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EC number: 224-388-8 | CAS number: 4337-75-1
- 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
With regard to the endpoint acute systemic toxicity, test data for the oral route on the read-across analogue source substance SMCT is available. Based on an OECD 401 acute oral toxicity study, the limit dose of 2000 mg/kg body weight revealed no mortality and no clinical signs of intoxication. Macroscopic findings during gross pathology were not observed. Based on the findings the LD 50 was established to be greater than 2000 mg/kg body weight. Hence, based on read-across, the acute oral toxicity of the registered/target substance SMLT is considered to be greater 2000 mg/kg body weight.
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
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across study
- Justification for type of information:
- This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. See section 13 for the full read-across justification.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, SPF breeding, Hoe:WISK(SPF71)
- Age at study initiation: 6 -7 weeks
- Weight at study initiation: 187 g +/- 7 g males, 180 g +/- 3 g females
- Fasting period before study: over night
- Housing: Macrolon cages (type 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 hours - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: recommended
MAXIMUM DOSE VOLUME APPLIED: 10 mL - Doses:
- 2000 mg/kg (limit dose)
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no lethality
- Clinical signs:
- yes (squatting posture, coat bristling)
- Body weight:
- not influenced
- Gross pathology:
- no findings
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Practically non-toxic via the oral route
- Conclusions:
- Based on the study results, sodium methyl cocoyl taurate (SMCT) is practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat.
This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat. Refer to section 13 for read-across justification. - Executive summary:
The acute oral toxicity of sodium methyl cocoyl taurate (SMCT) was tested in 5 male and 5 female Sprague Dawley rats at a dose level of 2000 mg/kg body weight (limit test) according to OECD Guideline 401. The animals received the compound once as a 20% suspension in water as vehicle via gavage and the administration volume was 10 mL/kg body weight. The observation period following treatment lasted 14 days. Unspecific symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 30 minutes up to 4 - 6 hours post application. No mortality occurred. From day 1 until the end of the observation period no symptoms of toxicity were observed. The development of body weight was not impaired. None of the animals showed macroscopically visible changes. Based on the study results, the median lethal dose (LD50) of SMCT is greater than 2000 mg/kg body weight in rats.
This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat. Refer to section 13 for read-across justification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The read-across source substance SMCT is parctically non toxic following acute oral administration up to the limit dose of 2000 mg/kg body weight. Data are reliable and meet criteria for classification & labeling requirements.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity of the read-across source substance SMCT was investigated in 5 male and 5 female rats using purified water as vehicle. The study was performed according to OECD test guideline 401 and followed the principles of GLP. 5male and 5 female animals were administered the test compound by single-dose gavage at a dose-level of 2000 mg/kg body weight. The observation period was 14 days. No deaths occurred during the study. Beside unspecific findings shortly after administration, clinical signs of intoxication were also not observed during the course of the study. Body weight development was normal and within the range commonly recorded for this strain and age. At necropsy no macroscopic findings were recorded. Based on the findings of this limit-test the median lethal dosage (LD50) of the source substance in female rats is greater than 2000 mg/kg body weight.
From the available data, based on read-across it is concluded that the registration/target substance SMLT is practically non-toxic following oral and/or dermal administration.
Justification for selection of acute toxicity – oral endpoint
Guideline read-across study according to GLP. No derivations and/or
confounders. Klimisch rating 1 representing reliability without
restrictions. Information is valid and meet data requirements.
Justification for selection of acute toxicity – inhalation endpoint
Waiving for scientific and exposure based reasons. Acute systemic
toxicity can be excluded for the oral and/or dermal route of exposure.
Additionally, due to the physico-chemical characteristics, no
significant potential concerning inhalation exposure exist.
Additionally, due to cosmetic use, vertebrate testing on SMLT is
prohibited according to Regulation (EC) 1223/2009.
Justification for classification or non-classification
With regard to the endpoint acute systemic toxicity, test data for the oral route on the read-across analogue source substance SMCT is available. Based on an OECD 423 acute oral toxicity study, the limit dose of 2000 mg/kg body weight revealed no mortality and no clinical signs of intoxication. Macroscopic findings during gross pathology were not observed. Based on the findings the LD 50 was established to be greater than 2000 mg/kg body weight. Hence, based on read-across, the acute oral toxicity of the registered/target substance SMLT is considered to be greater 2000 mg/kg body weight.
From the available read-across data, it is concluded that the registration/target substance SMLT is pactically non-toxic following oral and/or dermal administration and not classified for acute 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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