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Diss Factsheets
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EC number: 940-223-9 | CAS number: -
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Validity of the study assessmed by the CIR Expert Panel
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final report on the safety assessment of alkyl sarcosines and sodium alkyl sarcosinates
- Author:
- Cosmetic Ingredient Review Panel
- Year:
- 2 001
- Bibliographic source:
- Int. J. Toxicol. 20: 1-14, 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 2-year feeding toxicity study
- Version / remarks:
- The study integrates the mating of males and females
- Principles of method if other than guideline:
- 2-year feeding toxicity study
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium lauroyl sarcosinate
- IUPAC Name:
- Sodium lauroyl sarcosinate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily (feeding)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 000 mg/kg diet
- Remarks:
- 0.05% of the test item in the diet for the first 6 months and 2.0% of the test item in the diet for the remaining 18 months
- Dose / conc.:
- 10 000 mg/kg diet
- Remarks:
- 1.0% of the test item in the diet for 24 months
- Dose / conc.:
- 2 000 mg/kg diet
- Remarks:
- 0.2% of the test item in the diet for 24 months
- Dose / conc.:
- 0 mg/kg diet
- Remarks:
- Basal diet alone
- No. of animals per sex per dose:
- 25 per sex per group
- Control animals:
- yes, plain diet
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- hyperplasia of squamous epithelium with keratin formation of the mucosa of the stomach at two highest dose groups
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect up to the highest dose
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Citation:
"...Two hundred albino Sherman Wistar rats (25 rats/sex/group; 100-150 g) were fed Sodium Lauroyl Sarcosinate during a 2-year chronic oral toxicity study. Group 1 was fed 0.05% Sodium Lauroyl Sarcosinate in the daily diet for the first 6 months of the study and 2.0% of dies for the remaining 18 months. For the entire study period, group 2 was fed 0.2% of diet, group 3 was fed 1.0% of diet, and group 4 was fed the basal diet alone. Rats were killed at 1,3,6, and 24 months for necropsy and tissues collected for microscopic examination; organs examined included the liver, spleen, heart, lungs, stomach, large intestine, small intestine, adrenal glands, gonads, pancreases, and brain. Blood samples were drawn and analyzed at 30 days, 90 days, 6 months, and 24 months for red and white blood cell counts, hemoglobin content, and differential count. Males and females were housed together so that ferility could be assessed. At 1,3,6 months, no significant differences were observed in lesions, fertility, mortality, hematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test article was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test article-group1 (2% in the diet after 6months) and group 3 (1% in the diet)...."
Applicant's summary and conclusion
- Conclusions:
- Sodium N-Lauroyl sarcosinate was investigated in rats for its chronic toxicity and reproduction toxicity in a 2 -year feeding study. The doses levels applied were 0, 0.2, 1 and 2% in the diet. Males and females were housed together so that fertility could be assessed. No effect on the fertility was found. Histopathological changes of stomach tissues were evident at dose levels of 1 and 2% in the diet. No significant systemic effect was found up to the highest dose level.
- Executive summary:
The subacute toxicity of the registration substance Hostapon SLG was evaluated based on the read-across approach using the repeated dose toxicity data for sodium N-lauroyl sarcosinate
The registration substance and the read-across sources are amides of fatty acids and amino acids and can be characterized as "N-fatty acyl amino acids", of which endogeous occurence and metabolism are known. Based on the comparable chemical structure, comparable phys-chem data and expected comparable metabolism, these compounds are likely exhibit comparable toxicity profiles.
Sodium N-lauroyl sarcosinate was investigated in rats for its chronic toxicity and reproduction toxicity in a 2 -year feeding study. The doses levels applied were 0, 0.2, 1 and 2% in the diet. Males and females were housed together so that fertility could be assessed. No effect on the fertility was found. Histopathological changes of stomach tissues were evident at dose levels of 1 and 2% in the diet. No significant systemic effect was found up to the highest dose level.
Likewise, the registration substance Hostapon SLG is likely of low repeated dose toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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