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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-924-6 | CAS number: 18016-43-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine
- EC Number:
- 241-924-6
- EC Name:
- Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine
- Cas Number:
- 18016-43-8
- Molecular formula:
- C38H69N3O – C58H111N3O3
- IUPAC Name:
- (9Z)-octadec-9-enoic acid; bis(2-aminoethyl)amine
- Details on test material:
- - Name of test material (as cited in study report): Oleic acid, compound with N-(2- aminoethyl)ethane-1,2-diamine
- Physical state: liquid
- Analytical purity: Reaction product of Oleic acid and N-(2-aminoethyl) ethane-1,2-diamine: elemental analysis yielded 100.4 g/100 g; "Triamide"-content: 5.2 g/100 g (HPLC analysis)
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: Approx. 5-7 months
- Weight at study initiation: 4.05 kg – 4.92 kg
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD 404 guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 2.9
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: necrosis was not observed, individual mean scores: 2.7 in 1/3 animals, 3.0 in 2/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: mean individual scores: 4 in 3/3 animals
Any other information on results incl. tables
In two out of three animals well-defined erythema (grade 2) was observed directly after removal of the patch and increased to moderate erythema (grade 3) in one of these animals after one hour. From 24 hours until day 7 moderate erythema was noted in
these two animals and decreased to well-defined (grade 2) or very slight (grade 1) erythema at day 14, respectively. In the third animal well-defined erythema was observed from 1 hour until 24 hours after removal of the patch; thereafter moderate
erythema was noted from 48 hours until study day 7 and decreased to well-defined erythema at day 14. In all three animals erythema was noted beyond the application site from 24 hours until study day 7 or 14, respectively.
In one animal slight edema (grade 2) was noted directly after removal of the patch; one hour later slight edema was still observed in this animal. The other two animals showed very slight (grade 1) or severe (grade 4) edema 1 hour after removal of the patch. 24
hours after removal of the patch severe edema was noted in all animals and persisted until 72 hours in two animals or study day 7 in one animal. In two out of three animals slight or moderate edema was noted on study day 7; in one of these animals very slight
edema was still observed on study day 14. The third animal also showed very slight edema on study day 14. In two out of three animals edema beyond the application site was noted from hour 24 until day 7.
Yellowish or brown-yellowish discoloration of the application area was noted in all animals from 24 hours until 72 hours after removal of the patch. In two out of three animals crusty secretion was also seen during this observation period; while plate-like
incrustations were noted in all three animals at 72 hours or on study day 7, respectively. Thereafter, on day 7 or day 14 the plate-like incrustations dropped off and revealed underneath either petechiae and scaling or pink-colored skin with or without
scaling. In one of these animals scaling was noted during the whole observation period (except day 7) until day 14.
The cutaneous reactions were not reversible in all three animals within 14 days after removal of the patch. Slight or well-defined erythema and/or very slight edema were still present at study termination, in one animal in addition to scaling.
Necrosis of the skin was not evident during the course of the study.
Mean scores over 24, 48 and 72 hours for each animal were 3.0, 3.0 and 2.7 for erythema and 4.0, 4.0 and 4.0 for edema.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.