Sodium 2-sulphonatoethyl laurate

Carcinogenicity

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Endpoint:

carcinogenicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

carcinogenicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via dermal route

Link to relevant study records

Reference

Endpoint:

carcinogenicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Testing of lauric acid 2-sulfoethyl ester, sodium salt (sodium lauroyl isethionate) CAS No 7381-01-3 for carcinogenicity is not justified, based upon a weight of evidence from read-across substances:Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789-32-0 and sodium 2-hydroxyethanesulfonate CAS No 1562-00-1.

Classification for genotoxicity is based upon read-across from the source chemical Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789-32-0 to the target substance. There is one Ames bacterial reverse mutation study, a Mouse lymphoma L5178Y (TK+/-) mammalian cell mutation assay and two assays for clastogenicity, the in-vitro micronucleus assay and the Chromosomal Aberration assay in Chinese hamster ovary. All studies are of high quality all being Klimisch 2. The studies are all consistently negative, so there is a significant weight of evidence that Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789-32-0 is not mutagenic or clastogenic. There are no data to indicate any requirement to classify Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789-32-0 and consequentlylauric acid 2-sulfoethyl ester, sodium salt (sodium lauroyl isethionate) CAS No 7381-01-3for genetic toxicity.

Sodium 2-hydroxyethanesulfonate CAS No 1562-00-1,predicted to be the major toxicophore following phase I metabolism (Meteor Nexux 1.5.1, LHASA), was tested in a 90 day oral toxicity study conducted in rats. Males and females treated with 1000 mg/kg/day showed elevated incidences of liver foci when compared with the respective controls during necropsy. This finding was considered to be test item related.

Histopathlogical examination confirmed that the livers of animals treated with 1000 mg/kg/day showed degeneration, necrosis (focal or of single hepatocytes), bile duct hyperplasia, focal hepatocytic hyperplasia (very likely regenerative), peribiliary fibrosis and an increased incidence and severity of mixed inflammatory cells infiltration in the parenchyma. Increased hemopoiesis was seen in the spleen of animals at 1000 mg/kg/day. After 28 days of recovery, there was the total reversibility of the findings: the livers and spleens of animals treated previously with 1000 mg/kg/day reverted to normal, indicating that the hyperplasia observed was a transient effect related tofocal hepatic necrosis. There was no evidence of pre-neoplastic lesions in the tissues examined.

In combination, the lack of genotoxicity observed in the source substance Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789-32-0 and the transient nature of hepatic hyperplasia induced by the metabolite Sodium 2-hydroxyethanesulfonate CAS No 1562-00-1 indicate that further testing of the target substancelauric acid 2-sulfoethyl ester, sodium salt (sodium lauroyl isethionate) CAS No 7381-01-3 for carcinogenicity is not scientifically justified.

Consequently, based upon the available testing results, classificationof the target substance lauric acid 2-sulfoethyl ester, sodium salt (sodium lauroyl isethionate) CAS No 7381-01-3 is not justified.

Additional information

Justification for selection of carcinogenicity via oral route endpoint:

Testing for carcinogenicity has been waived based upon the following findings:

Sodium lauroyl isethionate is not classified as a germ cell mutagen; results from the testing of the surrogate substance sodium cocoyl isethionate demonstrate that the substance is negative in the: Ames test; in vitro mammalian cell gene mutation assay; in vitro micronucleus assay and the in vitro chromosome aberration assay;

Histopathlogical lesions observed in the livers of animals treated for 90 days with 1000 mg/kg/day sodium 2-hydroxyethanesulfonate CAS No 1562-00-1 (including focal/ hepatocyte necrosis, bile duct hyperplasia, focal hepatocytic hyperplasia, peribiliary fibrosis and parenchymal mixed inflammatory cells infiltrate) fully reversed following a 28 day recovery period; the livers and spleens of animals treated previously with 1000 mg/kg/day reverted to normal, indicating that the hyperplasia observed was a transient effect related tofocal hepatic necrosis. There was no evidence of pre-neoplastic lesions in the tissues examined.