Registration Dossier

Administrative data

Description of key information

The acute oral toxicity was tested with the read across substance Rape oil, sulfonated, sodium salt (CAS 91081-16-2) in young Wistar rats. No mortality was observed. According to this result the LD50 (oral) was determined to be >2000 mg/kg bw. Furthermore, the acute dermal toxicity was tested with Octadecanoic acid, sulfo-, potassium salt up to a concentration of 2000 mg/kg bw. No mortality was observed. According to this result the LD50 (dermal) was determined to be >2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Guideline and GLP study

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Guideline and GLP study

Additional information

A read across approach was applied for acute oral toxicity using data of the similar Rape oil, sulfonated, sodium salt. This substance is considered to show similar toxicological properties as compared to the test item. After passage of the stomach, the glyceride is degraded to glycerin and sulfonated fatty acids, mainly sulfonated oleic acid. In terms, of acute oral toxicity, there should be difference to sulfonated octadecanoic acid.

The acute oral toxicity of the read across substance Rape oil, sulfonated, sodium salt (CAS 91081 -16 -2) was tested in young Wistar rats (breeder Winkelmann, Borchen). The test compound was administered by single gavage in aqua dest water as solvent and in an application volume of 10 mL kg body weight. Five rats were used per sex. Neither mortality effects nor any other abnormalities were observed in this study. According to this result the LD50 was determined to be >2000 mg/kg bw for male rats and for female rats. The substance is not acute oral toxic for rats.

Furthermore, the acute dermal toxicity was tested with Octadecanoic acid, sulfo-, potassium salt up to a concentration of 2000 mg/kg bw. No mortality was observed. According to this result the LD50 (dermal) was determined to be >2000 mg/kg.


Justification for selection of acute toxicity – oral endpoint
Guideline and GLP study, only one study available

Justification for selection of acute toxicity – dermal endpoint
Guideline and GLP study

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is not considered to be classified for acute oral and dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.As a result the substance is not considered to be classified for acute oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 1297/2014.