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EC number: 812-745-6 | CAS number: 205041-15-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2020-04-21 to 2020-05-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- adopted 09th October 2017
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (prop-2-en-1-yl)({3-[(prop-2-en-1-yl)amino]propyl})amine dihydrochloride
- EC Number:
- 812-745-6
- Cas Number:
- 205041-15-2
- Molecular formula:
- C9 H20 Cl2 N2
- IUPAC Name:
- (prop-2-en-1-yl)({3-[(prop-2-en-1-yl)amino]propyl})amine dihydrochloride
- Test material form:
- solid
- Details on test material:
- - CAS: 205041-15-2
- Batch: LWDDP00072
- Colour: white
- Purity (GC): 100%
- Expiry date: 2020-08-11
- Storage conditions: room temperature
- Stability: stable under recommended storage conditions
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was tested as supplied.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
Corneas of calves aged les than 8 months were collected in the slaughterhouse of Sobeval Boulazac 24759 - France, in a short time after slaughtering of the animals and transported in a Hanks´s buffered saline solution with antibiotic to the laboratory.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 ± 75 mg - Duration of treatment / exposure:
- 4 hours at 32 +/- 1 °C
- Duration of post- treatment incubation (in vitro):
- The permeability at 490 nm was measured upon 90 minutes of incubation with fluorescein after exposure to the test item by using a spectrophotometer.
- Number of animals or in vitro replicates:
- Three corneas each for the test item, negative control and positive control.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- At reception, calve eyes were carefully examined under lighting and these showing a visble defect were eliminated. For each selected eye, an incision with a scalpel was practiced at the level of the scleral ring by means of scissors. Approximately 2 to 3 mm of scleral ring were left to facilitate the further handlings. Corneas were immersed in Hanks' medium at room temperature. For mounting, the corneas were deposited, endothelial side upwards on the posterior part of cornea holders. Then the anterior part was firmly clamped in place with 3 screws. The anteroir (epithelial side) and posterior (endothelial side) compartments were then filled with pre-warmed EMEM without phenol and ensuring that no bubbles were formed. The corneas were incubated for one hour at 32 +/- 1 °C.
INITIAL OPACITY and CORNEA SELECTION
- After pre-incubation, compartments were emptied and fresh EMEM was added. The opacity at t=0 (OPT0) was then determined. Corneas showing a value of opacity greater than seven opacity units were discarded.
NUMBER OF REPLICATES
- 3 corneas for test item, 3 corneas for negative control and 3 corneas for the positive control
NEGATIVE CONTROL USED
- 0.9% NaCl, Cooper batch 13NLP271
POSITIVE CONTROL USED
- Imidazole, diluted at 20% with 0.9% NaCl, Sigma batch: SLBTZ469
APPLICATION DOSE AND EXPOSURE TIME :
- 750 ± 75 mg for 4 hours
TREATMENT METHOD: open chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the end of the exposure period, the test item and controls were removed from the anterior compartment and the epithelium washed at least three times (or until no visual evidence of test item can be observed) with EMEM containing phenol red. After the last effective rinsing, corneas were given a final rinse with EMEM without phenol red, what allowed to make sure that the inside of support was cleared of any phenol red before the next measure of opacity.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacity was determined by the amount of light transmission through the cornea. Corneal opacity was measured quantitatively with the aid of an opacitometer (OP-KIT), resulting in opacity values measured on a continuous scale. The opacity of each cornea was measured at 2 times, just before treatment with the test item (OPT0) and immediately after the end of the exposure period (OPT2)
- Corneal permeability: Passage of sodium fluorescein dye measured with the aid of a spectrophotometer (software VISION lite(TM) version 2.2) (OD490) . The assessment of this parameter was performed after the 2nd opacity measurement.
- Other: Corneas were observed and visible modifications of the cornea (oedema, colouring) were noted.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) (mean opacity value + (15 x mean permeability OD490 value))
DECISION CRITERIA: The decision criteria as indicated in the TG were used (see Table 1 in box "Any other information on materials and methods incl. tables).
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of triplicates
- Value:
- 10.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no prediction can be made
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: epithelium detachment
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the test was considered acceptable if the negative control gave opacity values OP < 12 and the optical density OD < 0.140. They were respectively: OP = 0.7 and OD = 0.004.
- Acceptance criteria met for positive control: yes, the test was considered acceptable if the positive control gives an IVIS that ranged within two standard deviations of the current historical mean (80.3 < IVIS < 179.3) (Result: 133.2 ± 12.0).
Any other information on results incl. tables
Table 2: Results of the main experiment
4 h treatment | ||||||||
Support Nos | Treatment | Opt0 | Opt2 | Opt2-Opt0 | adjusted opacity | OD | OD adjusted | Score (Opa+15xODa) |
26 | Negative control NaCl 0.9%, | 2 | 3 | 1 | 0 | 0 | 0 | |
7 | 4 | 2 | -2 | 0.006 | 0.006 | 0.1 | ||
18 | 0 | 3 | 3 | 0.007 | 0.007 | 0.1 | ||
Observations: - | Mean | 0.7 | 0.004 | 0.004 | 0.1 | |||
SD | 2.5 | 0.004 | 0.004 | 0.1 | ||||
Support Nos | Treatment | Opt0 | Opt2 | Opt2-Opt0 | adjusted opacity |
OD | OD adjusted |
Score (Opa+15xODa) |
4 | Positive control Imidazol | 0 | 90 | 90 | 89.3 | 2.418 | 2.414 | 125.5 |
27 | 0 | 115 | 115 | 114.3 | 2.186 | 2.182 | 147.1 | |
15 | 0 | 90 | 90 | 89.3 | 2.51 | 2.506 | 126.9 | |
Observations:Oedema and high epithelium detachment | Mean | 97.7 | 2.367 | 133.2 | ||||
SD | 14.4 | 0.167 | 12 | |||||
Support Nos | Treatment | Opt0 | Opt2 | Opt2-Opt0 | adjusted opacity | OD | OD adjusted | Score (Opa+15xODa) |
22 | N1,N3-diallylpropane-1,3-diamine dihydrochloride | 0 | 11 | 11 | 10.3 | 0.066 | 0.062 | 11.3 |
13 | 0 | 14 | 14 | 13.3 | 0.158 | 0.154 | 15.6 | |
12 | 2 | 6 | 4 | 3.3 | 0.125 | 0.121 | 5.1 | |
Observations:Epithelium detachment |
Mean | 9 | 0.112 | 10.7 | ||||
SD | 5.1 | 0.047 | 5.3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No prediction can be made
- Conclusions:
- In conclusion, based on the mean in vitro irritation score of 10.7 obtained in the bovine corneal opacity and permeability assay (BCOP, OECD 437), no prediction can be made regarding the classification of the test substance.
- Executive summary:
The eye irritation potential of N1,N3-diallypropane-1,3-diamine dihydrochloride (100% purity) was investigated in the bovine corneal opacity and permeability assay (BCOP, OECD 437). A mean in vitro irritation score of 10.7 was determined. The positive and negative controls induced the appropriate responses, indicating the validity of the assay. Based on the results obtained, no prediction can be made regarding the classification of the substance.
The study is acceptable and satisfies the guideline requirements for an in vitro study for eye damage (OECD 437).
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