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EC number: 269-924-1 | CAS number: 68391-05-9 This substance is identified by SDA Substance Name: C12-C18 dialkyl dimethyl ammonium chloride and SDA Reporting Number: 16-047-00.
- 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 September 15, 1987 to September 29, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Didecyldimethylammonium chloride
- EC Number:
- 230-525-2
- EC Name:
- Didecyldimethylammonium chloride
- Cas Number:
- 7173-51-5
- Molecular formula:
- C22H48N Cl
- IUPAC Name:
- N,N-Didecyl-N,N-dimethylammonium chloride
- Reference substance name:
- Propan-2-ol
- EC Number:
- 200-661-7
- EC Name:
- Propan-2-ol
- Cas Number:
- 67-63-0
- Molecular formula:
- C3H8O
- IUPAC Name:
- propan-2-ol
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
- Details on test material:
- - Didecyldimethylammonium chloride (DDAC)
- EC number: 230-525-2
To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant
Constituent 1
additive 1
additive 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12-16 wk
- Weight at study initiation: 2.19 - 2.42 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: closely clipping the fur from the dorsal/flank areas using veterinary clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Undiluted
- Duration of treatment / exposure:
- Upto 60 min
- Observation period:
- The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Clipped dorsal flanks
- Type of wrap if used: Occlusive patches
- 0.5 mL of test material was applied under occlusive patches on the clipped dorsal flanks of three rabbits and left for 3 min application on one flank and 60 min application on the other flank.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in 3 % (v/v) aqueous acetic acid followed by cotton wool soaked in distilled water.
EVALUATION:
Approximately 1 h following removal of the patches and 24, 48 and 72 h and 7 and 14 d later, the test sites (a total of six) were examined for evidence of primary irritation and scored according to Draize (1959).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (for 1 h exposure)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Eschar, moderate erythema extending beyond site, blanching of skin, scattered punctate formation
- Irritation parameter:
- edema score
- Remarks:
- (for 1 h exposure)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.56
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Oedema extending beyond site
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
Any other information on results incl. tables
After three minutes exposure:
No adverse skin reaction were noted at any treated skin site 1 h after the removal of the patches. Very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 and 48 h observations and at two treated sites at the 72 h observation.
After one hour exposure:
A light brown discoloration of the epidermis and slight
haemorrhage of the dermal capillaries were noted at all treated skin
sites 1 h after the removal of the
patches. Blanching of the skin was also noted at two of the
skin sites. Eschar had developed at all treated skin sites at the 24
h observation and continued to be noted at the 48, 72 h and Day 7
observation. Blanching and moderate erythema extending up to
approximately 7 cm beyond
the treatment site were also noted at all the treated skin
sites during this period. Scattered punctate eschar
surrounding two of the skin sites was also noted, with dry,
straw-coloured skin evident at all the sites on Day 7. On Day 14
sunken eschar was noted at all the treated skin sites.
Severe oedema was noted at all the treated sites 1h
after the removal of the patches. The oedema gradually
decreased and appeared as very slight to slight on Day 7.
The oedema extended approximately 2 to 3 cm beyond
all treated skin sites during this period. No oedema was noted on Day
14.
For result tables, kindly refer to the attached background material section of the IUCLID.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (corrosive) based on EU CLP criteria
- Conclusions:
- Under the study conditions, the test substance was found to be corrosive to skin in rabbits.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance, DDAC (80% active in hydroalcoholic solution), according to the OECD Guideline 404, in compliance with GLP. In the study, 0.5 mL test substance samples were applied under occlusive patches for both 3 and 60 min on the clipped skin of 3 rabbits. Residual test substance was removed using cotton wool soaked in 3% (v/v) aqueous acetic acid followed by distilled water. The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d. After 3 min exposure, very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 ad 48 h observations and at two treated sites at the 72 h observation. On Day 7 and 14, some hyperkeratinisation (2/3) and desquamation (1/3) was still present.After 1 h exposure, a light brown discolouration of the epidermis and slight haemorrhage of the dermal capillaries were noted at all treated skin sites 1 h after the removal of the patches. Blanching of the skin was also noted at two of the skin sites. Eschar had developed at all treated skin sites at the 24 h observation and continued to be noted at the 48, 72 h and Day 7 observations. Blanching and moderate erythema extending up to approximately 7 cm beyond the treatment site were also noted at all the treated skin sites during this period. Scattered punctuate eschar surrounding two of the skin sites was also noted, with dry, straw-coloured skin evident at all the sites on Day 7. On Day 14 sunken eschar was noted at all the treated skin sites. Severe oedema was noted at all the treated sites 1 h after the removal of the patches. The oedema gradually decreased and appeared as very slight to slight on Day 7. The oedema extended approximately 2 to 3 cm beyond all treated skin sites during this period. No oedema was noted on Day 14. Under the study conditions, the test substance was found to be corrosive to skin in rabbits (Guest, 1987).
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