Sodium butanolate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Since sodium butanolat was not tested because of its corrosiveness and waiving was done according to ANNEX VII column 2 of the REACH regulation for animal welfare reasons, the sensitizing potential was assessed by taking into acccount the sensitizing properties of one of the hydrolysis products NaOH:

NaOH:

Data on skin sensitisation were reported by Park et al (1995) (EU RAR, 2007; section 4.1.2.4, page 70). Male volunteers were exposed on the back to sodium hydroxide concentrations of 0.063-1.0% (induction). After 7 days the volunteers were challenged to a concentration of 0.125%. The irritant response correlated well with the concentration of NaOH, but an increased response was not observed when the previously patch tested sites were re-challenged.

Furthermore, NaOH has been used widely and for a long time and no human cases of skin sensitisation have been reported and therefore NaOH is not considered to be a skin sensitiser (EU RAR 2007).

Migrated from Short description of key information:
read across to NaOH: Based on a study with male volunteers sodium hydroxide has no skin sensitisation potential (Park et al., 1995).

Respiratory sensitisation

Endpoint conclusion

Additional information:

Existing data of the hydrolysis products of sodium butanolat (NaOH and n-Butanol) do not demonstrate any skin sensitizing properties.

Since hydrolysis of sodium butanolat occures immediately at air humidity, the properties of the hydolysis products can be used to derive its skin sensitizing potential. Therefore, sodium butanolate is considered not to be a skin sensitizer.