Registration Dossier

Administrative data

Description of key information

Eye irritation: Not irritating (based on result of 1 key study)
Skin irritation: Category 2: Irritant (based on a weight of evidence approach from 4 studies)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Eye irritation:

The test article as a 6% w/v concentration in propylene glycol (0.1 ml) was applied to right eyes of 6 rabbits. Eyes were examined before testing and at 24, 48 and 72 hours and at 4 and 7 days. The irritation was scored by the method of Draize. Based on the classification criteria according to CLP Regulation (EC) no. 1272/2008 whererby 6 rabbits have been used in the study the substance is not considered to be classified.

Skin irritation:

4 studies have been conducted in total

Study conducted with 3 animals:

In study 307-338/8403 0.5 ml of test material was applied semiocclusively to the skin of 3 rabbits for 4 hrs. Observations of skin reactions were observed at 1 hour, 24, 48, 72 hours and at 7 days. Based on the classification criteria set out in accordance with CLP Regulation (EC) no. 1272/2008 the test material is considered to be a category 2 irritant.

 

Studies conducted with 4 animals:

In study 70-101/8503 0.5 ml of test material was applied semiocclusively to the skin of 4 rabbits for 4 hrs. Observations of skin reactions were observed at 1 hour, 24, 48, 72 hours and at 7 days.

 

In study 150-173/8602 0.5 ml of test material was applied semiocclusively to the skin of 4 rabbits for 4 hrs, at concentrations of 100% and 50 %. Skin reactions were recorded after 1 hour, 24, 48, 72 hours and 7 days.

 

In study 53-64/8607 0.5 ml of test material was applied semiocclusively to the skin of 4 rabbits for 4 hrs, at concentrations of 100%, 50 %, 25 %, 10 %. Skin reactions were recorded after 1 hour, 24, 48, 72 hours and 7 days.

 

Whereby 4 animals rather than 3 animals are used in the study the criteria within the Guidance on the Application of the CLP Criteria section 3.2.2.3.2.2 In vivo data, subsection entitled "Tests that have been conducted with more than three animals" applies.

 

That specifies two methods for determining the conclusion:

Method 1: The overall average over all animals will be used.

Method 2: According to the second approach the average score is determined per animal ie Skin Irritant Category 2 is assigned if at least in 3 individuals the mean score exceeds the value of 2.3. 

The more stringent result has to be used if the evaluation according to the first method is different to that of the second method.

  

In study 70-101/8503 according to the first method of evaluation, the arithmetic mean after 24/48/72 hours for erythema ME= 24:12 = 2 and for oedema MO= 26:12 = 2.2. Both values are <2.3 therefore result is considered slightly irritating.

According to the second method a mean value of <2.3 was obtained for erythema in all animals and >2.3 for oedema in 2 animals therefore the result is considered to be negative. As both results are negative using the 2 methods in accordance with this study the substance does not need to be classified.

 

In study 150-173/8602 the results obtained from the 100% solution are used for evaluation. According to the first method of evaluation, the arithmetic mean after 24/48/72 hours for erythema ME= 26/12 = 2.2 and for oedema MO= 32:12 = 2.67. As the result for oedema is >2.3 the result is considered positive.

According to the second method a mean value of >2.3 was observed in 1 of the 4 animals for erythema and in 3 of the animals for oedema therefore the result is considered positive. Both results are positive and the substance should be classified as a Cat 2 skin irritant.

  

In study 53-64/8607 the results obtained from the 100% solution are used for evaluation. According to the first method of evaluation, the arithmetic mean after 24/48/72 hours for erythema ME= 24/12 = 2 and for oedema MO= 17:12 = 1.5. Both values are <2.3 therefore the result is considered negative.

According to the second method a mean value of <2.3 was observed in all animals for both erythema and oedema. As both results are negative using the 2 methods in accordance with this study the substance does not need to be classified.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Eye irritation:

Based on the classification criteria set out in accordance with CLP Regulation (EC) no. 1272/2008 the test material is not considered to be an eye irritant.

Skin irritation:

Two of the four studies resulted in no classification and the other two resulted in a Category 2: Irritant classification. In this case the conservative apporach is taken and the substance should be classified as a Category 2: irritant.