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Diss Factsheets
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EC number: 211-748-4 | CAS number: 693-33-4
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 96 hour
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Taken from Australian NICNAS report reviewing class of substance confirms that fish is typically no more sensitive than algea or Daphnia and further animal testing is not justified.
The sulphated betaine substance in this summary was selected for read-across as it contains the same betaine group considered responsible for the main toxicological effects on aquatic organisms. The additional sulphate group will reduce surface tension further than the carboxylate group that is present in the substance to be registered. - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- not specified
- Remarks:
- No details given in the publication
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- other: Review covering three species
- Details on test organisms:
- Different species; Zebra Fish, Red Killifish, Rainbow Trout
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Not specified
- Hardness:
- Within guidelines
- Test temperature:
- Within guidelines
- pH:
- Within guidelines
- Dissolved oxygen:
- Within guidelines
- Nominal and measured concentrations:
- Not specified
- Reference substance (positive control):
- not specified
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 2.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Rainbow trout
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 9.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Red killifish
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 36.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Zebra fish
- Details on results:
- Zebra fish, LC50 ≥ 36.8 mg/L; Red killifish, LC50 ≥ 9.2 mg/L;Rainbow trout, LC50 ≥ 2.6 mg/L.For the purposes of classification, the minimum median lethal concentration of the most sensitive fish species (rainbow trout 96 h EC50 = 2.6 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The review document did not provide great detail of the testing, but the data were considered valid by the assessors working under Australian NICNAS. The headline result for rainbow trout was approximatley as sensitive as to Daphnia and algea in this review and for the other two species, fish appear more tolerant than the other types of organism. The sulphated betaine substance in this summary was selected for read-across as it contains the same betaine group considered responsible for the main toxicological effects on aquatic organisms.
In conclusion, it is not considered warranted to perform additional testing on vertebrates. - Executive summary:
The read-across to the sulphated betain is considered justified as the phosphate ester is considered likely to partly hydrolyse to form products that include phosphated betaines. The sulphate will have similar surface active properties and indeed, appears ot have similar effects to Daphnia.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 96 hours
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- US EPA Published
Primary source not known - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Principles of method if other than guideline:
- Methods not fully described
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Source not specified
- Analytical monitoring:
- not specified
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 2 mg/L
- Conc. based on:
- act. ingr.
- Remarks:
- reported for substance
- Basis for effect:
- mortality (fish)
- Validity criteria fulfilled:
- not specified
- Conclusions:
- Fish appear to be less sensitive than algae to this class of substance.
Further testing is not justified.
Referenceopen allclose all
Description of key information
The read-across to these other betaine species is considered justified. The Cosmetic Ingredient Review Expert Panel reviewed the product use, formulation and safety data of eleven alkyl betaines, as used in cosmetics. (Final report issued 2014-04-04). The Panel concluded that the common core chemical structure, similar functions and concentrations in cosmetics, and the predicted physicochemical properties enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each individual compound in the entire group
Evidence shows that fish are more tolerant to the class of substance than algae and further animal testing is not justified
Acute toxicity is predicted to be in the range of 1 - 10 mg/l. The value chosen here is the lowest value from the published data on various fish species.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 2 mg/L
Additional information
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.