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Administrative data

Description of key information

Overall, studies of HPMA in experimental animals and case reports in workers have provided only equivocal to weak evidence of sensitization potential. Nonetheless, for purposes of classification and labeling, HPMA should be considered to have skin sensitization potential.

HPMA is not expected to cause respiratory sensitisation.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

HPMA has been evaluated for skin sensitization potential in tests in experimental animals. Studies in which HPMA was applied only to intact skin elicited only equivocal or non-sensitizing responses (Scholes et al, 1992; Rao et al, 1981). However, a few animals were sensitized using the Magnusson-Kligman protocol as reported by (Bjorkner, 1984; Clemmensen, 1984, Basketter and Scholes, 1992) and the response was judged to be equivocal. 

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On balance for HPMA, slightly to mild sensitizing potential was demonstrated in two of three maximization studies in guinea pigs and a round robin study in the local lymph node assay supported a conclusion of equivocal results.  Sensitizing potential has not been clearly demonstrated in humans. Many workers related to dentistry suffered allergic contact dermatitis; however, the agent that caused sensitization was not identified, nor was it possible to distinguish between concomitant sensitization and cross reactivity.

 

 

 


Migrated from Short description of key information:
Overall, studies of HPMA in experimental animals and case reports in workers have provided only equivocal to weak evidence of sensitization potential. Nonetheless, for purposes of classification and labeling, HPMA should be considered to have skin sensitization potential.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Although HPMA has been reported to cause skin sensitisation in experimental animals and in humans, it is not expected to cause respiratory sensitisation. Methyl methacrylate, a close structural analogue of HPMA, has been extensively evaluated for potential to cause respiratory sensitisation; there are no data in experimental animals or in humans to indicate that MMA is a respiratory sensitiser.


Justification for classification or non-classification

Overall, studies of HPMA in experimental animals and case reports in workers have provided only equivocal to weak evidence of sensitization potential. Nonetheless, for purposes of classification and labeling, HPMA should be considered to have skin sensitization potential.

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