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

Endpoint summary

Description of key information

Skin Irritation, rabbit: not irritating (Jackson 1981)
Eye Irritation, rabbit: moderate irritant without irrigation; mid irritant with irrigation (Jackson 1981)
Respiratory irritation: no data

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin:

Two studies similar to guideline OECD 404 and under GLP.

Rabbit:

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.

Rat:

Skin irritating properties of cyhalothrin were assessed in a test on rats similar to OECD Guideline 404 with slight deviations: 6 rats were used to each of which 0.1 mL (instead of 0.5 mL) were applied. GLP compliance was stated.

Single application of cyhalothrin to rat skin under occlusive dressing for 24 h caused neither erythema nor edema but distinct signs of toxicity from day 3.

Eye:

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.

Effects on eye irritation: irritating

Justification for classification or non-classification

The available data on Skin Corrosion/Irritation are considered reliable with restrictions but adequate for the classification and labelling.

Based on the result, the substance does not meet the criteria for classification under the Directive 2001/59/EC, Annex VI, 3.2.6.1. as well as the criteria in the Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2.2.

The available data on Eye Irritation is considered reliable with restrictions but suitable for classification and labelling.

Based on the result, the substance has to be classified as eye irritant category II (reversible eye effects) under Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.3.2.

According to the criteria in Directive 2001/59/EC, Annex VI, 3.2, the substance is classified as R36, Irritating to eye.