Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
49.5 mg/m³
Study duration:
subacute
Species:
rat

Additional information

Multiple repeat dose studies on representative alkaryl sulfonate salts are available to assess the hazard following repeated exposure of EC No. 271 -877 -7.

Oral repeated dose: The ACC study on CAS # 115733 -09 -0 is selected as the key study to meet the endpoint requirement for the registration because it is most chemically similar to the substance being registered. In a fully compliant OECD 407 Guideline study, a NOAEL of 1000 mg/kg bw/day was established in male and female rat.

Dermal repeated dose: No study is available for this endpoint. However, according to the Commission Guidance on Dermal Absorption, 2004, absorption is expected to be limited for substances with molecular weight > 500 and Log Kow values outside the range of 1 - 2. Based on this guidance, alkaryl sulfonate salts would generally be expected to be very poorly absorbed in contact with skin. Because of this and because data are available for the oral and inhalation routes of exposure following repeat dosing, it is considered unnecessary to generate data by this route of exposure. This endpoint is waived.

Inhalation repeated dose: A single valid study on a representative alkaryl sulfonate salt is available to evalute the toxicity of the substance following repeated inhalation exposure. The data are considered adequate for this purpose. A NOAEL of 49.5 mg/m3 was established in this study.

Justification for classification or non-classification

Representative alkylbenzene sulfonate salts do not meet the criteria set out in Directive 67/548/EEC and also Regulation (EC) 1272/2008 for target organ effects following repeated exposure. Classification of EC No. 271 -877 -7 for effects following repeated exposure is not considered to be necessary based on chemical similarity to those representative substances.