(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: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

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:

male/female

Details on test animals or test system and environmental conditions:

Two groups of rats (5 males and 5 females) were used for the study.
TEST ANIMALS
- Source: Jai Research Foundation
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: male between 258 and 196 g; female between 184 and 162 g kg
- Housing: the rats are divided in two groups
- Diet:. ad libitum
- Water : ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 64-66%
- Air changes (per hr): min 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

other: 80% polyethylen glycol in distilled water

Remarks:

The test item is pratically not soluble in distilled water.

Duration of exposure:

4 h

Concentrations:

Rat from Group I were exposed to 80% polyethylene glycol in distilled water and served as the control group. Rats from Group II were exposed to the maximum achievable breathing zone concentration (2.865 mg/l air) of test item in 80% polyethylene glycol at the calculated nominal concentration of 23.111 mg/l of auer in the inhalation chamber.

No. of animals per sex per dose:

Two groups of rats (5 males and 5 females) were used for the study.

Control animals:

yes

Details on study design:

Observation period: 14 days
All rats were observed for any signs and mortality at hourly intervals during the 4 h exposure period and at 1 h after the exposure on the day of exposure. The surviving rats were observed twice a day for morbidity and mortality for a period of 14 day following exposure. The clinical signs were recorded once a day.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 865 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred at the maximum achievable breathing zone concentration.

Clinical signs:

other: nasal discharge, nasal irritation, lethargy

Body weight:

No effect.

Gross pathology:

No lesion of toxicological sigificance were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Since no mortality occurred at the maximum achievable breathing zone concentration of d-trans Allethrine 75/25 in 80% of polyethylene glycol at the calculated nominal concentration of 23.111 mg/l of aier, the substance was not classified for this endpoint.