Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
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.

A screening test following OECD 422 has been conducted on the similar substance Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified and reproductive parameters were unaffected by treatment up to 500 mg/kg/day (NOAEL)


Short description of key information:
NOAEL oral rat = 500 mg/Kg bw

Justification for selection of Effect on fertility via oral route:
GLP compliant with international guideline

Effects on developmental toxicity

Description of key information
NOAEL oral rat = 500 mg/Kg bw
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

In the reproduction/developmental toxicity screening test were not observed adverse effects on fertility and results are reasonably clear to exclude the suspect of any developmental toxicant effects; therefore there are no concerns to consider further investigations.

Justification for classification or non-classification

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