Registration Dossier
Registration Dossier
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EC number: 942-590-0 | CAS number: -
Endpoint summary
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.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
