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EC number: 230-990-1 | CAS number: 7396-58-9
- 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:
- 30-09-1987 until 24-11-1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is GLP and according to guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see remarks below
- Principles of method if other than guideline:
- Three test animals were exposed for 3 min and 1 hour durations. Since no corrosive effects were observed another group of three rabbits was exposed for 4 hours.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Didecylamine
- EC Number:
- 214-312-1
- EC Name:
- Didecylamine
- Cas Number:
- 1120-49-6
- Molecular formula:
- C20H43N
- IUPAC Name:
- N-decyldecan-1-amine
- Details on test material:
- The test material was supplied by sponsor, as follows:
Description :colourless liquid
Container : glass screw-top bottle
Date of arrival : 7 september 1987
Storage conditions : room temperature
For the purpose of this study the test material used as supplied.
Test material data sheet available:
Batch/Lot no. : 1/84
Chemical name: N-methyl didecylamine
Flammability: > 100 C
melting point: ~ - 10 C
Specific gravity: 800 kg/m3
Stability: Unlimited at ambient temperature
Water solubility: very low
polar organic solvent: ethanol
non polar organic solvent: vegetable oil
Constituent 1
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, United Kingdom
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.21 - 3.16 kg
- Housing: individually in suspended metal cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21
- Humidity (%): 45 - 70
- Air changes (per hr): 15 changes/hour
- 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
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- 1 hr after removal of patches and 24, 48 and 72 hours later. Additional observations were made after 7 and 14 days.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: elasticated corset (tubigrip)
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.
- Time after start of exposure: 3 min, 1 hr and 4 hours
SCORING SYSTEM:
- According to Draize (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", see table below.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals 4 hrs exposure
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals 4 hrs exposure
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 2.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Three-mi nute Exposure
Very slight erythema was noted at two treated s k i n sites one hour after removal of the patches. Well-defined erythema had developed at all treated skin sites a t the 24-hour observation and well-defined or moderate t o severe erythema continued to be noted a t the 48 and 72-hour observations. Flaking, dry, - straw-col oured s k i n (possi ble hyperkeratinisation) was noted a t all treated skin s i t e s on days seven and fourteen. The reactions extended approximately 8 cm beyond one of the treated skin sites from the 72-hour observation onwards.
Very slight oedema was confined to one treated skin s i t e one hour after patch removal. Slight or moderate oedema had developed at all treated skin sites a t t h e 24-hour observation and slight oedema con-tinued to be noted at the 48 and 72-hour observations. The oedema extended beyond one treated s k i n s i t e a t the 24, 48 and 72-hour observations. No oedema was noted on days seven and fourteen.
One-hour Exposure
Very slight or well-defined erythema was noted at all treated skin sites one hour after removal of the patches. Well -defined or moderate to severe
erythema, w i t h areas of brown discolouration of the s k i n , were noted a t all treated s k i n sites at the 24, 48 and 72-hour observations. A brown dis-colouration of the skin and loss of skin suppleness were noted a t two treated s k i n sites on day seven. Flaking, dry, straw-coloured skin (possible hyperkeratinisation) was noted at the remaining treated skin site a t this time and a t all treated skin sites on day fourteen. The reactions extended approximately 8 to 10 cm beyond all treated s k i n sites during the observati on period.
Oedema, ranging from very slight to moderate was noted a t all treated skin sites one hour after patch removal. Severe oedema had developed a t all
treated s k i n sites at the 24-hour observation b u t the oedema decreased and was only slight a t the 72-hour observation. The oedema extended beyond all treated s k i n sites at the 24, 48 and 72-hour observations. No oedema was noted on days seven and fourteen.
Four-hour Exposure
The dermal reactions extended up to 8 cm beyond all treated skin sites during the observation period. Well-defined erythema was noted at at 7 treated skin sites one and 24 hours after removal of the patches. A slight haemorrhage of the dermal capillaries was noted at one treated skin site a t these observations. A brown discolouration of the s k i n was also noted at one treated skin site at the 24-hour observation. Well-defined or moderate to severe erythema was noted at all treated skin sites at the 48 and 72-hour observations. A green or brown discolouration of the skin was noted at two treated skin sites at these times, with transverse folding of the skin apparent at one treated skin site. On day seven dry, straw-coloured, flaking skin
( possi ble hyperkeratinisation) was noted at all treated skin sites. Small scattered scabs were also noted at two treated skin sites. Fissuring of the
skin, with signs of dried blood i n the fissures, was apparent at one treated skin site.
On day fourteen, glossy skin and reduced fur growth, w i t h or without desquamation, was noted at two treated s k i n sites. Fissuring, w i t h
associated small scattered scabs, and reduced fur growth were noted at the remaining treated skin site.
To establish reversibil ity of the dermal reactions an additional observation was made on day twenty-one. Glossy skin and reduced fur growth were noted at all treated skin sites. No evidence of corrosion was noted.
Slight or severe oedema was noted at all treated skin sites one hour after patch removal. Oedema ranging from very slight to moderate was noted at all treated skin sites at the 24, 48 and 72-hour observations. Very slight or slight oedema was noted at two treated skin sites on day seven. No oedema
was noted at the remaining treated skin site at this time or at any treated skin site on days fourteen or twenty-one.
Any other information on results incl. tables
Summary of dermal lesions (following 4-h application)
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
21 |
||||
48 |
Erythema/ eschar Oedema |
2 R 4 R |
2 BrR 3 R |
3 GrRTf 3 R |
3 GrRTf 3 R |
HyScR 2 R |
GsFrDR 0 |
GsFrR 0 |
2.7 |
3.0 |
92 |
Erythema/ eschar Oedema |
2 H 2 R |
2 HR 3 R |
3 BrR 2 R |
3 BrR 2 R |
HyFiScR 1 R |
FrFiScR 0 |
GsFrR 0 |
2.7 |
2.3 |
110 |
Erythema/ eschar Oedema |
2 2 |
2 R 3 R |
2 R 2 R |
2 R 2 R |
HyR 0 |
GsFrR 0 |
GsFrR 0 |
2.0 |
2.0 |
Mean |
2.5 |
2.4 |
Fa = abnormal fur growth; Fr = reduced fur growth; D = desquamation; T = thickening of skin; R= reactions extending beyond treatment site; Hy = hyperkeratinisation; Br = brown discolourisation of skin; L = loss of skin suppleness; H = haemorrhage of dermal capillaries; Gr = green discoulorisation of skin; Tf = transverse folding of skin; Fi = fissuring of skin; Sc = small scattered scabs; Gs = glossy skin
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The mean erythema and oedema score after 4 hr exposure was between 2.3 and 4.0 for two out of three animals.
Reversibility not completely shown within 21 days.
No signs of necrosis. - Executive summary:
A study was performed to assess the effects of Amine M210D on the irritancy potential to the skin of the New Zealand White rabbit. The method used was based on that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion".
A three minute, 1 hour and 4 hours, semi-occluded dermal application of the test material to the intact skin of three rabbits followed by a decontamination procedure with 3% (v/v) aqueous acetic acid followed by cotton wool in distilled water, produced irritation scores directly after patch removal and 1,2 and 3 days afterwards. The erythema/eschar effects were not fully reversible within 21 days, but the oedema effects were within 14 days. There was no evidence of visible necrosis.
The test material produced positive criteria for skin irritation following a four-hour exposure period in all rabbits.
The test material produced no evidence of visible necrosis following exposure periods of up to four hours.
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