Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

No experimental data on sodium acrylate are available. Data on the structural analogue acrylic acid which has been extensively studied, are included for assessment.

 

Acrylic acid was tested in guinea pigs using a modified Split Adjuvant Test procedure. The highest concentration which did not cause primary irritation was used but no data were given on the test concentrations. Ten animals per test received a 0.1 ml aliquot of acrylic acid to the backs four times in 10 days. At the time of the third application, 0.2 ml Freund's adjuvant was injected at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challenged with the test material on one flank and a solvent (if used) on the other flank. The challenge site was evaluated for erythema and oedema at 24 and 48 hours. Acrylic acid was negative (0/10) (Rao et al. 1981).

 

Van der Walle et al.(1982) reported a sample of commercial grade acrylic acid to be sensitizing in a Freund’s Complete Adjuvant test. 8/8 guinea pigs were sensitized. However, analysis by gas chromatography revealed an impurity of 45 % in this sample. The sample of acrylic acid was distilled in vacuo and the sensitized animals were tested with the distillate (containing >98% acrylic acid) and with the residue. None of the animals reacted to the distillate but all the animals reacted to the residue. The identity of the allergen in this residue was under investigation at the time of publication of this paper.

 

In a modified Freund's Complete Adjuvant test 8 guinea pigs/group received 3 intradermal injections during the induction phase on days 0, 5 and 9 (the test substance was mixed with FCA in a volume of 0.1 ml). Non-irritant test concentrations were used for challenge at day 21. The test concentrations for intradermal injections were 3 x 0,17 M (1.2%) in water and for challenge 1 and 0.3 M in Aramek, a mixture of 2 parts methyl ethyl ketone and 1 part of peanut oil. Distilled acrylic acid was negative but commercial acrylic acid proved to be a strong skin sensitizer. The skin reactions were due to the presence of varying quantities (up to 7%) of a,ß-diacryloxypropionic acid (DAPA). Positive skin reactions were still present after a third challenge on day 49 (Waegemakers and Van der Walle 1984).

 

Based on the presented data, acrylic acid does not have a skin sensitizing potential in animal studies. Positive test results obtained with commercial grade samples of the compound were caused by the presence of the impurity DAPA.

Based on the structural similiarites of acrylic acid and sodium acrylate it is anticipated that sodium acrylate will not cause skin sensitisation in animals.

 

 


Migrated from Short description of key information:
Based on its structure and data from the structural analogue acrylic acid, sodium acrylate does not have a potential to cause skin sensitization in animals or humans.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
There is no information available on the potential of sodium acrylate to produce respiratory sensitization in animals or humans. Based on its physico-chemical properties (extremely low vapour pressure and solid substance), respiratory sensitization in humans is estimated to be very unlikely.

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.3, 2009): no classification required