Registration Dossier

Administrative data

Description of key information

NOAEL oral rat = 30 mg/kg bw

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Good quality, good study, GLP compliant, on a similar substance

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For this endpoint, the read across between PWH/ammonium and PWH/sodium salt is valid, because this toxicological property is defined by the main component.The read across justification that takes into account the ammonium ion properties is attached on section 13 of the dossier.

An OECD 422 study has been conducted on Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified setting a NOAEL = 30 mg/Kg . The minimal effect concentration has been set at 180 mg/kg bw, that for a 422 repeated dose test is not leading to classification for repeated dose toxicity. No study has been conducted for inhalatory and dermal repeated dose toxicity because exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size and exposure of humans by dermal route is unlikely; physicochemical and toxicological properties don't suggest potential for a significant rate of absorption through the skin


Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans by dermal route is unlikely; physicochemical and toxicological properties don't suggest potential for a significant rate of absorption through the skin

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans by dermal route is unlikely; physicochemical and toxicological properties don't suggest potential for a significant rate of absorption through the skin

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) the substance is not classified for repeated dose toxicity.