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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

nine rabbits were used, in three of them the test item was washed out 20 seconds after instillation, scoring was performed according to Kay and Calandra

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill, Abbotts Ripton Rd., Wyton, Nr Huntingdon, Cambridgeshire, UK
- Age at study initiation: 77-119 d
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in aluminium sheet cages (605x490x455 mm)
- Diet (e.g. ad libitum): Labsure CRB Rabbit Diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1°C
- Humidity (%): approximately 65%
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL undiluted test material

Duration of treatment / exposure:

6/9 animals: the test item was not removed
3/9 animals: the test item was washed out 20 seconds after instillation

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

9 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of 9 animals, the test item was washed out with lukewarm tap water for 1 minute
- Time after start of exposure: 20 seconds after instillation

SCORING SYSTEM:
Eye effects: according to Kay JH, Calandra JC, J Soc Cosmet Chem. 1962, 13:6
Pain: 5 stage scoring system
0 - No pain (No response)
1 - Practically no initial pain (A few blinks only; normal within 1-2 min)
2 - Slight initial pain (Rabbit blinks and tries to open eye, but the reflex closes it)
3 - Moderate initial pain (Rabbit holds eye shut and puts pressure on lids; may rub eye with paw)
4 - Severe initial pain (Rabbit holds eye shut vigorously; may squeal)
5 - Very severe initial pain (Rabbit holds eye shut vigorously; may squeal, claw at eye, jump and try to escape)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 1-2h

Score:

26

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

24 h

Score:

24

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

48 h

Score:

11

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

72 h

Score:

9

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: day 4

Score:

4

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

7 d

Score:

0

Max. score:

110

Reversibility:

fully reversible

Results 7

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1-2h

Score:

29

Max. score:

110

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: irrigation group

Results 8

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

24 h

Score:

19

Max. score:

110

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: irrigation group

Results 9

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

48 h

Score:

3

Max. score:

110

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: irrigation group

Results 10

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

72 h

Score:

0

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

other: irrigation group

Irritant / corrosive response data:

Conjunctivitis, corneal opacity and iritis were observed in all animals but were fully reversible within 7 days. Conjunctivitis, corneal opacity and iritis were noticeably less prominent in rabbits receiving irrigation with water and were also fully reversible within 3 days. Many of the animals showed signs of convoluted and sensitive eyelids. In some animals the lids were thickened with crusting from the discharge early in the study. However, none of these abnormalities was observed at day 7.

Other effects:

Instillation of cyhalothrin into the rabbit eye caused practically no initial pain in seven animals and slight to moderate initial pain in the other two (1-2/3 on a 0-5 scale).

Any other information on results incl. tables

Table 1: Mean eye irritation scores after cyhalothrin instillation in the rabbit eye (unwashed)

	Max score	Group mean score
		1-2 h	day 1	day 2	day 3	day 4	day 7
Cornea	80	8	10	5	5	2	0
Iris	10	4	3	2	1	1	0
Conjunctiva	20	14	11	4	3	1	0
Total	110	26	24	11	9	4	0

Values are means of 6 animals and rounded to the nearest whole number

 

Table 2: Mean eye irritation scores after cyhalothrin instillation in the rabbit eye (washed out after 20 sec)

	Max score	Group mean score
		1-2 h	day 1	day 2	day 3	day 4	day 7
Cornea	80	10	7	0	0	0	0
Iris	10	5	3	0	0	0	0
Conjunctiva	20	14	9	3	0	0	0
Total	110	29	19	3	0	0	0

Values are means of 3 animals and rounded to the nearest whole number

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The study is considered to be reliable with restrictions.

Executive summary:

The eye irritating properties of cyhalothrin were assessed in an in vivo test similar to OECD Guideline 405 with slight modifications and under GLP. The scoring of eye effects was performed according to Kay and Calandra. In three rabbits, the test item was removed 20 seconds after instillation by irrigation with water.

Conjunctivitis, corneal opacity and iritis were observed in all animals but were fully reversible within 7 days. Conjunctivitis, corneal opacity and iritis were noticeably less prominent in rabbits receiving irrigation with water and were fully reversible within 3 days. Convoluted and sensitive eyelids were observed in many animals as well as thickened lids with crusting from discharge.