Registration Dossier

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