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EC number: 230-949-8 | CAS number: 7381-01-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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.
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