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Administrative data

Description of key information

The test material (approx. 95% act. ingr.) was not irritating to the rabbit's skin or to the rabbit's eye under the test conditions chosen.

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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation study

Key study

A skin irritation study was performed in accordance to the guideline of the United States Environmental Agency (EPA) 81 -5 to determine the irritancy potential of the test material (95% act. ingr.) to the skin of New Zealand White rabbits (3 females, 3 males). In contrast to the guideline, the duration of exposure was 24 h and the observation period 7 days in this study. Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm loaded with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 -hour application. The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the Draize evaluation sheme. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). The mean values of the recordings 24 to 72 hours after treatment for both erythema and edema were 0.66 for all individual animals.The effects were fully reversible within 72 hours.

Supporting study

The irritancy potential of the test material (17% act. ingr.) was determined in a skin irritation study in accordance to the guideline of the United States Environmental Agency (EPA) 81 -5. However, the duration of exposure was 24 h and the observation period 7 days. The study design was the same described before in the key study. Just as in the key study, the test compound erythema was not assessable due to intensive staining. Therefore, the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). The mean values of the recordings 24 to 72 hours after treatment for both erythema and edema were in the range of 0 - 0.66 for all individual animals. The effect was fully reversible within 7 days. However, erythema and edema of animal 2 were not fully reversible within 7 days.Further time points would be necessary for evaluation.

Conclusion:

Based on these results, the test material (95% act. ingr.) is not irritating to the rabbit's skin under test conditions chosen.

Eye irritation study

Key study

A eye irritation study was performed in accordance to the guideline of the United States Environmental Agency (EPA) 81 -4 to determine the irritancy potential of the test material (approx. 95% act. ingr.) to the eyes of New Zealand White rabbits (3 males and 3 females). The test material in an amount of 0.1 mL was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline. Animals then were observed at the following time points: 1, 24, 48 and 72 hours following instillation and after 4 and 7 days. Irritation was scored in accordance to the guideline of the EPA. Concerning all individual animals which not received a washout, the mean cornea score (24/48/72 h) and iris score (24/48/72 h) was 0. The mean conjunctivae score (24/48/72 h) and chemosis score (24/48/72 h) was in the range of 0.66 - 1. The effects were fully reversible within 7 days.

Supporting study

The irritancy potential of the test material (17% act. ingr.) to the eyes of New Zealand White rabbits (3 males, 3 females) was examined in a eye irritation study according to the guideline of the EPA 81 -4. The study design was similar to the key study. The mean cornea score (24/48/72 h), the mean iris score (24/48/72 h) as well as the chemosis score (24/48/72 h) was 0 for all individual animals which not received a washout. The mean conjunctivae score (24/48/72 h) was 0.33.

Conclusion

Based on these results, the test material (95% act. ingr.) is not irritating to the rabbit's eye under test conditions chosen.

 

 


Justification for selection of skin irritation / corrosion endpoint:
This study used the test material which contains approx. 95% of the active ingredient.

Justification for selection of eye irritation endpoint:
This study used the test material which contains approx. 95% of the active ingredient.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

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