Registration Dossier

Registration Dossier

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Administrative data

Description of key information

Read-across data captured from published Benzophenone registration dossier:

Oral rats and mice 2y (OECD Guideline 451): There was some evidence of carcinogenic activity of benzophenone in male rats based on increased incidences of renal tubule adenoma.

These neoplasms were accompanied by significantly increased incidences of renal tubule hyperplasia and are likely a consequence of chronic injury.

Mononuclear cell leukaemia in male rats was increased in the low and mid dose compared to the control group, but due to the lacking dose response a relation to treatment is considered unlikely by the registrant. There was equivocal evidence of carcinogenic activity of benzophenone in female rats based on the marginally increased incidences of mononuclear cell leukaemia, also lacking a dose response relationship, and histiocytic sarcoma.

Tumor incidencies

Males:
Kidney: renal tubule, adenoma (standard evaluation - 1/50, 1/50, 2/50, 4/50; standard and extended evaluations combined - 2/50, 2/50, 7/50, 8/50)
Equivocal findings: Mononuclear cell leukaemia: (27/50, 41/50, 39/50, 24/50)
Females:
Equivocal findings: Mononuclear cell leukaemia: (19/50, 25/50, 30/50, 29/50); Histiocytic sarcoma: (0/50, 0/50, 1/50, 2/50)
Decreased incidences: Mammary gland: fibroadenoma (27/50, 24/50, 15/50, 7/50)

(Unnamed study report, 2006).

Statement from IARC: sufficient (but no clear) evidence for the carcinogenicity in experimental animals and possibly carcinogenic to humans. As stated the mechanistic evidence for the tumour induction by BP is weak.


Key value for chemical safety assessment

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221. As a result the substance is considered to be not classified as carcinogen.

Additional information

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