β-Alanine, N-C8-18-alkyl derivs., monopotassium salts

Endpoint summary

Description of key information

Skin irritation (in vivo): not irritating (OECD 404)
In the skin irritation /corrosion key study the Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, was applied to the shorn skin of 3 (female) New Zealand White albino rabbits at a dose of 0.5 mL under semi-occlusive dressing during 4 hours. No cutaneous reactions (erythema or oedema) were observed up to 72 hours after the exposure. Based on these results, the test substance was considered to be not irritating, under the conditions of this study, in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
Eye irritation (in vivo): not irritating (OECD 405)
In the eye irritation key study three male albino New Zealand White rabbits were administered a single ocular dose of 0.1 ml of the test substance and observed up to eight days after instillation. Moderate conjunctiva reactions (redness and chemosis) were observed, which were totally reversible within 8 days. Based on these results, the test item was considered not to be irritating to the eyes, under the conditions of this study, in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC. 

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
Three in vivo skin irritation studies are availableon Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, which were all performed according to OECD 404 and under GLP conditions. In the key study the test material was applied to the shorn skin of 3 (female) New Zealand White albino rabbits at a dose of 0.5 mL under semi-occlusive dressing during 4 hours. No cutaneous reactions (erythema or oedema) were observed up to 72 hours after the exposure. Based on these results, the test substance was considered to be not irritating, under the conditions of this study, in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC. The results of the key study were in agreement with the results of the two supporting studies.

Eye 

Two in vivo eye irritation studies are available onSodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6. Both were both performed according to OECD 405 and under GLP conditions. In the key study three male albino New Zealand White rabbits were administered a single ocular dose of 0.1 ml of the test substance and observed up to eight days after instillation. Moderate conjunctiva reactions (redness and chemosis) were observed, which were totally reversible within 8 days. Based on these results, the test item was considered not to be irritating to the eyes, under the conditions of this study. The results of the key study were in agreement with the results of the supporting study. In the third study an alternative method the hen's egg chorioallantoic membrane test (CAM test) was used. There are some experimental difficulties with this test, the method is not validated, the test was not performed under GLP, the study is only limited reported and there is no information on batch and only limited information on composition of the substance. The reliability rating of this report is 4, not assignable and the study is therefore disregarded. Based on these results the test substance was not considered to be irritating to the eyes, under the conditions of this test.

Inhalation 

Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate) CAS 94441-92-6was not found to be irritating to neither skin or eye. This indicates that the substance is unlikely to cause any respiratory irritation.Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate), CAS 94441-92-6, is a paste with a low vapour pressure of 1.5 mPa at 20°C and therefore inhalation exposure is unlikely. Data on acute inhalation is lacking, but taking the result from the skin and eye irritation / corrosion studies and the low potential for inhalation exposure into consideration, the substance is not to be classified as a respiratory irritating substance in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.

Justification for selection of skin irritation / corrosion endpoint:
There are three skin irritation / corrosion studies available for Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6. Both the key and the two supporting studies were performed according to OECD 404 and under GLP conditions. The oldest supporting study is lacking information on batch number and composition, and is therefore considered to have reliability rating 2. The two newer studies have been given the reliability rating 1, and the most recent study was chosen as the key study. The results from the three studies coincide, and the substance is not classified as irritating to skin in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.

Justification for selection of eye irritation endpoint:
There are three eye irritation studies available for Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, two which are performed according to OECD 405 and under GLP conditions. These two studies are therefore given reliability 1, and the most recent study was chosen to be the key study, as in this study some (reversible) effects were observed. In the third study an alternative method, the hen's egg chorioallantoic membrane test (CAM test), was used. There are some experimental difficulties with this test, the method is not validated, the test was not performed under GLP, the study is only limited reported and there is no information on batch and only limited information on composition of the substance. The reliability rating of this report is 4, not assignable, and the study is therefore disregarded. The results from the two reliable studies coincide, and the substance is not classified as irritating to eye in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.

Justification for classification or non-classification

Skin

The conclusion from the three available studies is that the substanceSodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate), CAS 94441-92-6, is not to be classified according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 and is considered “not irritating” to skin.

 

Eye

The conclusion from the two available relevant studies is that the substanceSodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate) CAS 94441-92-6 is not classified according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 and is considered “not irritating” to eye.

 

Inhalation

Data on acute inhalation is lacking, but taken the result from the skin and eye irritation / corrosion studies and the low potential for inhalation exposure into consideration, the substance is not classified as a respiratory irritating substance in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.