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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-036-1 | CAS number: -
- 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
Acute oral toxicity: Cetyldimethylbetaine LD50 (rat) is >300 <2000 mg/kg bw.
Acute inhalation toxicity: No study available.
Acute dermal toxicity: The substance is not expected to penetrate the skin in sufficient quantities to result in acute toxic effects.
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:
- 19 October - 12 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Batch No.: UB 4051
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Rive Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg &, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Not specifically mentioned.
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 169-184 g
- Fasting period before study: 16 hours
- Housing: during the 14 day observation period the animals were kept in groups of 3 in MAKROLON cages (type III plus).
- Diet: commercial diet, ssniff R/M-H V1534 ad libitum. Discontinued 16 h before administration.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 12-18
- Photoperiod (hrs dark / hrs light): 12/12 (approx 150 lux when lit)
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not stated
- Amount of vehicle (if gavage): not stated
- Justification for choice of vehicle: Test item soluble in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw per administration
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg bw based on expected low toxicity of the test item. - Doses:
- 300 or 2000 mg/kg bw, given as two doages of 150 or 1000 mg/kg bw, respectively.
First administration at t = 0 h
Second administration at T = 3 h. - No. of animals per sex per dose:
- 6 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration, then daily during the 14-d period. Body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological changes. - Statistics:
- Not applicable
- Preliminary study:
- Not applicable
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bw - no deaths
2000 mg/kg bw - 4/6 animals died - Body weight:
- All surviving animals gained the expected wieght at the end of the study period.
- Gross pathology:
- No pathological changes observed at necropsy
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of this study, the LD50 is >300 <2000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The Source substance is the monconstituent C16 alkyldimethyl betaine. The Target is C12-16 (even numbered) -alkyldimethylbetaine, where 65-70% of the betaine content is the C16 chainlength and the remainder C12-14. Both substances will have similar properties and read across from the C16 to the C12-16 is possible.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: (carboxylatomethyl)hexadecyldimethylammonium [EC 211-748-4, CAS 693-33-4]
Target: betaines, C12-16 (even numbered) -alkyldimethyl [EC 947-036-1, CAS n/a]. Composition information per section 1.2
3. ANALOGUE APPROACH JUSTIFICATION
The Source substance, C16 betaine, makes up 65-70% of the betaine content in the Target substance, with C12 and C 14 betaines making up the remainder. Therefore the C16 betaine will make a proportionally greater contribution to acute toxicity compared to the C12-14 betaine. It should be noted that C12-14 betaine has not been classified for acute toxicity via the oral route according to information available on ECHA's dissemination website.
4. DATA MATRIX
Source: (carboxylatomethyl)hexadecyldimethylammonium [EC 211-748-4, CAS 693-33-4]: LD50 is >300 - <2000 mg/kg bw
Target: betaines, C12-16 (even numbered) -alkyldimethyl [EC 947-036-1, CAS n/a]: no data available. - Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- Not applicable
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Acute oral toxicity: Cetyldimethylbetaine LD50 (rat) is >300 <2000 mg/kg bw. Acute category 4 under CLP.
No data available for inhalation or dermal routes.
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.