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Carcinogenicity

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Description of key information

No carcinogenicity study per se is available and one is not scientifically justified.

Early investigations summarized in the specific investigations section evaluating the potential of initiation/promotion and tumor formation following skin painting and S.C. injection have been summarized by IARC in Monograph 71 as follows.

"Lauroyl peroxide was tested for carcinogenicity by subcutaneous administration in mice and rats and by skin application in mice. In one study in mice by subcutaneous administration, the evidence concerning a carcinogenic effect was inconclusive; in two other studies, no increase in tumour incidence was observed. Two studies in mice by skin application were inadequate for an evaluation of complete carcinogenicity; one study indicated that lauroyl peroxide has promoting activity in mouse skin (IARC, 1985)."

In addition, dilauroyl peroxide was not mutagenic and did not induce chromosomal aberrations in a number of in vitro assays. In addition, there were no effects reported in a 28-day repeat dose study. A 90-day repeat dose study did not reveal adverse effects up to the highest dose level tested, 1000 mg/kg/day.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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

Justification for classification or non-classification

No carcinogenicity study per se is available and one is not scientifically justified.

Early investigations summarized in the specific investigations section evaluating the potential of initiation/promotion and tumor formation following skin painting and S.C. injection have been summarized by IARC in Monograph 71 as follows.

"Lauroyl peroxide was tested for carcinogenicity by subcutaneous administration in mice and rats and by skin application in mice. In one study in mice by subcutaneous administration, the evidence concerning a carcinogenic effect was inconclusive; in two other studies, no increase in tumour incidence was observed. Two studies in mice by skin application were inadequate for an evaluation of complete carcinogenicity; one study indicated that lauroyl peroxide has promoting activity in mouse skin (IARC, 1985)."

In addition, dilauroyl peroxide was not mutagenic and did not induce chromosomal aberrations in a number of in vitro assays. In addition, there were no effects reported in a 28-day repeat dose study. A 90-day repeat dose study did not reveal adverse effects up to the highest dose level tested, 1000 mg/kg/day.

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