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EC number: 268-957-9 | CAS number: 68155-37-3 This substance is identified by SDA Substance Name: N-C12-C18 alkyl propylene diamine and SDA Reporting Number: 16-032-00.
- 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:
- 2007-11-16 to 2008-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, N-C12-18-alkyltrimethylenedi-
- EC Number:
- 268-957-9
- EC Name:
- Amines, N-C12-18-alkyltrimethylenedi-
- Cas Number:
- 68155-37-3
- Molecular formula:
- R-NH-(CH2)3-NH2
- IUPAC Name:
- N-C12-18-alkyl-propane-1,3-diamine
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): N-Coco-1,3-diaminopropane
- Physical state: liquid
- Composition of test material, percentage of components:
Total Primary amines: 8.3 %
Total Diamines: 91.7 %
Iodine number: 12 g I/100g
Water: 0.28 % (0-1 %)
C8 N Primary amine: 0.3 %
C10 N Primary amine: 0.5 %
C12 N Primary amine: 4.2 %
C14 N Primary amine: 1.6 %
C16 N Primary amine: 0.9 %
C18:1 N Primary amine: 0.6 %
C18:0 N Primary amine: 0.2 %
C8 Diamine: 4.0 %
C10 Diamine: 5.3 %
C12 Diamine: 45.5 %
C14 Diamine: 16.5 %
C16 Diamine: 9.5 %
C18:1 Diamine: 7.5 %
C18:0 Diamine: 3.6 %
Acrylnitrile: <4 ppm
Fatty acids: <1 %
Fatty alkyl nitriles: <1 %
- Purity test date: 2007-10-15
- Lot/batch No.: S000903
- Expiration date of the lot/batch: 2010-09-30
- Storage condition of test material: at RT
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand White HsdIf:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 2.4 to 2.5kg
- Housing: in ABS - plastic rabbit cages, floor 4200cm²
- Diet (e.g. ad libitum): free access to Altromin 2123 maintenance diets for rabbits, rich in crude fibre
- Water (e.g. ad libitum): free access to tap water (microbiologically controlled periodically)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +- 3°C
- Humidity (%): 55 +- 10%
- Air changes (per hr): at least 10x/h
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- other: initial test: gauze patch was held in place with a semiocclusive dressing; additional test: patch was held manually in place
- Preparation of test site:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin areas of the test animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL - Duration of treatment / exposure:
- initial test: 4h
additional test: 3min - Observation period:
- 1, 24, 48, 72h after patch removal (for both tests)
- Number of animals:
- 1 animal for each both test
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: small area of approximately 6cm²
REMOVAL OF TEST SUBSTANCE
initial test:
- Washing (if done): rinsed by using tap water
- Time after start of exposure: at the end of the exposure period
additional test:
Test substance was not rinsed.
SCORING SYSTEM:
according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: PSI
- Basis:
- animal #1
- Remarks:
- initial test (exposure: 4h)
- Time point:
- other: average over 24/48/72h
- Score:
- 8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72h
- Remarks on result:
- other: Necrosis covering the entire patch was observed at all times
- Irritation parameter:
- other: PSI
- Basis:
- animal #2
- Remarks:
- additional test (exposure: 3min)
- Time point:
- other: average over 24/48/72h
- Score:
- 8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72h
- Remarks on result:
- other: Black necrosis covering the entire patch area was observed at all times
- Irritant / corrosive response data:
- Dermal irritation was scored and recorded according to the grades stated in the guidelines. Due to the severe reactions and animal welfare the animals were euthanized shortly after the last observation.
- Other effects:
- Necrosis was observed, refer to Table 1.
Any other information on results incl. tables
Table 1: Dermal irritation of animal 1 and 2
|
1h |
24h |
48h |
72h |
||||
Animal number |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
1 |
4* |
4 |
4* |
4 |
4* |
4 |
4* |
4 |
2 |
1 |
2 |
4* |
4 |
4* |
4 |
4* |
4 |
* necrosis covering the whole patch area
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to the criteria of the Commission Directive 2001/59/EC, the test item N-Coco-1,3-diaminopropane has to be classified as corrosive.
- Executive summary:
Acute dermal irritation/corrosion of N-Coco-1,3 -diaminopropane was investigated by administration of 0.5mL unchanged test substance. In the initial test, one female New Zealand White (NZW) rabbit was exposed 4h after removing fur from the dorsal area of the trunk. At the end of the exposure period, residual test substance was rinsed by using tap water. The animal was examined for signs of erythema and oedema at 1, 24, 48, 72h after patch removal. An additional test was requested by the sponsor. Therefore, another female NZW rabbit was exposed to the unchanged test substance for 3min. Residual test substance was not rinsed and the effects were also observed after 1, 24, 48 and 72h.
Calculation of Primary Irritation Scores (PIS) as an average value over 24h, 48h and 72h was calculated for each animal. This yielded a value of 8 for both tests. Necrosis covering the entire patch was observed at all times. These severely irritant effects were not reversible within 72h after patch removal. The animal of the initial test also showed weight loss during the observation period.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 2001/59/EC) the test item N-Coco-1,3-diamonipropane has to be classified as corrosive.
The test on acute dermal irritation/corrosion was performed under GLP and similar to guideline OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500 without deviations.
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