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EC number: 270-418-8 | CAS number: 68439-75-8 This substance is identified by SDA Substance Name: C12-C18 dialkyl methyl amine and SDA Reporting Number: 16-043-00.
- 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:
- 26 September 1989 - 4 January 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- There is no information of Amines, di-C12-18-alkylmethyl (CAS No.: 68439-75-8; EC No.: 270-418-8) itself but there is information available for 1-Decanamine, N-decyl, N-methyl (CAS No.: 7396-58-9; EC No.: 230-990-1) which is structurally similar to Amines, di-C12-18-alkylmethyl.
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:
- N-methyldidecylamine
- EC Number:
- 230-990-1
- EC Name:
- N-methyldidecylamine
- Cas Number:
- 7396-58-9
- Molecular formula:
- C21H45N
- IUPAC Name:
- N-decyl-N-methyldecan-1-amine
- Test material form:
- liquid
- Details on test material:
- - Chemical name: N-decyl-N-methyldecan-1-amine
- EC number: 230-990-1
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree 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 housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimal 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated flank
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6, 4 females and 2 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch
- % coverage: -
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate s i r e 2.5 crn x 4.0 cm) . To
prevent the animals interfering with the patches and ingesting the test material the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test material removed by gentle swabbing with cotton wool soaked in water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale i.e. Draize J.H. (1959) Association o f Food and Drug Officials of the United States, Austin, Texas, "The Appraisal o f the Safety of Chemicals in Foods, Drugs and Cosmetics". See below:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Severe dermal responses were produced. The adverse skin reaction sometimes precluded accurate evaluation of erythema and oedema. Very slight to well-defined erythema with or without very slight oedema was noted one hour after patch removal. The responses increased in severity and at subsequent observations were identified as well -defined erythema, very slight to moderate oedema, blanching of the skin, haemorrhage of the dermal capillaries, a white exudate, white raised areas of skin, thickening of the skin, scabbing, fissuring, a dry straw-coloured crust (possible hyperkeratinisation), reduced re-growth of fur, glossy skin and desquamation. No corrosive effects were noted.
Any other information on results incl. tables
Results table:
Rabbit No and sex |
Region of the eye |
Hours after instillation |
Average 24-48-72 hours |
|||||
1 |
24 |
48 |
72 |
7 |
14 |
|||
2 m |
erythema |
1R |
2 RBl |
2 HdRBlW |
2 HdRBlW |
?eThF iRSp |
?eHyRSs |
2 |
oedema |
0 |
3 Oe |
2 R |
2 R |
?0d |
0 |
2.3 |
|
5 f |
erythema |
2R |
2R |
2 RBlWEx
|
2 RBlWEx |
?eThSkSp |
?eHyRSs |
2 |
oedema |
1 |
2 |
2 R |
2 R |
?0d |
0 |
2 |
|
9 f |
erythema |
2R |
2R |
2 RBlWEx |
?eBlWE |
?eThFiRSp |
?eHyRFr |
2 |
oedema |
1 |
1 |
1 R |
1 R |
?0d |
0 |
1 |
|
12 f |
erythema |
1R |
2RBl |
?eRBIWWe |
?eRBlWExWe |
?eThSkRSpp |
?eDRFr |
2 |
oedema |
0 |
2 |
2 R |
2 R |
?0d |
0 |
2 |
|
21 m |
erythema |
2R |
2HdR |
2 HdBlWR |
2 HdBlWR |
?eThRSp |
?eDRFr |
2 |
oedema |
1 |
3 Oe |
2 R |
2 R |
?0d |
0 |
2.3 |
|
22 f |
erythema |
1R |
2R |
2 RBlW |
2 RBlW |
?eThFiRSp |
?eRHyGFr |
2 |
oedema |
0 |
3 Oe |
2 R |
2 R |
?0d |
0 |
2.3 |
Hd - General ised areas of slight haemorrhage of the dermal capillaries
(release of small amounts of blood into surrounding dermal tissue)
R - Dermal reactions extend beyond sit e of test material application
Bl - Blanching of the skin
W - White raised areas of skin
We - Well-defined erythema surrounding other adverse dermal reactions
Th - Thickening of the skin
Ex - Exudate
St - Hardened, dark brown/black-colored scab
?e - Unable to evaluate degree of erythema due to presence of other adverse dermal responses
Hy - Dry, straw-coloured crust, sometimes flaking from the skin
(possible hyperkeratinisation)
G - Skin glossy in appearance (keratinolysis)
Fr - Reduced re-growth of fur
Sp - Light brown-coloured scab
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to the results from this study 2 animals had a erythema or oedema score ≥ 2.3 and after 14 days the erythema score could not be read. The oedema score was fully reversible. Therefore "Cesio 28" is classified as irritating to skin (Category 2) under GHS.
- Executive summary:
An acute dermal irritation/corrosion study was performed in rabbits (4 females and 2 males) according to OECD 404 and under GLP. Severe dermal responses were produced. The adverse skin reaction sometimes precluded accurate evaluation of erythema and oedema. Very slight to well-defined erythema with or without very slight oedema was noted one hour after patch removal. The responses increased in severity and at subsequent observations were identified as well -defined erythema, very slight to moderate oedema, blanching of the skin, haemorrhage of the dermal capillaries, a white exudate, white raised areas of skin, thickening of the skin, scabbing, fissuring, a dry straw-coloured crust (possible hyperkeratinisation), reduced re-growth of fur, glossy skin and desquamation. No corrosive effects were noted. According to the results from this study 2 animals had a erythema or oedema score ≥ 2.3 and after 14 days the erythema score could not be read. The oedema score was fully reverible. Therefore "Cesio 28" is classified as irritating to skin (Category 2) under GHS.
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