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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-823-7 | CAS number: 74-94-2
- 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:
- key study
- Study period:
- 2017-02-24 to 2017-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dimethylamine-borane (1:1)
- EC Number:
- 200-823-7
- EC Name:
- Dimethylamine-borane (1:1)
- Cas Number:
- 74-94-2
- Molecular formula:
- C2H10BN
- IUPAC Name:
- N-Methylmethanamine-borane (1:1)
- Test material form:
- solid: crystalline
- Details on test material:
- CAS: 74-94-2
Description: white crystalline solid
Batch No.: 1609024
Purity: 99.33 %
Expiry Date: 14 Sep 2017
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: +5 °C, protected from light
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: The test item was suspended with physiological saline 0.9% NaCl (Alleman Pharma, lot no. 609709, expiry date: 2017-03-03) to give a 20% concentration, afterwards it was vortexed prior to administration.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES:
- The assay uses isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany. On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20%
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): physiological saline 0.9% NaCl
- Lot/batch no. (if required): Alleman Pharma, lot no. 609709 - Duration of treatment / exposure:
- 4 hours ± 5 minutes at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- The optical density 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 (physiological saline 0.9% NaCl) and positive control (imidazole 20% in physiological saline 0.9% NaCl).
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- The assay uses isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany.
On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.
The eyes were carefully examined for defects and any defective eyes were discarded.
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before the corneas were mounted in corneal holders (Duratec GmbH) with the endothelial side against the O-ring of the posterior chamber, they had been visually examined for defects and any defective cornea had been discarded. The anterior chamber was then positioned on top of the cornea and tightened with screws. The chambers of the corneal holder were then filled with RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always filled first. The corneas were incubated for one hour at 32 1 °C.
TREATMENT METHOD: closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Washing with MEM containing phenol red until the medium was free of test substance (at least 3 times), then completely rinsed with RPMI without phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: After the equilibration period, the medium was removed from both chambers and replaced with fresh complete RPMI. An initial measurement was performed on each of the corneas using the opacitometer. Three corneas with illuminance readings approximately equivalent to the median illuminance of all corneas were selected as negative-control corneas. The illuminance of each cornea was read and recorded. Only corneas that had an initial illuminance reading I > I0/1.1651 lux were used for the assay. The medium was removed from the anterior chamber and replaced with the test item or control. After the 4 hours incubation period and subsequent washing the anterior chamber was refilled with complete RPMI and an illuminance measurement was performed. Also, each cornea was observed visually and pertinent observations were recorded. After the illuminance measurement was performed, the medium was removed from both chambers of the holder.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490):
After the illuminance measurement was performed, the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh complete RPMI. 1 mL of a 5 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 +/-1 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer (Jenway 6405 UV/VIS).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
IVIS = mean opacity value + (15 x mean permeability OD490 value)
The IVIS cut-off values for identifying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given in Table 1 (see "Any other information on materials and methods").
An identification of test substances that should be classified as irritating to eyes (UN GHS Category 2 or Category 2A) or test substances that should be classified as mildly irritating to eyes (UN GHS Category 2B) cannot be made.
For this purpose further testing with another suitable method is required
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 101.13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control responses should result in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
- Acceptance criteria met for positive control: The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid
Any other information on results incl. tables
Table 2: Opacity
Cornea No. | Test Item | Initial Opacity | Final Opacity | Change of Opacity Value | Corrected Opacity Value |
1 | Negative Control Physiological Saline |
2.01 | 2.46 | 0.54 | |
2 | 2.23 | 2.62 | 0.38 | ||
3 | 1.75 | 3.32 | 1.58 | ||
MV | 2.00 | 2.80 | 0.80 | ||
4 | Positive Control 20% Imidazol in physiological saline |
2.54 | 105.91 | 103.36 | 102.56 |
5 | 2.54 | 101.87 | 99.33 | 98.52 | |
6 | 2.66 | 84.64 | 81.98 | 81.18 | |
MV | 2.58 | 97.47 | 94.89 | 94.09 | |
7 | Test Item dimethylamine-borane (20% in physiological saline) |
1.60 | 24.25 | 22.65 | 21.84 |
8 | 0.32 | 60.75 | 60.43 | 59.63 | |
9 | 0.88 | 42.62 | 41.74 | 40.94 | |
MV | 0.93 | 42.54 | 41.61 | 40.80 |
Table 3: Permeabilty
Cornea No. | Test Item | OD490 | Corrected OD490 |
1 | Negative Control Physiological Saline |
0,007 | |
2 | 0,009 | ||
3 | 0,018 | ||
MV | 0,011 | ||
4 | Positive Control 20% Imidazol in physiological saline |
3,060 | 3,049 |
5 | 4,660 | 4,649 | |
6 | 4,235 | 4,224 | |
MV | 3,985 | 3,974 | |
7 | Test Item dimethylamine-borane (20% in physiological saline) |
0,000 | -0,011 |
8 | 5,610 | 5,599 | |
9 | 6,490 | 6,479 | |
MV | 4,033 | 4,022 |
Table 4: In vitro Irritation Score (IVIS)
Cornea No. | Test Item | Corrected Opacity Value | Corrected OD490 Value |
IVIS |
1 | Negative Control Physiological Saline |
0.45 | 0.007 | 0.97 |
2 | 0.38 | 0.009 | ||
3 | 1.58 | 0.018 | ||
MV | 0.80 | 0.011 | ||
4 | Positive Control 20% Imidazol in physiological saline |
102.56 | 3.049 | 153.69 |
5 | 98.52 | 4.649 | ||
6 | 81.18 | 4.224 | ||
MV | 94.09 | 3.974 | ||
7 | Test Item dimethylamine-borane (20% in physiological saline) |
21.84 | -0.011 | 101.13 |
8 | 59.63 | 5.599 | ||
9 | 40.94 | 6.479 | ||
MV | 40.80 | 4.022 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In conclusion, based on the mean in vitro irritation score of 101.13 obtained in the bovine corneal opacity and permeability assay (OECD 437), the target substance is classified for irreversible effects on the eye (Category 1, H318).
- Executive summary:
The eye irritation potential of dimethylamine-borane (DMAB) (> 99% purity) was investigated in the bovine corneal opacity and permeability assay (OECD 437). The test item was suspended with physiological saline 0.9 % NaCl to gain a 20 % concentration. A mean in vitro irritation score (IVIS) of 101.13 was determined. The positive control induced the appropriate responses, indicating the validity of the assay. Based on the results, classification for irreversible effects on the eye (Category 1, H318) is warranted.
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.