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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- to 1979-10-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1979-07-31 to 1979-10-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see box "principles of method if other than guideline"
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 402 "Acute dermal Toxicity"
- Deviations:
- yes
- Remarks:
- see box "principles of method if other than guideline"
- Principles of method if other than guideline:
- Deviations from OECD 404:
- Exposure: 24 h
- Application area: 100 cm²
- Occlusive
- Tested on the intact and abraded skin
Deviations from OECD 402:
- 4 Animals per dose group (abraded and intact skin 2 each)
- Application area: 100 cm²
- Occlusive - GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: dimethylamine-borane, Lot. No. 40-37 was received from Callery Chemical Company. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Rabbits of the New Zealand White variety weighing 2.5 kg or greater were obtained and acclimated to the laboratory a minimum of seven days. Rabbits were individually housed in suspended cages with feed and water freely available.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 126, 158, 200, 251, 316 and 398 mg/kg body weight
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 days
- Number of animals:
- 4 per dose group (2 abraded, 2 with intact skin)
- Details on study design:
- TREATMENT:
Prior to application of the test substance, one half (2) of the rabbits in each group received a series of abrasions with a sterile needle through the epidermis and two rabbits remained intact. The trunk of each rabbit was wrapped with an impervious material taped in place to form a reservoir over the test skin site. The test material was introduced onto the skin at the dose levels indicated below. During application, the rabbits were kept in a restrainer device and later were fitted with a collar to prevent ingesting the material and returned to their respective cage. Wrappings were removed after 24 hours and the test material was gently washed from the back.
OBSERVATIONS:
The rabbits were observed immediately after treatment, at four hours and daily for 14 days for signs of illness and mortality. Dermal reactions were scored daily for erythema and edema. Body weight was recorded at dosing and at 14 days for the survivors. Animals found dead or euthanized at 14 days were subjected to a macroscopic examination of the viscera. - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no significant signs of dermal irritation.
- Other effects:
- The LD50 was calculated to be 210 mg/kg body weight with 95% confidence limits of 156-284 mg/kg. No macroscopic changes were noted at necropsy, which could be attributed to the test material at the highest dose levels. All four rabbits showed uneven pitted appearance in the cortex of the kidney at the lowest level. No effects on body weight gain during the entire course of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study conducted in rabbits, no signs of dermal irritation were observed.
- Executive summary:
In an acute dermal toxicity study similar to OECD 402, dimethylamine-borane was applied occlusively to the abraded and intact skin of New Zealand White rabbits at concentrations of 126, 158, 200, 251, 316 and 398 mg/kg body weight for 24 hours. Afterwards, the test material was washed off. The animals were observed for 14 days for clinical signs and mortality including a daily scoring for erythema and edema. Body weight was recorded at dosing and at the end of the study for the survivors. Animals found dead or euthanised at 14 days were subjected to a macroscopic examination of the viscera. The LD50 was calculated to be 210 mg/kg body weight with 95% confidence limits of 156 - 284 mg/kg bw. No macroscopic changes were noted at necropsy, which could be attributed to the test material at the highest dose levels. All four rabbits showed uneven pitted appearance in the cortex of the kidney at the lowest level. All surviving animals gained body weight during the course of the study. There were no significant signs of dermal irritation noted throughout the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- see box "principles of method if other than guideline"
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 404 (Acute Dermal Irritation/ Corrosion)
- Deviations:
- yes
- Remarks:
- see box "principles of method if other than guideline"
- Principles of method if other than guideline:
- Deviations from OECD 404:
- Exposure: 24 h
- Application area: 100 cm^2
- Occlusive
- Tested on the intact and abraded skin
Deviations from OECD 402:
- 4 Animals per dose group (abraded and intact skin 2 each)
- Application area: 100 cm^2
- Occlusive - GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
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)
Constituent 1
- Specific details on test material used for the study:
- - Lot: 40-37
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Twenty-four albino rabbits of the New Zealand White variety weighing apprioxmately 2.5 kg or greater were obtained and acclimated to the laboratory for a minimum of seven (7) days. Rabbits were individually housed in suspended calges with feed and water freely available. The upper back area of all animals was clipped free of fur with an electric clipper.
Animal Care/Diet:
Animal husbandry will be conducted in accordance with the "Guide for Care and Use of Laboratory Animals," DHEW Publication 78-23.
Rabbits will receive Landmark Rabbit Feed on a daily basis. Tap water will be freely available. No contaminants are suspected that would interfere with the interpretation of study results.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- Prior to application of the test substance, one half of the rabbits received a series of abrasions, with a sterile needle, through the epidermis. The trunk of each rabbit was wrapped with an impervious material taped in place to form a reservoir over the test skin site. During application, the rabbits were kept in a restrainer device and later were fitted with a collar to prevent ingesting the material and returned to their respective cage.
- Duration of exposure:
- 24 h
- Doses:
- 126, 158, 200, 251, 316 and 398 mg/kg body weight
- No. of animals per sex per dose:
- 2 intact and 2 abraded rabbits per dose
- Control animals:
- no
- Details on study design:
- During application, the rabbits were kept in a restrainer device and later were fitted with a collar and returned to their respective cages. Wrappings were removed after 24 hours and the test material was gently washed from the back.
The rabbits were observed immediately after treatment, at four hours and daily for 14 days for signs of illness and mortality. Dermal reactions were scored daily for erythema and edema. Body weights were recorded at dosing and at 14 days for the survivors. Animals found dead or those euthanized were subjected to a macroscopic examination of the viscera.
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 210 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 156 - <= 284
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- 126 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The LD50 is calculated to be 210 mg/kg body weight with 95% confidence limits of 156-284 mg/kg. For detailed results see Table 1 in "Any other information on results incl. tables
- Gross pathology:
- No macroscopic changes were noted at necropsy which could be attributed to the test material at the highest dose levels. All four rabbits showed uneven pitted appearance in the cortex of the kidney at the lowest level.
- Other findings:
- No significant dermal reactions were observed.
Any other information on results incl. tables
Table 1: Mortality
mg/kg | No. Dead/No. Dosed |
398 | 4/4 |
316 | 3/4 |
251 | 2/4 |
200 | 3/4 |
158 | 2/4 |
126 | 0/4 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- In this acute dermal toxicity study, the dermal LD50 value in rabbits after treatment with dimethylamine-borane was 210 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study similiar to OECD 402, groups of 4 New Zealand White rabbits (2 with intact, 2 with abraded skin) were dermally exposed to dimethylamine-borane for 24 hours at doses of 389, 316, 251, 200, 158 and 126 mg/kg body weight. Animals then were observed for 14 days. The dermal LD50 was determined to be 210 mg/kg bw. There were no treatment related clinical signs and necropsy findings. All surviving rabbits gained weight during the course of the study.
Based on this study, dimethylamine-borane is of slight toxicity. Based on the dermal LD50 of 210 mg/kg bw, the test item does warrant for classification as Acute Tox Cat. 3 according to CLP Criteria.
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