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Diss Factsheets
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EC number: 204-527-9 | CAS number: 122-19-0
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Modified Draize test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.6
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- other: Modification of the Draize technique (Draize, Woodward and Calvery 1944 NAS-NRC 1964).
- Justification for non-LLNA method:
- The Local Lymph Node Assay (LLNA; TG 429) was adopted in 2002.
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
- EC Number:
- 939-253-5
- Molecular formula:
- C12-16H25-33-(CH3)2-C6H5-N.CL
- IUPAC Name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- liquid
- Remarks:
- aqueous formulation
- Details on test material:
- Appearance: viscous solution (in 50% concentration)
For use: diluted in water
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - ca. 50% Cocobenzyldimethylammonium chloride (CAS no.: 61789-71-7) in water.
- Test subtance is based on full cocoalkyl chain.
- Chainlength distribution of full coco: C8: 5%; C10: 6%; C12: 50%; C14: 19%; C16: 10%; C18:10%.
In vivo test system
Test animals
- Species:
- guinea pig
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Induction 0.1% intracutaneous
Challenge 0.1% intracutaneous - Day(s)/duration:
- 1 day
Challenge
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Induction 0.1% intracutaneous
Challenge 0.1% intracutaneous - Day(s)/duration:
- 1 day
- No. of animals per dose:
- 6
- Details on study design:
- - 1st application: Induction 0.1 % intracutaneous
- 2nd application: Challenge 0.1 % intracutaneous
For the induction phase, 0.1 mL of a concentration of 0.1% of test substance in water was injected intradermally into the back of each six guinea pigs. This procedure was repeated every other days, using a different injection site on each occasion, until a total of nine injections had been given. Injection sites were examined 24h after each injection and scored for erythema and oedema using the Draize scale.
After completion of this series of priming injections the animals remained untreated for two weeks, and were then given a single challenge intradermal injection of the same concentration and volume as for induction. Injection sites were examined 24h after this challenge dose as before for erythema and oedema. The effects were compared to those produced by the priming doses in order to determine whether sensitisation had been produced. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: See 'Any other information on results incl. tables'
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Modified Draize test:
-
The priming injections elicited very slight to well defined
erythema, and very slight to slight oedma on all occasions.
- The challenge dose produced a well defined erythema and very
slight oedema in all occasions.
As the challenge doses did not produce any greater reaction
in any animal, it may be concluded that is not a sensitising
agent under the conditions of this experiment.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- not classified
- Conclusions:
- Under the study conditions, the test substance was considered to be non-sensitizing to guinea pig skin.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance, C12 -16 ADBAC (active: 50%), according to a method similar to EU Method B.6 (modified Draize test). For the induction phase, 0.1 mL of 0.1% test substance in water was injected intradermally into the back of each six guinea pigs. This procedure was repeated every other day, using a different injection site on each occasion, until a total of nine injections had been given. Injection sites were examined 24 h after each injection and scored for erythema and oedema using the Draize scale. After a two week interval, a single challenge intradermal injection of the same concentration and volume was given as for induction. Injection sites were examined 24 h after this challenge dose as before for erythema and oedema. The effects were compared to those produced by the priming doses in order to determine whether sensitisation had been produced. The priming injections elicited very slight to well defined erythema, and very slight to slight oedema on all occasions. The challenge dose produced a well-defined erythema and very slight oedema in all occasions. However, the challenge doses did not produce any greater reaction in any animal. Under the study conditions, the test substance was considered to be non-sensitizing to guinea pig skin (Thomas, 1974).
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.
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