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Administrative data

Description of key information

In an acute oral toxicity study with the rat the LD50 of BMDBM was greater than 16000 mg/kg bw . No dermal toxicity effects up to the maximum applied dose of 1000 mg/kg b were observed in an acute dermal toxicity study with the rat. No study on inhalation toxicity of BMDBM is available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Evaluating the study of Buser (1980) it is visible that acute oral toxicity of butyl methoxydibenzoylmethane (BMDBM) is of no concern as none of the tested animal died after oral application of the extraordinarily high dose of 16000 mg/kg bw. Clinical signs included lethargy and hunched posture. Body weights and gross necropsy were in normal limits.

Acute dermal toxicity was tested up to a dose of 1000 mg/kg bw showing no deaths among test animals. Slight erythema were observed in treated animals but also in the vehicle control, assuming that the vehicle Carbitol has a slight irritant effect to skin.


Justification for selection of acute toxicity – oral endpoint
Comparable to guideline study with acceptable restrictions.

Justification for selection of acute toxicity – dermal endpoint
Comparable to guideline study with acceptable restrictions.

Justification for classification or non-classification

With an acute oral LD50 > 16000 mg/kg bw no classification applicable for test item BMDBM.

Concerning acute dermal toxicity, the test item was only tested up to a maximum cdose of 1000 mg/kg bw, whereas the regulatory cut-off level for classification according to Regulation (EC) No 1272/2008 (CLP) is 2000 mg/kg bw. However, as several dermal penetration studies (as summarized in section 7.1) have proven that dermal bioavailability of BMDBM is very low and does never exceed 5%, it can be concluded without reasonable doubt that BMDBM is hardly absorbed through human skin and therefore poses no concern for acute health effects after dermal application. In conclusion a classification as acute toxic by dermal exposure is not necessary.