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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-471-7 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23th to 30th December 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate
- EC Number:
- 947-471-7
- Molecular formula:
- C22H47N2O.CH3O4S - C3H8O2 - C24H51N2O.CH3O4S
- IUPAC Name:
- Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate
- Test material form:
- cream / paste
- Remarks:
- cream coloured paste
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.59 - 2.95 kg
- Housing: individual housing in a suspended metal cage
- Diet: free access throughout the study (RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: free access throughout the study
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 20 °C
- Humidity: 42 - 56 %
- Air changes: approximately 15 changes per hour
- Photoperiod: 12 hours light and 12 hours darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Treatment of test material prior to testing: for the purpose of this study the test material was warmed in a water bath prior to use.
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test material was introduced under a 2.5 cm × 2.5 cm gauze patch and placed in position on the shorn skin. - Duration of treatment / exposure:
- 4 h
- Observation period:
- up to 7 days after treatment
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: a skin area under a 2.5 cm × 2.5 cm gauze patch
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm × 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 h after application
OBSERVATION TIME POINTS
- 1 hour following the removal of the patch, and 24, 48 and 72 hours later
SCORING SYSTEM:
- The test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
- Method of calculation: the scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by 6 to give the primary irritation index of the test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites one hour after patch removal. Very slight to well-defined erythema was noted at all treated skin sites at the 24-hour observation with well-defined erythema at the 48-hour observation and very slight to well-defined erythema at the 72-hour observation.
Very slight to slight oedema was noted at all treated skin sites at the 24 and 48-hour observations with very slight oedema at the 72-hour observation. - Other effects:
- Crust formation or desquamation were noted at all treated skin sites 7 days after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (skin irritation) based on criteria in the CLP Regulation (EC 1272/2008).
- Conclusions:
- Irritant to skin based on crust formation or desquamation noted at all treated skin sites 7 days after treatment.
- Executive summary:
The study was performed to assess the irritancy potential of the test item following a single, 4-hour, semi-occluded application to the intact rabbit skin following the OECD guideline 404 (1981).
Very slight erythema was noted at two treated skin sites one hour after patch removal. Very slight to well-defined erythema was noted at all treated skin sites at the 24-hour observation with well-defined erythema at the 48-hour observation and very slight to well-defined erythema at the 72-hour observation.
Very slight to slight oedema was noted at all treated skin sites at the 24 and 48-hour observations with very slight oedema at the 72-hour observation.
Signs of erythema and oedema were all reversible within 7 days.
Crust formation or desquamation were noted at all treated skin sites 7 days after treatment.
Based on effects noted 7 days after treatment, the test item is classified as skin irritant according to the CLP Regulation (EC 1272/2008).
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.