Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key 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 (EU RAR of sodium hydroxide (2007), section 4.1.2.8, page 73). It can be concluded that a specific study to determine the toxicity to reproduction is not necessary.
Additional information

No valid studies were identified regarding developmental toxicity nor toxicity to reproduction in animals after oral, dermal or inhalation exposure to NaOH (EU RAR, section 4.1.2.8, page 73).

It is not useful to do a reproduction or developmental toxicity test with NaOH in rats because the hazard of sodium for humans has been characterised sufficiently (e.g. Fodor et al., 1999). It is also not useful to study the reproduction/developmental toxicity of hydroxide via an oral study because at high concentrations the substance is corrosive or irritating, while at low concentrations the hydroxide will be neutralised in the stomach by gastric juice, which has a very low pH. Furthermore, oral exposure to NaOH is negligible under normal handling and use condtions and therefore an oral reproduction/developmental toxicity study is inappropriate.

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 necessary.


Short description of key 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 (EU RAR of sodium hydroxide (2007), section 4.1.2.8, page 73). It can be concluded that a specific study to determine the developmental toxicity or the toxicity to reproduction is not necessary.

Effects on developmental toxicity

Description of key 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 (EU RAR of sodium hydroxide (2007), section 4.1.2.8, page 73). It can be concluded that a specific study to determine the developmental toxicity or the toxicity to reproduction is not necessary.

Justification for classification or non-classification

Classification for reproductive or developmental toxicity is not necessary since NaOH is not expected to be systemically available in the body under normal handling and use conditions and the substance will not reach the foetus nor reach male and female reproductive organs (EU RAR of sodium hydroxide (2007), section 4.1.2.8, page 73).

Additional information