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EC number: 224-339-0 | CAS number: 4316-74-9
- 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
Endpoint summary
Administrative data
Description of key information
The guideline study on acute oral toxicity of sodium N-methyltaurinate was conducted according to OECD 401 using Sprague-Dawley rats. LD0 and NOAEL of sodium N-methyltaurinate are >= 2500 mg/kg bw. The test animals did not show any signs of intolerance reactions and no pathological signs have been found from the autopsies. This result is supported by another provided OECD 401 guideline study, which reports the acute oral toxicity of sodium N-methyltaurinate on Wistar rats. The tested LD50 in this study is >= 4670 mg/kg bw. These findings reflect the low toxicity of sodium N-methyltaurinate. In conclusion, the substance does not need to be classified for oral toxicity according to GHS criteria.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- This study was carried out according to the OECD Guidelines for the testing of Chemical No. 401 and the EEC Guidelines: Official Journal of European Communities L 251: Acute toxicity (oral) and Annex V, B.1.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Na-Methyltaurid
Supplier: Leuna-Werke AG
Batch No.: MM 90100512E
Assay: Sodium methyltauride 46.4 %; monomethylamine 0.013 %; solid material (total) 49.1 %
Substance type: aqueous solution
Physical state: liquid
Stability: During the course of the study
Storage conditions: Room temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Number of animals: 20 (10 males, 10 females)
Identification of animals: By coloured marks
Duration of adaption: At least 5 days
Initial weight of animals:157-187 g; age: appr. 40-60 days. Animals were randomized before use. - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropyl-methyl-cellulose gel
- Doses:
- Single oral administration
2 dose-levels of 5 males and 5 females, 2000 mg/kg and 2500 mg/kg bw.
Dose-levels refer to Sodium methyltauride (total solid material)
Volume of application: 20 mL/kg bw. for each group
Dose interval factor: 1.25 - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Standardized diet for rats and mice ALTROMIN 1324 (ALTROMIN GmbH, Lage/Lippe, Germany) served as food. Feeding was discontinued ca. 16 hours before administration. Only tap water was then offered ad lib. Observations were performed immediately, 5 min, 15 min, 30 min, 60 min, 3 h, 6 h, 24 h after administration. All animals were observed for a period of 14 days.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Remarks:
- (24 h)
- Effect level:
- >= 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No signs of intolerance reactions. Autopsy: no pathological findings
- Sex:
- male/female
- Dose descriptor:
- LD0
- Remarks:
- (14 days)
- Effect level:
- >= 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No signs of intolerance reactions. Autopsy: no pathological findings
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Effect level:
- >= 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No signs of intolerance reactions. Autopsy: no pathological findings
- Mortality:
- No mortality was reported for the total test duration (14 days).
- Clinical signs:
- other: No signs of intolerance reactions. Autopsy of surviving animals (sacrificed) (male and female): No pathological findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD0 and NOAELof sodium N-methyltaurinate are >= 2500 mg/kg bw. Test animals did not show any signs of intolerance reactions and no pathological signs have been found from the autopsies.
- Executive summary:
The guideline study on acute toxicity (oral) of sodium N-methyltaurinate was carried out according to OECD 401 using Sprague-Dawley rats. LD0 and NOAELof sodium N-methyltaurinate are >= 2500 mg/kg bw. Test animals did not show any signs of intolerance reactions and no pathological signs have been found from the autopsies. In conclusion, the substance does not need to be classified for oral toxicity according to GHS criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- The study has been done according to OECD 401.
Additional information
Justification for classification or non-classification
For sodium N-methyltaurinate the LD0 and NOAEL are >= 2500 mg/kg bw. For classification according to EU Regulation No. 1272/2008 an LD50 of equal or less than 2000 mg/kg bw is required. Therefore, sodium N-methyltaurinate does not need to be classified for oral toxicity.
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