Executive Summary
Human Health
With dermal and oral LD50 values of > 2000 and e 4900 mg/kg bw, respectively, the acute toxicity of cocamidopropyl betaine is very low. About 30% active formulations are irritating to the skin and the eyes, while d 10 % active solutions caused only mild skin and eye reactions. From subacute and subchronic studies with rats a NOAEL of 1000 mg/kg bw/day for systemic toxicity of the 30% active CAPB was derived. Cocamidopropyl betaine gave no indication for genotoxic or teratogenic effects. Contact allergy to CAPB has been reported although extensive data now suggests that impurities in the final product are responsible for causing this skin sensitization.
Relevant consumer scenarios were described for the usage of household detergent products containing cocamidopropyl betaine and the resulting Margin of Exposures (MOE) were calculated comparing the systemic NOAEL to the estimated exposure values. For each scenario the MOE was above 104 (with the exception of one, which had a MOE of 7700 pre-treatment of clothes), which represents a very high safety margin. Also the estimation of the total consumer exposure resulted in a MOE of about 2800 which is also a high value. No risk is calculated for potential uptake via drinking water or food.
Acute toxic effects after unintentional oral exposure of a few millilitres of the formulations (1 30% concentration) are not to be expected. Neat CAPB is an irritant to skin and eyes. The irritation potential of aqueous solutions of CAPB depends on concentration. Local effects of hand wash solutions containing CAPB do not cause concern given that the concentrations of CAPB in such solutions are well below 1% and therefore not expected to be irritating to eye or skin. Laundry pre-treatment tasks, which may translate into brief hand skin contact with higher concentrations of CAPB, may occasionally result in mild irritation easily avoided by prompt rinsing of the hands in water. Potential irritation of the respiratory tract is not a concern given the very low levels of airborne CAPB generated as a consequence of cleaning sprays aerosols. Immediate eye rinsing with water for several minutes is recommended after accidental splashing of CAPB solutions, as eye irritation reactions may occur.
In view of the available database on toxic effects, the low exposure values calculated and the resulting large Margin of Exposure described above, it can be concluded that use of CAPB in household laundry and cleaning products raises no safety concerns for the consumers.
Environment
The environmental risk assessment will be published in a single comprehensive document on a later date at www.heraproject.com.
Hera Comments
Based on the data available in 2005, it was not possible to finalise the HERA report on environmental risk assessment. A REACH registration dossier was submitted in November 2010 and more information on cocamidopropyl betaine is available under ECHA website.