Reaction mass of 3-phenoxybenzyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate and 3-phenoxybenzyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate (4:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb - May 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP / guideline study without deviations

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

d-Phenothrin

IUPAC Name:

d-Phenothrin

Constituent 2

Reference substance name:

Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)

IUPAC Name:

Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)

Constituent 3

Reference substance name:

188023-86-1

Cas Number:

188023-86-1

IUPAC Name:

188023-86-1

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): d-Phenothrin
- Physical state: yellow to brown transparent viscous liquid
- Purity test date: 25 August 2005
- Lot/batch No.: S5237276801
- Expiration date of the lot/batch: July 2008
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 18 - 19 weeks
- Weight at study initiation: 2.085 - 2.478 kg
- Housing: individual in stainless steel wire meshed cages
- Diet (e.g. ad libitum): rabbit pellet feed ad libitum
- Water (e.g. ad libitum): charcoal filtered and UV sterilised tap water ad libitum
- Acclimation period: 6 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 65 - 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2006-04-20 To: 2006-04-25

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using cotton soaked with distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No edema or erythrema were observed in any of the animals at 24, 48 and 72 h scoring points.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean dermal irritation score of erythema and oedema (following 24, 48 and 72 h observation) was 0.00 and as a result d-phenothrin was not classified for skin irritation in this study according to the criteria of Regulation 1272/2008.

Executive summary:

This study was performed to assess the acute dermal irritation potential of d-Phenothrin in New Zealand White rabbits. The method followed was as per the guidelines of OECD N° 404 (April 2002). 

Three healthy, adult male albino rabbits of the New Zealand White strain were selected for the study. Initially one rabbit was tested with a single patch for a period of 4 hours. Based on the observation at 24 hour post patch removal, the irritation response was confirmed by testing two additional rabbits simultaneously. A gauze patch with 0.5 mL of d-Phenothrin was applied evenly to the intact skin of rabbits and secured at the margins by non-irritating tape for a period of four hours. At the end of the exposure period, the residual test substance was removed with cotton soaked in distilled water. The skin reactions were observed at 1, 24, 48 and 72 h post patch removal and dermal irritation reaction was scored. The control skin site of the rabbits was applied 0.5 mL of distilled water and was normal throughout the experimental period.

The mean dermal irritation score of erythema and oedema (following 24, 48 and 72 h observation) was 0.00 and as a result d-phenothrin was not classified for skin irritation in this study.