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EC number: 269-923-6 | CAS number: 68391-04-8 This substance is identified by SDA Substance Name: C12-C18 alkyl dimethyl amine and SDA Reporting Number: 16-040-00.
- 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:
- From 24 SEP 1987 to 10 NOV 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline 404.
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, C12-18-alkyldimethyl
- EC Number:
- 269-923-6
- EC Name:
- Amines, C12-18-alkyldimethyl
- Cas Number:
- 68391-04-8
- Molecular formula:
- R-N(Me)2, whereas R= C12-18-alkyl (even numbered, unbranched, saturated)
- IUPAC Name:
- N,N-dimethyl-C12-18-(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: 2.35-2.84 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14-21
- Humidity (%): 45-70
- 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:
- 0.5 mL of the test material
- Duration of treatment / exposure:
- 3 min, 1 h, 4 h
- Observation period:
- 1, 24, 48 and 72 hours, 7 and 14 days
- Number of animals:
- 6 animals (3 animals for the 4 h exposure time, and 3 animals for 3 minutes and 1 h exposure combined)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, gauze patches
REMOVAL OF TEST SUBSTANCE
- test material was removed by gentle swabbing with cotton wool soaked in 3% (v/v) aqueous acetic acid followed by cotton wool soaked distilled water.
- Time after start of exposure: 3 min and 1 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:
- mean
- Remarks:
- test item exposure: 4 h
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: reversibiliy cannot be determined due to other skin effects
- Remarks on result:
- other: effects after 14 days: glossy skin, desquamation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- test item exposure: 4h
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2 and #3, test item exposure: 4 h
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- For a detailes list of individual scores see table in section "Any other information on results incl. tables".
Any other information on results incl. tables
three minutes exposure
Skin reaction | Reading (hours) | Individual scores - rabbit number 1 -3 | ||
Erythema / eschar formation | 1 | 1 | 1 | 1 |
24 | 2 | 2 | 2 | |
48 | 2 | 2 | 2 | |
72 | 2 D | 3 D | 2 D | |
7 Days | HyCrTL | HyCrTL | HyCr | |
14 Days | 0 | 0 | 0 | |
Oedema formation |
1 | 1 | 1 | 1 |
24 | 2 | 2 | 2 | |
48 | 2 | 2 | 1 | |
72 | 2 | 2 | 1 | |
7 Days | 0 | 0 | 0 | |
14 Days | 0 | 0 | 0 | |
One hour exposure
Skin reaction | Reading (hours) | Individual scores - rabbit number 1 -3 | ||
Erythema / eschar formation |
1 | 2 | 1 | 1 |
24 | 2 Br | 2 | 2 Br | |
48 | 2 Br | 2 | 2 Br | |
72 | 2 Br | 2 | 2 Br | |
7 Days | HyCrTL | HyTL | HyCrTL | |
14 Days | Fa | FaD | Fa | |
Oedema formation |
1 | 2 | 1 | 1 |
24 | 2 | 2 | 2 | |
48 | 2 | 2 | 2 | |
72 | 2 | 2 | 2 | |
7 Days | 0 | 0 | 0 | |
14 Days | 0 | 0 | 0 |
four hour exposure
Skin reaction | Reading (hours) | Individual scores - rabbit number 4 -6 | ||
Erythema / eschar formation | 1 | 2 H | 2 H | 2 H |
24 | 4 MBE | 4 EMB | 4 EMB | |
48 | 4 WBHE | 4 EMB | 4 EMB | |
72 | 4 WBE | 4 EWB | 4 EMB | |
7 Days | EHY | Eg | BsEgHy | |
14 Days | GsD | GsD | GsD | |
Total 24, 48 and 72 hours | 12 | 12 | 12 | |
Mean Values | 4 | 4 | 4 | |
Oedema formation | 1 | 4 0e | 4 0e | 3 |
24 | 4 0e | 4 0e | 4 0e | |
48 | 4 0e | 3 0e | 3 0e | |
72 | 3 | 3 | 3 | |
7 Days | 1 | 1 | 0 | |
14 Days | 0 | 0 | 0 | |
Total 24, 48 and 72 hours | 11 | 10 | 10 | |
Mean Values | 3,7 | 3,3 | 3,3 |
B = blanching of skin surrounding treatment site
Fa = abnormal fur growth - fur growing in various directions
Br= brown areas over treatment site
0e= oedema extending ventrally beyond site
D= desquamation
Hy= dry, straw-coloured skin (possible hyperkeratinisation)
Cr= superficial cracking of skin
T= thickening of skin
L= loss of skin suppleness
M= moderate to severe erythema extending beyond treatment site
W= well-definded erythe,a extending beyond treatment site
E= eschar of dry, straw-coloured sin (possible hyperkeratinsation) surrounding eschar
Eg= eschar lifting to reveal glossy skin
Bs= focal areas of dried, blood stained tissue
Gs= glossy skin
D= desquamation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- The test material was found to be corosive to rabbit skin under the conditions of the OECD 404 guideline.
- Executive summary:
Test material was subject to a test of skin irritancy according to OECD 404 guideline. 0.5 ml of substance were applied to the skin of six rabbits under semiocclusive conditions for 3 minutes and 1 h (3 animals) and 4 h (3 animals). The scoring of skin reactions was performed 1, 24, 48 and 72 h after end of exposure and after 7 and 14 days. Due to the severe effects on the exposed skin, the test item is classified as corrosive to the skin.
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