Registration Dossier

Administrative data

Description of key information

No carcinogenicity data were available specifically on POPDA. According to Annex X of REACH, a carcinogenicity study may be required if the substance has a widespread dispersive use or if there is evidence of frequent or long-term human exposure and the substance is classified as mutagen category 3 or if there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. Based on the available data, POPDA is not classified as a mutagen and there was no evidence of hyperplasia and/or pre-neoplastic lesions in a 90-day dermal toxicity study. Based on the weight of evidence, there are sufficient data to conclude that POPDA is not a carcinogen. Moreover, POPDA is not expected to have a widespread dispersive use.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No carcinogenicity data were available specifically on POPDA. According to Annex X of REACH, a carcinogenicity study may be required if the substance has a widespread dispersive use or if there is evidence of frequent or long-term human exposure and the substance is classified as mutagen category 3 or if there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. Based on the available data, POPDA is not classified as a mutagen and there was no evidence of hyperplasia and/or pre-neoplastic lesions in a 90-day dermal toxicity study. Based on the weight of evidence, there are sufficient data to conclude that POPDA is not a carcinogen. Moreover, POPDA is not expected to have a widespread dispersive use.

Justification for classification or non-classification