Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 4.1.1996 to 9.9.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test is done under GLP and following OECD Guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: young adult
- Weight at study initiation: males 117-141 g; females: 123-140g
- Housing: in groups of up to five by sex in solid-floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 ml/kg
Doses:
2000 mg/Kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 1 and 4 hours after dosing and subsequently once daily for 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: only 1/5 females died, no male died
Mortality:
One female animal was found dead five hours after dosing
Clinical signs:
Ante mortem signs were restricted to prone position
Body weight:
The bodyweight gain for the surviving animals was generally slightly less than expected for rats of this age and strain.
Gross pathology:
Macroscopic examination of the decedent did not reveal any abnormality. No significant lesion was evident after necropsy of the surviving animals.

Any other information on results incl. tables

   Mortality    
 Dosage (mg/kg)  Male  Female  Combined
 2000  0/5  1/5  1/10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg in rats.
Executive summary:

The acute toxicity of the subctance was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg according to OECD guideline 401. The animals were starved overnight prior to dosing. The test material was administered at a constant volume-dosage of 10 ml/kg in maize oil.

Mortality and signs of reaction to treatment were recorded during a subsequent 14 -day observation period; the surviving animals were killed on the following day. All animals were subjected to necropsy. Only one female rat died during the observation period.

Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.