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)

Eye irritation

Administrative data

Endpoint:

eye 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 with no deficiencies

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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002 version

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.140 - 2.357 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 - 67
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2006-04-24 To: 2006-04-29

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with saline
- Time after start of exposure: 24 h

SCORING SYSTEM: OECD TG 405

TOOL USED TO ASSESS SCORE: ophthalmoscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was found non-irritant in this in vivo study and consequnetly is not callsified as irritating to eyes according to the criteria of Regulation 1272/2008.

Executive summary:

This study was performed to assess the acute eye irritation potential of d-Phenothrin in New Zealand White rabbits. The method followed was as per the guideline of OECD N° 405 (April 2002).

Three healthy, adult albino male rabbits of the New Zealand White strain were selected for the study. Initially one rabbit was tested. Based on the results obtained at the 24 h post instillation observation, the irritation response was confirmed by testing two additional rabbits simultaneously. A volume of 0.1 mL of d-Phenothrin was instilled into one eye of each rabbit. The contralateral eye served as the control and was instilled with 0.1 mL of normal saline. Observations were made following the method provided by the guideline at 1 hour (on day 0), 24, 48 and 72 hours.

The mean eye irritation scores (following grading at 24, 48 and 72 hours post instillation) of the corneal opacity (0.00), iritis (0.00), redness (0.00) and chemosis (0.00) were not significant in the tested rabbits.

Accordingly, d-Phenothrin was not classified as eye irritant according to GHS / CLP (Regulation EC No 1272/2008)