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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 254-754-2 | CAS number: 40027-38-1
- 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:
- 01 August 2018 - 02 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
- Version / remarks:
- November 2000, including the most recent revisions.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine
- EC Number:
- 254-754-2
- EC Name:
- Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine
- Cas Number:
- 40027-38-1
- Molecular formula:
- C21H44N2xC18H34O2
- IUPAC Name:
- oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine
- Test material form:
- solid
- Details on test material:
Substance Name: N-(Oleyl alkyl)- 1,3-propanediamine mono oleate
CAS: 40027-38-1
Lot/Batch: P15-005
Appearance: Yellow paste at 20°C
Test item storage: At room temperature
Date of Production: 2015-02-18
Best before Date: 2020-02-18
Trade Name: Armolube 211
mp 30-40°C
D = 880 kg/m³ at 40°C
m.form. C39H78N2O2
mw 607.065
Purity: UVCB
Purity test date: 24 April 2018
Constituent 1
- Specific details on test material used for the study:
- - No correction was made for the purity/composition of the test item.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle, France
- Age at study initiation: A young adult animal (approximately 22 weeks old)
- Weight at study initiation: 3942 g
- Housing: individually in a labeled cage with perforated floor
- Diet: pelleted diet for rabbits (Global Diet 2030 Teklad, Mucedola, Milanese, Italy), provided once daily. In addition, hay was available during the study period.
- Water: municipal tap-water, available ad libitum
- Acclimation period: the animal was allowed to acclimate for at least 5 days before commencement of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 56 to 82%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 August 2018 - 02 August 2018
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
NEGATIVE CONTROL: adjacent areas of the untreated skin - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- 4 days
- Number of animals:
- 1 male animal (no further animals were treated, after considering the degree of skin reaction observed in the first animal).
- Details on study design:
- The animal was initially exposed to the test item for 3 minutes to consider whether exposure could be continued humanely. Subsequently, the animal was exposed to a 1-hour and a 4-hour exposure period using an identical procedure but two seperate skin-sites.
TEST SITE
- Area of exposure: dorsal area, 150 square centimeters (10 x 15 cm)
- % coverage: not indicated
- Type of wrap if used: Micropore tape, wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: after removing of each dressing, the skin was cleaned with tap water.
- Time after start of exposure: three minutes, one hour and four hours
OBSERVATION TIME POINTS:
- Post dose observations: immediately after removal of the dressing and 1 and 24 hours after test item removal.
SCORING SYSTEM: Draize
- Method of calculation: visual scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- due to necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- - No severe skin reactions were noted immediately after an exposure period of three minutes or 1 hour and therefore the third bandage was kept on the skin for an exposure of 4 hours. One day after exposure, the 4 hours treatment resulted in an erythema score of 4. Oedema was scored 1 hour after the bandage was removed resulting in a score of 4, oedema could not be scored one day after exposure due to destruction of the skin.
- Full thickness destruction (noted as brown necrosis) was noted for all treated skin areas on the day after dosing.
- Sticky remnants of the test item were present on the 3 minutes treatment site on day 1
- No signs of systemic toxicity during the study period were observed and no mortality occured
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Category 1B according to Regulation (EC) No 1272/2008.
- Conclusions:
- Based on the results of an in vivo skin irritation study, performed according to OECD 404 and GLP principles, N-(Oleyl alkyl)-1,3-propanediamine mono oleate is classified as Category 1B (corrosive) according to GHS and Regulation (EC) 1272/2008.
- Executive summary:
The possible irritation or corrosion potential of a single dose of Armolube 211 administered to the intact skin of rabbit was evaluated in a primary skin irritation study carried out based on the guidelines described in OECD 404 (2015)/OPPTS 870.2500 (1998)/JMAFF Guidelines (2000). One rabbit was exposed to three samples of 0.5 grams of Oleyl-diamine mono-oleate 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 on the day of dosing (Day 1) and Day 2. Based on the severe skin reactions, no further animals were exposed.
On the day of dosing, up to grade 2 erythema and grade 4 edema was noted for all treated skin sites. Necrosis was noted for all treated skin areas on the day after dosing.
It is concluded that Oleyl-diamine mono-oleate is corrosive to the skin should be classified as skin corrosive Category 1B under GHS. (CLP: Corrosive Category 1B; H314: Causes severe skin burns and eye damage.)
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.