Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Sodium N-methyltaurinate is corrosive to the skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- OECD 404
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name of test material (as cited in study report): N-methylamino-ethansufonsaures Natrium (German)/sodium N-methylamino ethanesulfonate
Physical state: dehydrated
Composition:
- 76-84 % sodium N-methylamino ethanesulfonate
- 6-8 % sodium methylimino-di-ethanesulfonate
- 4-6 % sodium hydroxyethanesulfonate
- 1-2 % sodium hydroxide
- 1-3 % sodium sulfate
- 0-0.5 % sodium sulfite - Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 0.5-1 h, 24 h, 48 h, 72 h, 7 d, 14 d
- Number of animals:
- 3
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 - 60 min, 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 min to 7 days
- Score:
- >= 1 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of mild irritation
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Sodium N-methyltaurinate is shown to be corrosive to the skin of New Zealand White rabbits.
- Executive summary:
The guideline study on skin irritation / corrosion of sodium N-methyltaurinate was conducted according to OECD 404 using New Zealand White rabbits. The study reports that the application of 500 mg sodium N-methyltaurinate on shaved skin (semiocclusive coverage) with a residence time of 4 h results in edema and erythema. Therefore, it can be concluded that sodium N-methyltaurinate is corrosive to the skin and has to be classified as skin corrosive category 1C.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- 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 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals No. 435: In Vitro Membrane Barrier Test Method for Skin Corrosion, 19 July 2006
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: N-Methyltaurin 62
Batch No.: VSMT62lyy0020615
CAS No.: 4316-74-9
Chemical Name: Sodium N-methyltaurinate
Aggregate State at RT: liquid
Storage Conditions: room temperature
Active Components: 62 % solution of sodium N-Methyltaurinate
Stability: stable
Expiry Date: 06/2017
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety. - Test system:
- artificial membrane barrier model
- Remarks:
- In Vitro Membrane Barrier Test (CORROSITEX™ Assay)
- Justification for test system used:
- Justification for the Selection of the Test System: The CORROSITEX™ Assay is a standardized, quantitative in vitro test for skin corrosivity and has been validated by the ECVAM for testing acids, bases and their derivatives. The bio-barrier membrane is constructed to have physico-chemical properties similar to rat skin.
Justification for the Selection of the Test Method: This in vitro method is permitted by the UN GHS tiered testing and evaluation strategy for the assessment and classification of skin corrosivity. Substances classified as non-corrosive shall undergo additional testing in accordance with the tiered testing strategy. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test was carried out with the CORROSITEX™ Assay Kit (Invitro International; Irvine, CA 92614, Lot No.: CT 120314).
Prior to testing, the test substance was verified to be compatible with the COOROSITEX™ Assay.
The test was performed on a total of seven BIOBARRIERS (four BIOBARRIERS for the test item; one each for the positive and negative control and one as colour control). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The liquid test item was applied undiluted. 500 μL of the test item were placed directly atop the BIOBARRIER.
- Number of replicates:
- 4
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Replicate 1
- Value:
- 30.62
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Colour change: Yes; Consistency change: No.
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Replicate 2
- Value:
- 30.67
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Colour change: Yes; Consistency change: No.
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Replicate 3
- Value:
- 27.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Colour change: Yes; Consistency change: No.
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Replicate 4
- Value:
- 30.77
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Colour change: Yes; Consistency change: No.
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Positive control
- Value:
- 18.05
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: Colour change: Yes; Consistency change: No.
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Negative control
- Value:
- 74.88
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: Colour change: Yes; Consistency change: No.
- Other effects / acceptance of results:
- Replicates 1-4: The mean time required to activate the chemical detection system was 29.84 ± 1.69 min.
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- 62 % sodium N-methyltaurinate solution is shown to activate the chemical detection system between > 3 - 60 min (mean time: 29.84 ± 1.69 min) in an In Vitro Membrane Barrier Test (CORROSITEX™ Assay), resulting in the classification as skin corrosive 1B.
- Executive summary:
The guideline study on skin irritation / corrosion of 62 % sodium N-methyltaurinate solution was carried out according to OECD 435 using an In Vitro Membrane Barrier Test (CORROSITEX™ Assay). The study reports that the mean time to activate the chemical detection system is between > 3 - 60 min (29.84 ± 1.69 min) for the test substance. Therefore, 62 % sodium N-methyltaurinate solution should be classified as skin corrosive category 1B.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion:
According to the OECD 404 guideline study on New Zealand rabbits, sodium N-methyltaurinate is classified as skin corrosive category 1C. The same study on a 35 -37 % aqueous solution of sodium N-methyltaurinate is reported to be neither irritating nor corrosive to skin. The two in vitro guideline studies according to OECD 435 for 40 % and 62 % aqueous solutions of sodium N-methyltaurinate were carried out using an In Vitro Membrane Barrier Test (CORROSITEX™ Assay). According to the studies, both solutions are classified as skin corrosive category 1B.
Eye irritation/damage:
According to Regulation (EU) No. 1907/2006, Annex VII, the studies for this endpoint do not need to be conducted, because the substance is classified as skin corrosion (category 1). Sodium N-methyltaurinate is classified as skin corrosive category 1C (see above), leading to classification as serious eye damage (category 1) according to Regulation (EU) No. 1272/2008. According to two OECD 405 guideline studies on New Zealand White rabbits, both sodium N-methyltaurinate and a 35-37 % aqueous solution of sodium N-methyltaurinate are classified with eye damage category 1.
Justification for classification or non-classification
The OECD guideline studies on the irritation/corrosion properties of sodium N-methyltaurinate show that the substance is skin corrosive and needs to be classified for skin corrosion and eye damage.
Skin corrosion / irritation:
The in vitro studies on 40 % and 62 % aqueous solutions of sodium N-methyltaurinate according to OECD 435, In Vitro Membrane Barrier Test (CORROSITEX™ Assay), showed that both solutions have to be classified as skin corrosive category 1B. In addition, the OECD 404 guideline study on New Zealand rabbits on sodium N-methyltaurinate showed that the substance needs to be classified as skin corrosive category 1C.
In conclusion, the results of the in vivo study will be applied and sodium N-methyltaurinate has to be classified as skin corrosive category 1C.
Eye irritation endpoint:
According to Regulation (EU) No. 1907/2006, Annex VII, the studies for this endpoint do not need to be conducted, because the substance is classified as skin corrosion (category 1). Thus, the classification of sodium N-methyltaurinate as skin corrosive category 1C (see above) leads to classification as serious eye damage (category 1) according to Regulation (EU) No. 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.