(RS)-3-Allyl-2-methyl-4-oxocyclopent-2- enyl (1R,3R)-2,2-dimethyl-3-(2-methyl prop-1-enyl)-cyclopropanecarboxylate (mixture of 2 isomers 1R trans: 1R/S only 1:3) (Esbiothrin)

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Reference

Name:

Unnamed

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Purity : 96.7 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Acclimatisation period of 6 days for rats no. 1 and 3, 8 days for rats no. 4 to 6 and 5 days for rats 7 to 9.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The test substance was found to be miscible in 0.5%(w/v) carboxymethyl cellulose in distilled water.
The required quantity (2000 mg for Set I and 300 mg for Set II and III) of test item was mixed in 0.5%(w/v) carboxymethyl cellulose in distilled water and the final volume was made up to 10 ml..

Doses:

2000 mg/kg
300 mg/kg

No. of animals per sex per dose:

3

Details on study design:

The rats were observed for signs of toxicity and mortality at 30 minutes, 1, 2, 3, 4 and 6 hours post dosing on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality for a period of 14 day following oral dosing. The clinical signs were recorded once a day. Individual body weight were recorded prior to dosing on day 0, 7 and 14 following oral dosing and at death.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

500 mg/kg bw

Based on:

test mat.

Mortality:

2 rats from Set I treated with 2000 mg b.w were found dead on the day of dosing and the third rat was found dead on day 1 post dosing.
No mortality was observed for the second set of 3 females rats treated with a single dose fo 300 mg b.w.

Clinical signs:

The toxic sign of tremor was observed in the rats treated with 2000 and 300 mg b.w. on the day of dosing. The tremor was likely to be more severe in rats from Set I as compared from animals from Set II and III. All the rats treated at the dose level of 300 mg/kg b.w. appeared normal from day one post dosing till termination.

Body weight:

Normal gain in body weights were recorded in all the surviving rats (set II and III) treated at the dose level of 300 mg/kg.

Gross pathology:

Visceral examination of the rats sacrificed at the termination did not reveal any lesion of significance. The rats that died during the post dosing observation period showed various lesions in the lung : congestion and oedema and liver mottling.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral median lethal dose LD50 (cut off value) of d-trans Allethrin 75/25 in Wistar rats was found to be 500 mg/kg b.w.