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Diss Factsheets

Administrative data

Description of key information

The test item should be considered as skin sensitiser Category 1B.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation

There are 7 studies available assessing the skin sensitising potential of the test item. Four of them indicate positive effects, 3 show no sensitisation effects and 1 study was disregarded due to unclear results. All studies are used in a weigth of evidence approach.

 

In the first study (1996) an LLNA test was performed with mice according to OECD and GLP. The test concentrations were 1, 10 and 30% and the pooled treatment group approach was used. 30% concentration of the test item elicited an SI of 4.95 and the response was consistent with a biological dose-response. Under the conditions of the test, the test item fulfilled the criteria for a potential sensitiser and should be considered as skin sensitising Category 1B.

The second study (1997_a: Company code 1996169) was also a Guinea Pig Maximization Test, performed according to OECD 406 and GLP. Induction was done with the undiluted test item, challenge was done with 100 and 25% and re-challenge was done with 12.5 and 5%. 14/20 guinea pigs showed positive reactions with 100% test item and 6/20 with 25% of the test item. No reactions were observed in the control group or during re-challenge. The positive reactions lead to classification of the substance as sensitising Category 1B.

 

The third supporting study (1997_b: Company code 1996170) was also a Guinea Pig Maximization Test according to OECD 406 and GLP. Induction was done with the undiluted test item, challenge was done with 100 and 25% and re-challenge was done with 12.5 and 5%. During the study 2 test animals died, however, this did not affect the purpose or integrity of the study.

16/18 guinea pigs showed positive reactions with 100% test item and 8/18 with 25% of the test item, resulting in more than 30% of the animals having positive reactions.

 

The fourth study (1984_a; Company code 1984026) was a Guinea Pig Maximization Test similar to OECD 406 and GLP. Induction was done with the undiluted test item and challenge and re-challenge was done with 25%. 6/20 guinea pigs showed scattered mild redness at the 24 hour reading and 7/20 at 48 hours, corresponding to 30 - 35% of the animals reacting positively.

These 4 studies clearly indicate that the substance should be classified as skin sensitizing Category 1B.

 

The remaining 3 studies do not confirm that the substance should be classified and will be discussed here.

 

The fifth study of (1984_b; Company code 1984028) was again a Guinea Pig Maximization Test, similar to OECD 406 and GLP. Induction was done with the undiluted test item and challenge was done with 25% of the test item. 20 animals were tested and none showed reactions to the test item neither at 24 nor at 48 hours.

 

The sixth study (1984_c; Company code 1984030) was another Guinea Pig Maximization Test similar to OECD 406 and GLP. Here, induction and challenge were done with the undiluted test item. Of the 20 animals in the test group none showed positive reactions to the test item neither at 24 hour nor at 48 hour. 

 

The seventh study (Neilson, 1993; Company code: 1992154) was a Human Repeat Insult Patch Test with 92 volunteers. Induction and challenge were done with 10% test item. Please note that this study is entered in section 7.10.4 of IUCLID. During the study 11 volunteers dropped out, therefore only 81 volunteers completed the test. Low levels of irritation were seen during induction and at challenge no skin sensitization reactions were observed.

 

In summary, 4 studies using 2 different methods indicate that the substance should be considered as a skin sensitiser Category 1B and 3 studies show negative results using the same method. Taking together all available data and using a worst case approach, the substance should be classified as skin sensitizing Category 1B.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation

In the Tables 3.4.3 and 3.4.4 of the CLP Regulation No 1272/2008 the criteria for skin sensitising are depicted for the various methods that can be used.

Following the criteria for LLNA, the substance should be classified as Category 1B based on the observation that the SI for 30% concentration is 4.95, which is > 2%.

The positive GPMT tests indicated that > 30% of the animals showed a positive reaction at concentrations > 1%, indicating that the substance should be classified as Category 1B, confirming the key result.