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EC number: 211-669-5 | CAS number: 683-10-3
- 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
From the surrogate data available, this substance does not appear to exhibit acute toxicity.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Only very limited documentation, only 5 days observation period
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Physical state: liquid, aqueous solution
- Analytical purity: 30% a.i.
- Composition of test material, percentage of components: 30 % active (C8-18 with majority in C12-14), 7 % sodium chloride, 63 % water
- Lot/batch No.: 26R-259.
The members of the alkyl betaines category are amphoteric surfactants containing a quaternary ammonium ion and a carboxylic structure. They are referred to as inner salts due to their zwitterionic character. They are all manufactured from natural materials such as vegetable oils and can vary in chain length from C8 to C18. They are generally marketed as aqueous solutions (20 - 40 %).
Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected.
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. - Species:
- mouse
- Strain:
- CF-1
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- - Source: Charles River
- Weight at study initiation: 18 - 21 g
- Fasting period before study: no data
- Housing: 5/cage
- Diet (e.g. ad libitum): Lab Blox, ad libitum
- Water (e.g. ad libitum): ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- - Concentration in vehicle: 10 % (test material was diluted 1:3 in water just prior to the test)
- Doses:
- 6670, 8350, 10000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days
- Necropsy of survivors performed: no data - Statistics:
- Oral LD50 was calculated according to the method of Litchfield and Wilcoxon (1949).
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 640 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 2 310 - <= 3 000
- Remarks on result:
- other: recalculated to neat substance
- Mortality:
- 10000 mg/kg: 7/10
8350 mg/kg: 4/10
6670 mg/kg: 1/10 - Clinical signs:
- other: not reported
- Gross pathology:
- not reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cocoalkyldimethylbetaine has a similar structure to lauryl betaine.This is considered to be a good surrogate substance for the lauryl betaine being registered.
Further animal testing cannot be justified. - Executive summary:
The members of the alkyl betaines category are amphoteric surfactants containing a quaternary ammonium ion and a carboxylic structure.
Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected. 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.
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study waived due to provisions of other regulation
- Justification for data waiving:
- other:
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Single dose, 14 day observation
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- EPA review of data
Study performed on non-phosphated form
Results used to help confirm biological equivalence for read across - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- other: Old LD50 protocol
- Limit test:
- no
- Specific details on test material used for the study:
- The members of the alkyl betaines category are amphoteric surfactants containing a quaternary ammonium ion and a carboxylic structure. They are referred to as inner salts due to their zwitterionic character. They are all manufactured from natural materials such as vegetable oils and can vary in chain length from C8 to C18. They are generally marketed as aqueous solutions (20 - 40 %).
Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected.
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.
This is considered to be a good surrogate substance for the substance being registered.
Further animal testing cannot be justifed. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- Dose levels based on actives; 1200 mg/kg - 10 000 mg/kg
- No. of animals per sex per dose:
- Five
- Control animals:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 500 mg/kg bw
- Based on:
- act. ingr.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The members of the alkyl betaines category are amphoteric surfactants containing a quaternary ammonium ion and a carboxylic structure. They are referred to as inner salts due to their zwitterionic character. They are all manufactured from natural materials such as vegetable oils and can vary in chain length from C8 to C18. They are generally marketed as aqueous solutions (20 - 40 %).
Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected.
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.
Cocamidopropyl betaine is considered to be a good surrogate substance for the substance being registered.
Further animal testing cannot be justifed.
(Note - HPV reports indicate other acute toxicity tests and although some variation in results, it is concluded that the substance need not be classified as harmful)
Referenceopen allclose all
Mortality reported at highest concentrations
No pathology reported
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 hours on occluded skin
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- No details given in the review report.
- Test type:
- standard acute method
- Specific details on test material used for the study:
- 94.9% pure
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Groups of 5 male Sprague-Dawley rats received the test material dermally on clipped trunks; test sites were occluded for 24 h, after which the test sites were wiped clean of the test material
- Duration of exposure:
- 24 hours
- Doses:
- not specified
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 16 other: g/kg
- Based on:
- test mat.
- Clinical signs:
- other: Erythema, edema, desquamation, necrosis, and scab formation observed on test sites for test material, as was sluggishness and reddish nasal and ocular discharges; body weight gains within normal parameters; no treatment-related changes due to either test
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cetyl betaine is not harmful by skin absorption.
Lauryl betaine has a very similar structure to cetyl betaine, the only difference being in the chain length of the alkyl grouping, i.e. C16 9cetyl) vs C12 (lauryl).
The CIR 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' - Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 24 hours exposure; 14 day observation
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- US EPA source considered reliable
Test performed on analogue substance; Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected between this test material and cetyl betaine.
Although headline result is LD50 > 2 g/kg, it is uncertain if this relates to the active or to a diluted test material.
However, the EPA have judged the result as 'valid without restrictions' and cited 2 g/kg. - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Limit test
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Source not specified. Activitiy not specified (not known if test material was a diluted form)
- Species:
- rat
- Strain:
- CD-1
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg (assumed actives)
- No. of animals per sex per dose:
- Five
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: Local irritation
- Gross pathology:
- No adverse effects on termination
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Local irritation, but this resolved during the observation periods
Although headline result is LD50 > 2 g/kg, it is uncertain if this relates to the active or to a diluted test material.
However, the EPA have judged the result as 'valid without restrictions' and cited 2 g/kg. - Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- 30 – 35.5 % aqueous solution.
Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected between this test material and cetyl betaine. - Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The acute toxicity of cocamidopropyl betaine (30 – 35.5 % aqueous solutions) in rats is low, with a dermal LD50 value greater than 2000 mg/kg bw.
The active ingredient level is ca. 600 mg/kg/bw but since the test does not appear to have been taken to a higher level of active ingredient, this value cannot be used for classification. - Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The members of the alkyl betaines category are amphoteric surfactants containing a quaternary ammonium ion and a carboxylic structure.
Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected. 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.
Justification for classification or non-classification
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.