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EC number: 247-361-2 | CAS number: 25952-53-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 July 2017 to 18 July 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- EC Number:
- 247-361-2
- EC Name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- Cas Number:
- 25952-53-8
- Molecular formula:
- C8H17N3.ClH
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-N'-ethylcarbodiimide hydrochloride
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Appearance: White crystalline powder
Batch: AAN0680
Purity/Composition: 99.9 %
Test item storage: At room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes were used as soon as possible after slaughter. Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, -'s Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750ul of a 20% (w/v) solution of 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride prepared in physiological saline was administered
- Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 240 +/-10 minutes at 32 +/-1 degreesC
- Duration of post- treatment incubation (in vitro):
- After the incubation the solutions were removed and the epithelium was washed at least three times with MEM with phenol red (Earle’s Minimum Essential Medium Life Technologies). Possible pH effects of the test item on the corneas were recorded
- Number of animals or in vitro replicates:
- 3 replicates
- Details on study design:
- The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine
(Life Technologies) and 1% (v/v) Fetal Bovine Serum (Life Technologies)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen,
Germany) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 1C. The corneas were incubated for the minimum of 1 hour at 32 +/- 1 deg C.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 24
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Value:
- 24
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Permeability
- Value:
- 0.007
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 123 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride induced ocular irritation through one endpoint (opacity) only, resulting in a mean in vitro irritancy score of 24 after 240 minutes of treatment.
1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride induced an IVIS > 3 ≤ 55, no prediction on the classification can be made. - Executive summary:
The objective of this study was to evaluate the eye hazard potential of 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test). This report describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride was tested through topical application for approximately 240 minutes. The study procedures described in this report were based on the most recent OECD guideline. Batch AAN0680 of 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride was a white crystalline powder with a purity of 99.9%. The test item was applied as a 20% (w/v) solution (750 µl) directly on top of the corneas. The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 123 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride induced ocular irritation through one endpoint (opacity) only, resulting in a mean in vitro irritancy score of 24 after 4 hours of treatment. In conclusion, since 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
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