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EC number: 947-941-1 | CAS number: -
The substance is not irritating for intact and abraded rabbit skin.The substance is not irritating for rabbit eye.
Slight erythema and very slight to moderate oedeme was seen in 2/6 and 6/6 rabbits respectively, 24 hours after application of the compound. Very slight oedema was still present on 1/6 abraded sites at 72 hours.
The substance has been tested for skin irritation according to the method "Hazardous Substances Regulations" under the U.S. federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). During the test 5 male and 1 female rabbits are tested with 10 g of test item on shaved and abraded skin after 24 hours of patch treatment. Under the conditions of the present experiment the substance was considered to be not irritant for rabbit skin.
A slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. Generally there was very little change by 24 hours and thereafter the reactions subsided slowly with 3/3 washed and 2/3 unwashed eyes returning to normal as follows:- 72 hours (2/3 washed eyes), 6 days (1/3 washed eyes) and 10 days (2/3 unwashed eyes). The remaining unwashed eye still showed a very slight reaction at the termination of the study on day 14. Staining of the conjunctivae by the compound was seen in all eyes for up to 48 hours in the washed eyes, 10 days for 2/3 unwashed eyes and the duration for the remaining eye.
A slight corneal reaction consisting of slight opacity and damage to the surface epithelium was seen in 2/3 unwashed eyes at 24 and 48 hours. Staining of the cornea by the compound was also seen in the unwashed eyes for up to 10 days for 2/3 and the duration for the remaining one.
The substance has been tested for eye irritation according to The method "Hazardous Substances Regulations" under the U.S. federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965). During the test 5 male and 1 female rabbits are treated with 100 mg of the test compound. After 14 days only one animal (n. 13) showed a redness score (1), nevertheless in order to evaluate the irritation potential of the test item this animal was not considerd because his eyes were not rinsed after application.
The substance is considered to be not irritant for rabbit eyes.
Test on skin and eye irritation are available on similar substance 1. The complete hypothesis and justification for the read across approach has been attached in section 13.
Skin irritation assessment:
The assessment was based on single study (Huntsman, 1975) according to the method of the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). During the study only one rabbit shows a signs of erythema on intact skin. Oedema formation was recorded with 4 rabbits from very slight to slight, but all signs of irritation are fully recovered within 72 hours.
No animal showed a mean value for erythema or edema reaction ≥ 2.3
Eye irritation assessment:
The assessment was based on single study (Huntsman, 1975) irritation according to the method of the U.S. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965). During the study 5 male and 1 female rabbits were exposed to test article instilled into the conjunctival sac. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits for one minute with warm water. At the end of the observation period (14 days) all the irritation effect were fully reversible except for one rabbit that showed a residual redness score (1).
Considering that the eye of the animal was not rinsed and the observation period has a duration of 14 days instead of 21 as reported in the CLP Regulation (EC n. 1272/2008), the score was not considered for the evaluation of the irritation potential according the CLP Regulation.
No animal showed a mean value ≥ 1 for corneal opacity, ≥ 2 for conjunctival redness or ≥ 2 for conjunctival opacity
According to the CLP Regulation (EC n. 1272/2008), skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
The substance shows a very low interaction between with the rabbit skin. The values of erythema and oedema are below the trigger values for classification, therefore no classification is warranted according to the CLP Regulation (EC n. 1272/2008).
According to the CLP Regulation (EC n. 1272/2008) eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
The substance does not show eye effects with values above the trigger value for the classification. therfore the substance is not classified according to the CLP Regulation (EC n. 1272/2008).
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