Registration Dossier
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EC number: 263-174-9 | CAS number: 61791-42-2
- 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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 58.77 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No study on long term inhalation toxicity available.
- AF for dose response relationship:
- 1
- Justification:
- reliable dose-response, point of departure (POD) is NOAEL (no adverse systemic effects observed)
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-aute (28-day repeated dose) to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not necessary for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- no adverse systemic effects observed, ADME (see Chapter on "Toxicokinetics") suggests no significant interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- default for worker
- AF for the quality of the whole database:
- 1
- Justification:
- good quality data
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No study on long term dermal toxicity available.
- AF for dose response relationship:
- 1
- Justification:
- reliable dose-response, POD is NOAEL (no adverse systemic effects observed)
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute (28-day repeated dose) to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- the study was conducted with rats
- AF for other interspecies differences:
- 1
- Justification:
- no adverse systemic effects observed, ADME (see Chapter on "Toxicokinetics") suggests no significant interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- default for worker
- AF for the quality of the whole database:
- 1
- Justification:
- good quality data
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Important note:
Pursuant to ECHA decision CCH-D-2114394004-54-01/F (issued 22 March 2018) data on sub-acute and sub-chronic oral repeated dose toxicity according to OECD guideline 422 and OECD guideline 408, respectively, as well as data on prenatal developmental toxicity in rats according to OECD guideline 414 are currently being performed. Depending on the results of the prenatal developmental toxicity study in rats, a prenatal developmental toxicity study in a second species (oral route, rabbit) according to OECD guideline 414 will be considered. Since the results of the oral repeated dose toxicity studies and of the prenatal developmental toxicity study or any additional information relevant for the hazard assessment of Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts (CAS number: 61791-42-2) are not yet available, no changes regarding the endpoints repeated dose toxicity and toxicity to reproduction and developmental toxicity / teratogenicity are made. Based on the newly generated data, the hazard assessment with respect to toxicity after long-term exposure will be updated in due course.
Workers - Hazard via inhalation route
No route-specific acute and/or repeated inhalation toxicity studies are available for Sodium methyl cocoyl taurate and/or for the read-across substance Sodium methyl oleyl taurate. Route-to-route extrapolation is performed using the NOAEL of 1000 mg/kg bw/day from a 28-day oral toxicity study performed with the read-across substance Sodium methyl oleyl taurate, which was identified as key study for repeated dose toxicity. This NOAEL is used as starting point for the derivation of the worker DNEL "long-term inhalation exposure - systemic effects".
The corrected inhalatory NOAEC is obtained according to ECHA Guidance R.8 (ECHA, 2012) as 1763.16 mg/m³ (1000 mg/kg bw/day * (1/0.38 m³/kg bw/day) * (1/1) * 6.7 m³/ 10 m³). The assessment factors were chosen as described in ECHA Guidance R.8. Despite no systemic toxic relevant effects were noted and thus the point of departure (POD) used can be considered to be conservative, an assessment factor of 1 for dose-response is chosen. Since the assessment is based on the outcome of a 28 -day repeated dose toxicity study, time extrapolation to chronic exposure conditions generally have to be considered and the default factor of 6 (sub-acute to chronic) is used. With regard to interspecies differences, allometric scaling concerning oral-to-inhalation extrapolation is not appropriate and no assessment factor is applied. A factor of 1 for remaining interspecies differences is also supported, because toxicokinetic is considered to not differ between species. With regard to intraspecies variations, a default assessment factor of 5 was used to accommodate the variability in the human population. Since the available data on repeated dose toxicity are considered reliable and adequate, the quality of the data base is judged sufficient for evaluation and thus, an assessment factor of 1 is applied. Both, the target substance Sodium methyl cocoyl taurate and the read-across substance Sodium methyl oleyl taurate are chemically reaction products of fatty acid chlorides with sodium N-methyl taurinate and as such a close structural relationship exists. The only difference between both substances is seen in the origin of the fatty acid, which represents a C12-18-(even numbered, C18 unsaturated)-alkyl chain in the target molecule and a C18-(unsaturated)-alkyl chain in the source molecule.
The resulting overall assessment factor is 30 (6 x 5) resulting in a DNEL "long term inhalation exposure - systemic effects" of 58.77 mg/m³.
Workers - Hazard via dermal route
No route-specific repeated dermal toxicity data is available for Sodium methyl cocoyl taurate and/or the read-across substance Sodim methyl oleyl taurate. As default, route-to-route extrapolation is performed using the NOAEL of 1000 mg/kg bw/day from a 28-day oral toxicity study performed with the read-across substance Sodium methyl oleyl taurate, which was identified as key study for repeated dose toxicity. This NOAEL is used as starting point for the derivation of the worker DNEL "long term dermal exposure - systemic effects". The assessment factors were chosen based on the ECHA Guidance R.8 (ECHA, 2012). Despite no systemic toxic adverse effects were noted and thus the POD used can be considered to be conservative, assessment factors of 1 for dose-response and quality of data base seem to be appropriate. Since the assessment is based on the outcome of a 28-day repeated dose toxicity study, time extrapolation to chronic exposure conditions generally have to be considered and the default factor of 6 (sub-acute to chronic) is used. With regard to interspecies differences and to correct for differences in metabolic rate for the experimental animals, the default allometric scaling factor of 4 is chosen. A factor of 1 for remaining interspecies differences is also supported, because toxicokinetic is considered to not differ between species. With regard to intraspecies variations, a default assessment factor of 5 was used to accommodate the variability in the human population. The resulting overall assessment factor is 120 (6 x 4 x 5) leading to a DNEL "long-term dermal exposure - systemic effects" of 8.33 mg/kg body weight per day.
Additional information
No DNELs are derived for systemic toxicity and for local effects following acute exposure. It is concluded that short-term exposures are well-controlled by conditions for long-term exposure. Additionally, proper technical and personal risk management measures are in place to protect against local effects and ensure safe use conditions.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
With regard to consumer exposure, the registered substance is used only in cosmetic products. Therefore, derivation of DNELs, assessment of exposure and risk characterisation are not required under REACh. These uses are under the scope of Regulation (EC) No 1223/2009 on cosmetic products.
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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