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)

Endpoint summary

Description of key information

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.

The mean eye irritation scores (following grading at 24, 48 and 72 hours post instillation) was 0.0 as mean of corneal opacity (0.00), iritis (0.00), redness (0.00) and chemosis (0.00) in the tested rabbits and accordingly, d-Phenothrin was not classified as eye irritant according to GHS / CLP (Regulation EC No 1272/2008).

As in vivo studies for skin and eye irritation were available, further in vitro studies are not required.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002 version

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

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)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

A study was performed to assess the acute dermal skin irritation potential of d-Phenothrin in New Zealand White rabbits following guideline 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.

Eye:

A 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)

Justification for classification or non-classification

In studies according to OECD 404 and 405 no irritation of skin or eyes was seen upon exposure to d-Phenothrin and thus the substance is not subject to classification for skin or eye irritation according to CLP (Regulation EC No 1272/2008).