Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Castor Oil, Sulfated, Sodium Salt, 75% was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone) and did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the four tester strains (TA1535, TA1537, TA98 and TA100) or in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation.

Furthermore Castor Oil, Sulfated, Sodium Salt, 75% was tested for chromosomal aberration on humal lymphocytes and no effects on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix.

Castor Oil, Sulfated, Sodium Salt, 75% does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report.

Gene mutation has been also tested on the analogous substance with negative results and based on the assessment reported in the endpoint for mammalian gene mutation on Castor oil, it can be concluded that Castor Oil has no effects on genetic toxicity.


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

The substance is not classified for genetic toxicity following CLP criteria set out in the EC 1272/2008 Regulation