Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Data waiving:
study technically not feasible
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
other:
Justification for type of information:
NaOH is not expected to be systemically available in the body under normal handling and use conditions and for this reason it can be stated that the substance will not reach the foetus nor reach male and female reproductive organs. it can be concluded that a specific study to determine the developmental toxicity or the toxicity to reproduction is not technically feasible (EU RAR, 2007; section 4.1.2.8, page 73).

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hydroxide
EC Number:
215-185-5
EC Name:
Sodium hydroxide
Cas Number:
1310-73-2
Molecular formula:
HNaO
IUPAC Name:
sodium hydroxide

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion