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Diss Factsheets
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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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: in vitro GLP-study which was performed as a dose-finding screening study for the guinea pig maximization test
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Principles of method if other than guideline:
- Assessment of physico-chemical and bioiogical reactions of different concentrations of DEMB when placed on non-living animal-skin.
The clipped, dorsal skin of three sacrificed female rats was removed, stretched and fixed on a flat, metal surface. Single samples of approximately 0.5 ml of a
10 mg/ml, a 200 mg/ml solution and the undiluted test substance were each placed on a different stretched, clipped skin (open application).
A sacrificed guinea pig was in situ treated as follows: intradermal injections were given in the clipped scapular region of the undiluted test substance and a 200 mg/ml and 10 mg/ml solution, mimicking the procedures of a sensitisation study. Moreover, the undiluted test substance and the 200 mg/ml solution were each occlusively, applied to a clipped flank. Two hours after application the dressing was removed. - GLP compliance:
- yes
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
Test animals
- Species:
- other: skin in vitro model
- Strain:
- other: Wistar rats strain Crl:(WI) BR; guinea pig: Himalayan strain
- Details on test animals or test system and environmental conditions:
- a skin in vitro model was used
Test system
- Type of coverage:
- other: open and occlusive
- Preparation of test site:
- other: not applicable
- Vehicle:
- other: Propylene glycol
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 10, 200 mg/ml and undiluted test substance - Duration of treatment / exposure:
- rat-skin: 1, 5, 10, 30 min
guinea pig: 15 min and 2 hours - Observation period:
- Rat-skin: The physico-chemical and biological reactions were continuously monitored during the exposure period. Findings were recorded approximately 1, 5, 10 and 30 minutes after application.
Guinea pig: The reactions in the dermal tissue were assessed and recorded 15 minutes (intradermal injection sites only) and 2 hours after treatment. - Number of animals:
- rats: 3
guinea pig: 1 - Details on study design:
- Three female rats were sacrificed using a oxygen/carbon dioxide asphyxiation procedure. The dorsal fur was clipped using an electric clipper. The dorsal fur was removed, stretched and fixed on a flat, metal surface using sticking tape. The skin to be treated was intact and free from any abnormality. Single samples of approximately 0.5 ml of a 10 mg/ml, a 200 mg/ml solution and the undiluted test substance were each placed on a different stretched, clipped skin (open application).
At a later stage, a guinea pig was sacrificed in an identical manner. Subsequently, intradermal injections were given in the clipped scapular region of the undiluted test substance and a 200 mg/ml and 10 mg/ml solution (0.1 ml/injection in duplicate), mimicking the procedures of the sensitisation study. One of each pair of injections was on each side of the midline and from cranial (10 mg/ml) to caudal (undiluted). Moreover, the undiluted test substance and the 200 mg/ml solution (0.5 ml each) were each occlusively, applied to a clipped flank using Scotchpak-non-woven patches (2x3 cm) on Micropore tape and held in place by Coban elastic bandage. Two hours after application the dressing was removed.
Results and discussion
In vitro
Results
- Remarks on result:
- other: see "Any other information on results incl. tables"
Any other information on results incl. tables
Administration of undiluted DEMB or any of the dilutions (ie. 200 and/or 10 mg/ml in propylene glycol) on freshly prepared non-living animal skin via open or occlusive application, did not result in any physico-chemical reaction. After open application, no biological reactions in the rat-skin were observed in response to the three concentration used.
Occlusive administration of the undiluted test substance for 2 hours to a sacrificed, intact guinea pig, caused corrosion of the skin as observed after removal of the bandages. The skin-site treated with a 200 mg/ml solution caused no visible changes as assessed in situ. After excision of the treated skin, slight effects, a yellowish discolouration of the subcutis, were observed to a 200 mg/mL solution. The intradermal injections of different concentrations made in the guinea pig showed a dose response relation ship present as a gradual increase of the diameter of necrosis with increasing concentrations.
Applicant's summary and conclusion
- Conclusions:
- Rat: non-corrosive
Guinea pig: corrosive - Executive summary:
When administered under occlusive conditions the undiluted test substance should be regarded as corrosive to the skin. The absence of any significant biological effect after occluded administration of a 200 mg/ml concentration indicate that this (and lower) concentration is acceptable and well tolerated in vivo. The results of the intradermal injections indicate that concentrations lower than 10% may be acceptable for use in vivo, ie. a skin sensitization guinea pig maximization test. In view of the selection criteria for suitable concentrations to be used in a skin sensitization study, a maximum concentration of 5% is suggested for intradermal injection and a 20% for epidermal application.
According to Annex VI of EU Regulation (EC) N0. 1272/2008 (CLP) and Annex I of EU directive 67/548/EEC, DEMB is classified as corrosive Cat 1b and R34, 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.
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