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

Endpoint summary

Description of key information

Read across from sodium salt, sodium β-Alanine, N-C8-18-alkyl derivs. EC 305-318-6
The oral LD50 study on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 has reliability rating 2 and the procedure used meets the requirements of the limit test for acute oral toxicity described by the OECD Guideline 401. The results of this GLP compliant study indic
ate that the test material has little toxic effect when administered as a single oral dose to the rat at a dose level of 5000 mg/kg bw. The test material used consists of 40% active ingredient and 60% water. As the oral LD50 of the product is > 5000 mg/kg bw, the LD50 of the active ingredient is considered to be > 2000 mg/kg bw. 
The dermal LD50 study (OECD Guideline 402) on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 is performed according to GLP and has reliability rating 1. It is therefore considered acceptable for classification and labelling purposes. The LD50 of the active ingredient is considered to be > 2000 mg/kg bw, and it does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Two acute studies are available onSodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, one on acute oral toxicity and one on acute dermal toxicity.

 

The oral LD50 study on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 has reliability rating 2 and the procedure used meets the requirements of the limit test for acute oral toxicity described by the OECD Guideline 401. The reliability rating of 2 is based on the fact that there is no information on batch number or composition of the substance within the report. Internal data on composition is available, and the result from this study is considered to give a true evaluation of the acute oral toxicity potential of the substance. The results of this GLP compliant study indicate that the test material has little toxic effect when administered as a single oral dose to the rat at a dose level of 5000 mg/kg bw. The test material used consists of 40% active ingredient and 60% water. As the oral LD50 of the product is > 5000 mg/kg bw, the LD50 of the active ingredient is considered to be > 2000 mg/kg bw.

The dermal LD50 study (OECD Guideline 402) on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 is performed in 2012 according to GLP and has reliability rating 1. It is therefore considered reliable to use for classification and labelling purposes. The LD50 of the active ingredient is considered to be > 2000 mg/kg bw, and it does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity

 

Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate), CAS 94441-92-6 it 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 the low potential for inhalation exposure means this is not required.

Justification for selection of acute toxicity – oral endpoint
Read across from sodium salt, sodium β-Alanine, N-C8-18-alkyl derivs. EC 305-318-6
The available study on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, is acceptable for classification and labelling purposes being of Klimisch 2 validity. The LD50 of the active ingredient is considered to be > 2000 mg/kg bw, and it is classified as Category V, according to Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011).

Justification for selection of acute toxicity – inhalation endpoint
Read across from sodium salt, sodium β-Alanine, N-C8-18-alkyl derivs. EC 305-318-6
No inhalation LC50 data is available for Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate), CAS 94441-92-6, however it is a paste with a low vapour pressure of 1.5 mPa at 20°C, significant exposure to vapours would not be expected at ambient temperatures so the lack of an inhalation LD50 is not considered significant as inhalation is not an expected route of exposure.

Justification for selection of acute toxicity – dermal endpoint
Read across from sodium salt, sodium β-Alanine, N-C8-18-alkyl derivs. EC 305-318-6
The available study on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, is acceptable for classification and labelling purposes being of Klimisch 1 validity. The LD50 of the active ingredient is considered to be > 2000 mg/kg bw, and it does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), nor the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

Justification for classification or non-classification

Although the acute oral study has a reliability of 2, it is considered to be correct and based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate), CAS 94441-92-6 does not have to be classified and labeled with respect to acute oral toxicity in the rat.

 

Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate), CAS 94441-92-6 does not have to be classified and labeled with respect to acute dermal toxicity in the rat.