 g, mean females 175 g
- Fasting period before study: 16 - 4
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The content of 50% active ingredient in the test substance was taken into account for dosis calculation.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: The treatment was tolerated without mortalites, clinical signs, effects on body weights and gross pathological findings.
Mortality:
no deaths
Clinical signs:
none
Body weight:
no effects on weight gain
Gross pathology:
no findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
(1st) 2000 0 / 3/ 3 --- --- 
(2nd) 2000 0 / 3/ 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs of toxicity after treatment / number of animals treated

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study performed according to OECD TG 423 a single oral dose of 2000 mg/kg bw was tolerated withouth mortalities, clinical signs, effects on weight gain and gross pathological findings. Thus, the LD50 was determined for the substance with > 2000 mg/kg bw.