Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-01-12 to 2005-02-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
The test substance is not adequately characterized and insufficient information is provided on the test animals.
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
The test substance is not adequately characterized and insufficient information is provided on the test animals.
GLP compliance:
no
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: T 1481

Test animals

Species:
mouse
Strain:
other: outbred albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 18-22 grams
- Fasting period before study: animals were fasted, however, fasting period not provided.
- Housing: no data
- Diet: no data
- Water: no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES:
- no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: arachis oil BP
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle: no data
- Justification for choice of vehicle: no data
- Lot/batch no.: no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED:
- no data

DOSAGE PREPARATION:
- no data


CLASS METHOD:
- Rationale for the selection of the starting dose: no data
Doses:
300 and 2000 mg/kg bodyweight
No. of animals per sex per dose:
Three animals per group. There were two groups at 300 mg/kg bw dose level and one group at 2000 mg/kg bw dose level.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical observations were noted at 30 minutes, 1, 2, 4 hours after dosing, and daily from days 1-14 following administration. Body weights were recorded on days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
300 - 500 mg/kg bw
Mortality:
There were no deaths noted in animals treated at a dose level of 300 mg/kg. All animals treated at a dose level of 2000 mg/kg were found dead or killed in extremis during the day of dosing.
Clinical signs:
Hunched posture, lethargy and ptosis were noted, during the day of dosing, in animals treated at a dose level of 300 mg/kg. Animals treated at a dose level of 300 mg/kg appeared normal four hours or one day after dosing. Signs of systemic toxicity noted, during the day of dosing, in animals treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia, decreased respiratory rate, laboured respiration, ptosis, splayed gait, loss of righting reflex, hypothermia and coma.
Body weight:
No significant changes noted.
Gross pathology:
No abnormalities noted.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral LD50 of the test substance in the female outbred albino mouse was estimated to be in the range of 300 to 500 mg/kg bodyweight.