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EC number: 425-380-9 | CAS number: 7397-46-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study, pre-test was only performed in in vitro skin models.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Available study from 1997
Test material
- Reference substance name:
- -
- EC Number:
- 425-380-9
- EC Name:
- -
- Cas Number:
- 7397-46-8
- Molecular formula:
- C5H13BO
- IUPAC Name:
- methyl diethylborinate
- Details on test material:
- - Name of test material (as cited in study report): DEMB
- Physical state: Water-white liquid
- Analytical purity: 99.4 %
- Lot/batch No.: 183
- Expiration date of the lot/batch: August 01, 1997
- Stability under test conditions: in the vehicle dry propylene glycol stable for 16-20 h
- Storage condition of test material: At room temperature in the dark
- Other: Density 0.76 g/ml
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: 7 weeks
- Weight at study initiation: Between 462-612 grams
- Housing: 5 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before the start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction:
A) Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.), 50:50 with water
B) The test substance at a 5% concentration
C) The test substance at a 5% concentration and Freunds' Complete Adjuvant separately very close together (0.05 ml each)
Percutaneous induction:
0.5 ml of a 20% test substance concentration
1. Challenge: 5 and 10 %
2. Challenge: 2 and 5 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction:
A) Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.), 50:50 with water
B) The test substance at a 5% concentration
C) The test substance at a 5% concentration and Freunds' Complete Adjuvant separately very close together (0.05 ml each)
Percutaneous induction:
0.5 ml of a 20% test substance concentration
1. Challenge: 5 and 10 %
2. Challenge: 2 and 5 %
- No. of animals per dose:
- control group: 5
experimental group 10 - Details on study design:
- RANGE FINDING TESTS: A preliminary study with non-living animal skin was performed
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three pairs of intradermal injections on day 1 and percutaneous induction with 20 % test substance on day 8
- Control group: treated with vehicle
- Site: scapular region
B. CHALLENGE EXPOSURE
- No. of exposures: 2 challenges
- Day(s) of challenge: day 22 and 29
- Site: first flank, second flank
- Concentrations: 1. challenge 5 and 10 %; 2. challenge 2 and 5 %
- Evaluation (hr after challenge): treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing.
Grading:
Grading challenge reactions:
0= No visible change
1= Discrete or patchy erythemae
2= Moderate and confluent erythemae
3= Moderete erythema and swelling
4= Intense erythemae and swelling - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st challenge, 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 1st challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 2.0. Total no. in groups: 9.0.
- Reading:
- other: 1st challenge, 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 1st challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 4.0. Total no. in groups: 9.0.
- Reading:
- other: 1st challenge, 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 6
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 1st challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 6.0. Total no. in groups: 9.0.
- Reading:
- other: 1st challenge, 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 5
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 1st challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 5.0. Total no. in groups: 9.0.
- Reading:
- other: 2nd challenge, 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 2nd challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 %. No with. + reactions: 2.0. Total no. in groups: 9.0.
- Reading:
- other: 2nd challenge, 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 2nd challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 %. No with. + reactions: 1.0. Total no. in groups: 9.0.
- Reading:
- other: 2nd challenge, 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 2nd challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 4.0. Total no. in groups: 9.0.
- Reading:
- other: 2nd challenge, 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 2nd challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
Applicant's summary and conclusion
- Executive summary:
According to Annex VI of the EU Regulation (EC) N0. 1272/2008 (CLP) and Annex I of the EU directive 67/548/EEC, DEMB is classified as sensitizing to the skin Cat 1 and R43, respectively.
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.
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