Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study similar to guideline with minor restrictions and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

six rabbits were used, whereas the left flank was only clipped, the right flank was additionally abraded, at each flank two patches were applied, no observation was performed at 1 and at 48 h

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

EC Number:

932-389-6

Molecular formula:

C23H19ClF3NO3

IUPAC Name:

Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd., Wyton, Huntingdon, Cambridgeshire, UK
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in aluminium sheet cages
- Diet (e.g. ad libitum): Labsure CRB ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimum 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 50-60%

Test system

Type of coverage:

occlusive

Preparation of test site:

other: left flank: clipped; right flank: clipped and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL per application site (two application sites per flank)

Duration of treatment / exposure:

24 h

Observation period:

at 24 and 72 h after start of application

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: left and right flank
- Type of wrap if used: the test item was covered by a surgical gauze patch, wrapped with a piece of rubber sheeting and secured with adhesive polyethylene tape

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

SCORING SYSTEM:
Scoring was performed according to Draize (Erythema score 0-4, Edema score 0-4).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 2 animals

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: intact skin, one animal was killed in extremis, three animals could not be evaluated du to brown stained skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 2 animals

Time point:

72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin, one animal was killed in extremis

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 5 animals

Time point:

24 h

Score:

1.4

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin, one animal was killed in extremis

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 5 animals

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: intact skin, one animal was killed in extremis

Irritant / corrosive response data:

Single application of cyhalothrin to rabbit skin caused brown staining which obscured erythema in three animals. In the remaining the test item caused only very slight or no erythema to both intact or abraded skin after 24h. After 72 h erythema had disappeared in all but one animal.
Edema were slight in all animals at 24 h and were fully reversible within 72 h.

Other effects:

One animal showed severe signs of toxicity such as subdued appearance, piloerection, severe ataxia, and increased depth of respiration. This animal was killed in extremis at 18 h.
Clinical signs in the other animals included slight ataxia, increased depth of respiration, subdued appearance and increased abdominal tone.

Any other information on results incl. tables

Table 1: Individual animal data of rabbits treated with cyhalothrin (intact skin)

Animal No.	Erythema				Edema
	24 h		72 h		24 h		72 h
	Patch 1	Patch 2	Patch 1	Patch 2	Patch 1	Patch 2	Patch 1	Patch 2
1	*	*	0	0	2	2	0	0
2	animal killed in extremis at 18 h due to severity of systemic effects
3	0	0	0	0	2	2	0	0
4	*	*	0	0	2	2	0	0
5	1	1	1	0	1	1	0	0
6	*	*	0	0	0	0	0	0

* Skin stained brown and obscured evaluation of erythema.

 

Table 2: Individual animal data of rabbits treated with cyhalothrin (abraded skin)

Animal No.	Erythema				Edema
	24 h		72 h		24 h		72 h
	Patch 1	Patch 2	Patch 1	Patch 2	Patch 1	Patch 2	Patch 1	Patch 2
1	*	*	0	0	2	2	0	0
2	animal killed in extremis at 18 h due to severity of systemic effects
3	0	0	0	0	2	2	0	0
4	*	*	0	0	2	2	0	0
5	1	0	0	0	1	1	0	0
6	*	*	0	0	1	1	0	0

* Skin stained brown and obscured evaluation of erythema.

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study is considered to be reliable with restrictions.

Executive summary:

Skin irritating properties of cyhalothrin were assessed in a Draize test similar to OECD Guideline 404 with slight deviations: 6 animals were used instead of 3, additionally to the clipped left flank the right flank was clipped and abraded with a scalpel, and two patches were applied per application site (left and right flank). GLP compliance was stated.

Single application of cyhalothrin to rabbit skin caused no or very slight erythema and very slight to slight edema to both intact and abraded skin at 24 h. Nearly all effects were fully reversible within 72 h. Mean erythema scores were 0.5 and 0.1 at 24 and 72 h, respectively. Corresponding edema scores were 1.4 and 0.0.

One animal showed severe signs of toxicity and was killed in extremis at 18 h. Clinical signs in the other animals included slight ataxia, increased depth of respiration, subdued appearance and increased abdominal tone.

Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the test item has not to be classified as skin irritant.