Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 273-282-8 | CAS number: 68955-56-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 - 18 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No 8147, April 2011, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, C36-alkylenedi-
- EC Number:
- 273-282-8
- EC Name:
- Amines, C36-alkylenedi-
- Cas Number:
- 68955-56-6
- Molecular formula:
- Not applicable UVCB substance
- IUPAC Name:
- (1E,19E)-10,11-dioctylicosa-1,19-diene-1,20-diamine
- Test material form:
- other: Slightly viscous amber liquid
- Details on test material:
- - Name of test material (as cited in study report): Amines, C36-alkylenedi-
- Substance type: Slightly viscous amber liquid
- Physical state: liquid
- Purity: 98.2%
- Lot/batch No.: 0000436391
- Expiration date of the lot/batch: 24 January 2021
- Storage condition of test material: At room temperature in the dark under nitrogen
- pH (1% in water, indicative): 9.9
- Volatile: No
- Test substance handling: Flush container with nitrogen after handling
- Solubility in Water: No
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Animal used within the study was at least 6 weeks old
- Weight at study initiation: Body weight was at least 1.0 kg
- Housing: Animal was housed individually in cage with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Italy). Hay and wooden sticks were abailable during the study period.
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Temporary deviations from the minimum level of daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations.
IN-LIFE DATES: From: 04 - 18 June 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- Single application.
- Observation period:
- 14 days.
- Number of animals:
- one male
- Details on study design:
- STUDY DESIGN
The study was performed in a stepwise manner and started with the treatment of one animal (sentinel) with a stepwise exposure regime. Based on the severity of the skin reactions, no further animals were exposed.
TEST SUBSTANCE PREPARATION
The test substance was applied undiluted as delivered by the sponsor.
TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
The test substance was applied to the skin of one flank, using a Metalline patch of 2x3 cm.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water and ethanol.
OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to application) and after the final observation.
- Necropsy: No necropsy was performed according to protocol.
- Irritation: The skin reactions of all visible treated sites were assessed immediately after removal of a dressing and approximately 1, 24, 48, 72 hours after the removal of the last dressing and test substance. For the duration of the skin reactions, further observations were made 7 and 14 (maximum)
days after exposure. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of untreated skin of the animal served as controls.
SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours.
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours.
- Score:
- 3
- Max. score:
- 4
- Irritant / corrosive response data:
- Irritation: A 3-minute, 1-hour and 4-hour exposure resulted in erythema (maximum grade 4 (severe)) and oedema (maximum grade 2 (slight) to 4 (severe)), which had resolved within 14 days following exposure. Superficial brown discoloration (a sign of necrosis) and superficial fissuring of the skin were noted at 7 days after exposure, and bald skin (bald and shiny after a 1- and 4-hour exposure) and scaliness were noted at 14 days after exposure. At 7 days after a 1- and 4-hour exposure, skin reactions could not be scored due to fissuring and brown discolouration (a sign of necrosis; due to which a maximum grade 4 was given for erythema).
Corrosion: There was no evidence of a corrosive effect on the skin. - Other effects:
- Coloration/remnants: On the skin exposed to the test substance for 1 and 4 hours, remnants of the test substance were present, being sticky on Day 1, and 24, 48 and 72 hours after exposure, and dry at 7 days after exposure. This did not hamper the scoring of the skin irritation reactions.
Toxicity/mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of Amines, C36-alkylenedi- to the intact rabbit skin. The extreme response following a 4-hour exposure to Amines, C36-alkylenedi- in a single animal was irreversible within the 14-day observation period.
Based on these results and according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007), Amines, C36-alkylenedi- should be classified as : skin irritant (Category 2).
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, Amines, C36-alkylenedi- should be classified as Irritant (Category 2) and labeled as H315: Causes skin irritation. - Executive summary:
Primary skin irritation/corrosion study with AMINES, C36-ALKYLENEDI- in the rabbit (semi-occlusive application). The study was carried out based on the guidelines described in:
OECD No.404 (2002); "Acute Toxicity - Skin irritation"
EC, No 440/2008; B4: "Acute Toxicity: Dermal Irritation/Corrosion"
US EPA, OPPTS 870.2500 (1998), Acute Dermal Irritation
JMAFF Guidelines (2000) including the most recent partial revisions.
One rabbit was exposed to three samples of 0.5 mL of AMINES, C36-ALKYLENEDI- applied to separate skin-sites on intact, clipped skin using a semi-occlusive dressing. The exposure periods were 3 minutes, 1 hour and 4 hours, respectively. Skin reactions were assessed at least once daily for 4 days after exposure and 7 and 14 days after exposure. Based on the severity of the skin reactions, no further animals were exposed.
A 3-minute, 1-hour and 4-hour exposure resulted in erythema (maximum grade 4 (severe)) and oedema (maximum grade 2 (slight) to 4 (severe)), which had resolved within 14 days following exposure. Superficial brown discoloration (a sign of necrosis) and superficial fissuring of the skin were noted at 7 days after exposure, and bald skin (bald and shiny after a 1- and 4-hour exposure) and scaliness were noted at 14 days after exposure.
At 7 days after a 1- and 4-hour exposure, skin reactions could not be scored due to fissuring and brown discolouration (a sign of necrosis; due to which a maximum grade 4 was given for erythema).
There was no evidence of a corrosive effect on the skin.
On the skin exposed to the test substance for 1 and 4 hours, remnants of the test substance were present, being sticky on Day 1, and 24, 48 and 72 hours after exposure, and dry at 7 days after exposure. This did not hamper the scoring of the skin irritation reactions.
No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of Amines, C36-alkylenedi- to the intact rabbit skin.
The extreme response following a 4-hour exposure to Amines, C36-alkylenedi- in a single animal was irreversible within the 14-day observation period.
Based on these results and according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007), Amines, C36-alkylenedi- should be classified as : skin irritant (Category 2).
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, Amines, C36-alkylenedi- should be classified as Irritant (Category 2) and labeled as H315: Causes skin irritation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.