Registration Dossier
Registration Dossier
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EC number: 942-590-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50 oral rat > 2000 mg/Kg bw
LD50 dermal rat > 2000 mg/Kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Good GLP study available on a similar substance
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Good GLP study available on a similar substance
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.
Two good GLP studies are available on a very similar substance, and both agreed in not showing any clinical sign and any toxicity at doses of 2000 mg/Kg bw for oral and dermal routes.
It can be assumed that the results will be the same also for Paraffin waxes and Hydrocarbon waxes, chloro, sulfochlorinated, saponified. Molecular weight will be usually higher or sulphonation degree, then hydrophylicity and/or salification proportions higher, leading to a better toxicological profile
Justification for selection of acute toxicity – oral endpoint
Study conducted on Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified and has been used as read across for Paraffin waxes and Hydrocarbon waxes, chloro, sulfochlorinated, saponified. This study is conducted in accordance with GLP compliance with international guideline
Justification for selection of acute toxicity – dermal endpoint
Study conducted on Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified and has been used as read across for Paraffin waxes and Hydrocarbon waxes, chloro, sulfochlorinated, saponified. This study is conducted in accordance with GLP compliance with international guideline
Justification for classification or non-classification
Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1 of CLP Regulation. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). The limit value that can trigger to Classification is 2000 mg/Kg both for oral and dermal exposure pattern
No classification for acute toxicity oral is warranted under Regulation 1272/2008
No classification for acute toxicity dermal is warranted under Regulation 1272/2008
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.
