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EC number: 269-915-2 | CAS number: 68390-97-6 This substance is identified by SDA Substance Name: C16-C18 alkyl dimethyl amine and SDA Reporting Number: 19-040-00.
- 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:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, C16-18-alkyldimethyl
- EC Number:
- 269-915-2
- EC Name:
- Amines, C16-18-alkyldimethyl
- Cas Number:
- 68390-97-6
- Molecular formula:
- R-N(Me)2, whereas R= C16-18-alkyl (even numbered, unbranched, saturated)
- IUPAC Name:
- N,N-dimethyl-C16-18-(even numbered)-alkyl-1-amines
- Details on test material:
- Based on the qualitative and quantitative information on the composition, the sample used is representative of the boundary composition shared and agreed by each registrant.
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: 12-16 weeks
- Weight at study initiation: 2.00- 3.00 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K., ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days with observation time points at 1 h, 24h, 48 h and 72 h and 7 days
- Number of animals:
- groups of 6 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: strip of surgical adhesive tape, elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM:
Erythema and eschar formation:
No erythema:0
Very slight erythema (barely perceptible):1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible):1
Slight oedema (edges of area well-defined by definite raising):2
Moderate oedema (raised approximately 1 millimetre ):3
Severe oedema (raised more than 1 millimetre extending beyong the area of exposure):4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 #3 and #6
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritation parameter:
- erythema score
- Basis:
- animal: #2,#4 and #5
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #5 and #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #5 and #6
- Time point:
- other: 48 and 72 h
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Remarks on result:
- other: No score could be determined due to other skin effects. Effects after 14 days: blanching of the skin, brown discoloration of the epidermis, scabbing, loss of skin flexibility, thickening of skin, glossy skin, dry straw-coloured crust, dried blood.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Remarks on result:
- other: effects after 14 days: Skin glossy, desquamation, loss of skin suppleness, thickening of dermal tissue, dry straw coloured crust, scar tissue
- Irritation parameter:
- edema score
- Basis:
- animal: #1,#2, #3 and #4
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritation parameter:
- edema score
- Basis:
- animal: #5 and #6
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #4 and #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: unclear due to other skin effects
- Irritant / corrosive response data:
- Severe dermal responses were produced after 4 h of exposure. The adverse skin reactions sometimes precluded accurate evaluation of erythema and oedema.
Very slight to well-defined erythema and slight to moderate oedema were noted one hour after patch removal. The reactions increased in severity and at subsequent observations were identified as well-defined erythema, slight to severe oedema, blanching of the skin, a brown discoloration of the epidermis, haemorrhage of the dermal capillaries, scabbing, loss of skin flexibility and elasticity, thickening of the skin, glossy skin, a dry straw-coloured crust (possible hyperkeratinisation), dried blood, desquamation. Scar tissue, indicative of dermal corrosion was noted in two rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The substance causes visible necrosis of the skin tissue at the site of contact when tested on the intact skin of an animal for a period of not more than four hours. Therefore the test item is classified as corrosive.
- Executive summary:
The irritancy/corrosivity was determined by semi-occlusive exposure of the intact skin of a group of six New Zealand white rabbits, for a period of four hours. The study was based on the OECD 404.
After 4 h exposure to the substance, washing with distilled water and an observation period of 14 days clear corrosiveness was determined. In 6/6 animals no erythema score and in 6/6 no edema score could be determined after 7 and 14 days due to other severe effects on the skin (i.e. scar tissue, thickening of the dermal tissue, desquamation.). Therefore the substance was classified as cossosive.
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