Cordierite (Mg2[Al4O3(SiO3)5])

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure

Justification for type of information:

In accordance with the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance (Version 4.0), the study does not need to be performed as no statically significant effects on reproductive organs and tissues nor concerns in relation with reproductive toxicity were identified on the substance and its analogues during the repeated dose toxicity studies nor the prenatal developmental toxicity studies. Moreover, in accordance with Annex IX of REACH, Column 2, taking into account the toxicokinetics profile of the substance, the systemic absorption following exposure by oral route is considered to be inconsequential.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified