Registration Dossier

Administrative data

Description of key information

Based on available data for read-across source substances the test item is not considered to be a skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no experimental data available for the test item. Therefore, a read-across approach is applied with three source substances. For detailed information on the read-across apporach please refer to the read-across justification attached to IUCLID section 13. Furthermore, only key studies of the source substances are taken into account. For further supporting information please refer to respective dossier of each source substance.

CAS 121617 -08 -1

In a dermal sensitization study with 59.2% test substance in water, young adult guinea pigs (20 females in test group, 10 in control group) were tested using the method of Buehler according to OECD 406 (59.2% and 20% substance concentration in induction and challenge phase, respectively). As control vehicle (water) was used. As positive control material 2-Mercaptobenzothiazol was used and gave an adequate response.

The dermal application during induction phase I resulted after 30 hours in skin irritation in 11 out of 20 test animals consisting of very slight erythema, in 5 animals this additionally hardly noticeable oedema was observed. Further, occasionally dry skin, scaling and scratches at the application site were observed. Nine test animals and all control animals showed no skin irritation.

Thirty hours after application in induction phase II all test animals showed well-defined erythema and edema, and in 14 animals also dry skin was observed at the application site. The control animals showed no skin irritation.

At the shaving before the third induction application scaling of the skin at the application sites was observed in all test animals. Thirty hours after the third application all test animals showed well-defined to severe erythema and edema, in three animals associated with scaling, in eight animals with necrotic patches and three animals showed clear necrosis at the application site. The control animals showed no skin irritation.

The challenge with 20% test item resulted at 30 and 54 hours after application in a skin response in 2 out of 20 animals. The response consisted of very slight erythema and edema, and in one animal the edema was slightly increased after 54 hours. One control animal showed after 30 hours also a hardly visible red discoloration of the skin at the application site of the 20% test solution. The remaining animals (18 test animals and 9 control animals) showed no signs of irritation (erythema or edema) at the application site treated with 20% test solution.

The challenge with vehicle (water) did not result in a skin reaction at 18 test animals and all 10 control animals. One test animal showed hardly visible irritation of the skin after 30 hours, whereas another test animal showed this response after 54 hours.

For both the challenge with vehicle (water) as well as with 20% substance, 10% of the animals responded with light skin irritation. Therefore, the substance is considered to have no skin sensitization potential.

 

CAS 68411 -30 -3

A skin sensitization study with guinea pigs according to OECD 406 was conducted. 10 male and 10 female guinea pigs were given intradermal injections of 25% test solution. Control animals (5 male and 5 female) were given injections of vehicle only. One week later, a second induction was done by dermal exposure to 25% test solution for 24 hrs. Control animals were again exposed to vehicle only. On day 21, the challenge exposure was performed. All animals were exposed to 12.5% test solution dermally. Exposure was for 24 hrs, with observations made at 48 and 72 hrs after the start of exposure. No positive reactions were noted.

 

 

CAS 111 -42 -3

The sensitizing potential of the substance was investigated in a Maximisation test according to OECD TG 406 and EEC Directive 84/449 under GLP conditions in 40 female Himalayan Guinea pigs. Based on the reactions of a pre-test, a concentration of 5% was selected for intradermal injection, of 75% for epidermal induction and of 25% for epidermal challenge in the main study. The sensitivity of the test animals was confirmed at regular intervals using formaldehyde solution as positive control. No mortalities or toxic signs occurred. No positive skin reactions were evident after 1st challenge neither when treated with physiological saline nor with 25% DEA in the control group animals. In the test group 2/20 (10%) showed erythema findings at 24 h readings, declining to 1/20 (5%) at 48 h reading, when treated with 25% DEA. Thus, according to the general assessment criteria, no skin sensitizing potential of the test substance was noted in the Guinea pig maximization test.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data on three read-across substances are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. None of the three source substances is a skin sensitizer. As a result the test item is not considered to be classified as a skin sensitizer under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.