(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)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Jai Research Foundation
- Age at study initiation: 20 to 21 weeks
- Weight at study initiation: minimum 2.158 max 2.400 kg
- Housing: individual rabbit
- Diet:. ad libitum):
- Water : ad libitum
- Acclimation period: 5 to 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 64-65%
- Air changes (per hr): min 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A volume of 0.5 ml test item was aplied evenly to the clipped intact skin of rabbit.

Duration of treatment / exposure:

The treated and the control sites were covered with gauze patches secured at the margins by non-irritating tape for a period of four hours.

Observation period:

The skin reactions of all rabbits were observed and scored at 1, 24, 48 and 72 hours; at day 7 post patch removal (for rabbit 1) only

Number of animals:

3 healthy adult, male albino rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0.33 - <= 1

Max. score:

1

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

At 24 h post patch removal, very slight erythema and no oedema was observed on the treated site of the rabbits.
At 48 h post patch removal, very slight erythema and no oedema was observed on the treated site of the rabbits no. 1 and 2 , and no erhytema and no oedema was observed on the treated site of the rabbits no.3.
At 72 h post patch removal, very slight erythema and no oedema was observed on the treated site of the rabbit no. 1 , and the treated site of rabbit no. 2 and 3 appeared normal.
At day 7 post patch removal the treated site of rabbit no. 1 appeared normal.

Other effects:

No clinical signs in any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Since the mean scores of erythema and oedema following observation at 24,48,72 hours post patch removal were not significant in any of the tested rabbits, d-trans Allethrin was not classified as irritant for the skin.