Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A two-generation reproduction toxicity study is waived, as the 90-days oral repeated dose toxicity study (NOEAL 1000 mg/kg bw/d) did not indicate adverse effects on reproductive organs or tissues. An OECD 421 reproduction/development screening study was waived as data from an OECD 414 teratogenicity study were available.


Short description of key information:
A two-generation reproduction toxicity study is waived as the 90-days oral repeated dose toxicity studies did not indicate adverse effects on reproductive organs or tissues.

Effects on developmental toxicity

Description of key information
An OECD 414 developmental toxicity study with the rat via the oral route revealed a NOAEL of 1000 mg/kg bw/d was reported. The NOAEL value correspond to the highest dose level tested.. 
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The effects of butyl methoxydibenzoylmethane (BMDBM) on developmental toxicity were assessed in one study similar to OECD 414 with the rats. Test item was applied orally to pregnant females during organogenesis. No effect on litter size was noticed up to the highest tested concentration of 1000 mg/kg bw/d (rat). This value was therefore considered as NOAEL. The NOAEL of 1000 mg/kg bw/ as derived from the study with the rat shall be used as key value for chemical safety assessment.


Justification for selection of Effect on developmental toxicity: via oral route:
Comparable to guideline study under GLP, minor restrictions.

Justification for classification or non-classification

One prenatal developmental toxicity study and in two repeated dose toxicity studies no effect on reproductive organs or on offspring development was observed, it can be concluded that BMDBM is not toxic to reproduction and therefore, no such classification is needed.