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EC number: 817-198-7 | CAS number: 1273322-47-6
- 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
Endpoint summary
Administrative data
Description of key information
No endpoint study is available for C16-18-(even numbered, C18-unsaturated)-alkylamines acetates. However, based on structural and functional similarities to the respective alkylamines an assessment based on read-across is possible. In GLP compliant studies according to GLP, coco- , tallow- , and oleyl alkylamines revealed skin corrosive properties. Based hereupon, the registration substance is considered to be corrosive to skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: fully air-conditioned rooms, seperate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat - Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3°C
- Humidity (%): 50 +- 20%
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: from 1984-11-20 to: 1984-12-11 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 4 hour / 1 hour and 3 minute exposure period
- Observation period:
- 30 - 60 min. after removal of the patches
24, 48 and 72 hrs after removal of the patches
7, 14, up to 21 days after removal of the patches - Number of animals:
- 9 (3 animals for 4 h exposure; 3 animals for 1 h exposure; 3 animals for 3 min exposure)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The moistened substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skin area (ca. 25 cm2) and then covered with a semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure:
animals #1-3: 3 min.
animals #4-6: 1 hr
animals #7-9: 4hrs
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 (lesion in depth).........4
Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4 - Irritation parameter:
- erythema score
- Basis:
- other: mean all animals
- Time point:
- other: 24h, 48h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- other: mean all animals
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- other: mean all animals
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 22
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Basis:
- other: mean all animals
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0.9
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- other: mean all animals
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: scare formation observed after 21 days
- Irritation parameter:
- edema score
- Basis:
- other: mean all animals
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: scare formation observed after 21 days
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testing of cocoalkylamines acetates for potential skin irritation/corrosion revealed scar formation after 21 days following a 4 hour exposure period but fully reversible findings following a 1 hour or a 3 minute exposure period. Based hereupon, cocosalkylamine acetates has to be labeled as corrosice category 1B.
- Executive summary:
Cocoalkylamine acetate was tested for skin irritation / corrosion according to OECD test guideline 404 in rabbits. Each animal was treated with 500 mg Cocoalkylamine acetate moistened with 0.4 mL isotonic saline and covered by semi-occlusive bandage. The exposure period was 3 min, 1 hour and 4 hours. After the exposure period all remnants were carefully removed from the skin with warm tap water. Readings were performed 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because effects were still present after 72 hours, additional readings were performed after 7 days 14 and 21 days.
After a contact time of 1 hour Cocoalkylamine acetate was irritating. There were clear localized erythema and slight edema. The surface of the skin was dry, brittle, with fine and coarse scales, parchment-like, chapped and light brown. After 21 days the skin had healed without scarring.
After a contact time of 4 hours, the treated skin became hardened, arched and green-brown to brown. From 14 days after removal of the patches, for the treated skin desquamation of coarse / fine scales causing scar and eschar formation was observed. The application sites were sharply defined against the surrounding skin . Due to the strong hardening of the skin erythema and edema formation could only be assessed at the surrounding skin of the application site, but not at the application site itself.
Based on these results, technically pure Cocoalkylamine acetate must be considered as corrosive to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no human data on skin and/or eye irritation available. However, in animals, data from all alkylamines demonstrated a significant dermal irritative potential of this chemical category. Tallow alkylamines as well as C12 -18 -(even numbered)-alkylamines and octadecenylamines were shown to be corrosive to rabbit skin, and, in consequence, not tested in rabbit eye. Based on close structural and functional similarities, it is assumed that C16 -18 -(even numbered, C18 -unsaturated)-alkylamines acetates will exhibit a comparable skin corrosive potential. In addition, C16 -18 -(even numbered, C18 -unsaturated)-alkylamines acetates is considered to also exhibit severe eye irritation potential.
Justification for selection of skin irritation / corrosion endpoint:
No study for skin irritation is available for the registration substance. However, based on data from analoguous primary alkylamines and alkylamines acetates skin corrosive potential has to be assumed.
Justification for selection of eye irritation endpoint:
No study for eye irritation is available for the registration substance. However, based on data from analoguous primary alkylamines a severe eye irritation potential has to be assumed.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Based on close structural and functional similarities, C16 -18 -(even numbered, C18 -unsaturated)-alkylamines acetates is considered to be corrosive to skin (category 1B). Based hereupon, no testing for eye irritation was performed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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