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EC number: 237-235-5 | CAS number: 13703-82-7
- 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:
- 2016-09-20 - 2016-10-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate issued by "The Department of Health of the Government of the United Kindom" (2016-10-28).
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Magnesium metaborate
- EC Number:
- 237-235-5
- EC Name:
- Magnesium metaborate
- Cas Number:
- 13703-82-7
- Molecular formula:
- BHO2.1/2Mg
- IUPAC Name:
- magnesium metaborate
- Test material form:
- liquid
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMs (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200g, the weight variation did not exceed ± 20% of the mean weight for each sex.
- Housing: The animals were housed idividually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 -70%
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shorn skin on back and flanks of each animal
- % coverage: approximately 10% of total body surface area
- Type of wrap if used: self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Dose level: 2000 mg/kg
- Dose volume: 1.8 mL/kg
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations 30 minutes, 1, 2 and 4 hours after exposure. On the subsequent days once daily. Weighing of the individuals occured on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: skin reactions observed daily, body weight (day 0, 7 and 14), toxicological effects, behavioural and clinical abnormalities. - Statistics:
- Not reported. Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test item was made.
Results and discussion
- Preliminary study:
- Not performed. Use of available information on the toxicity of the test item to determine the dose.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- Very slight erythema (barely perceptible) was observed at the test sites of all animals 1 day after dosing and persisted in one male and two females 2 days after dosing.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS (CLP) criteria not met
- Conclusions:
- No mortality occurred at a maximum tested level of 2000 mg/kg bw and the study has been completed as a limit test. The LD50 is considered to be more than 2000 mg/kg.
- Executive summary:
An acute dermal toxicity study was conducted according to OECD Guideline 402 and in compliance with GLP criteria. The initial weight of each of 5 Wistar strain rats per sex was at least 200 g. Approximately 24 hours prior to the application of the test material, the hair of each animal was closely clipped on the back and the flanks. A single dose of 2 g/kg of the test material was administered dermally to five male and female animals. The test material was kept in contact with the skin for a period of 24 consecutive hours under a self-adhesive bandage. The application site and surrounding areas were wiped clean of residual test material at the end of the 24-hour exposure period with cotton wool moistened with distilled water. The animals were observed for abnormal clinical and behavioral signs frequently on the day of dosing and once daily for 14 days after treatment. Individual body weights were recorded on the day of dosing and on days 7 and 14. No rats were used as a control group. The observation period was 14 days and ended with the euthanization of the rats on day 14. Body weight was recorded on day 0, day 7 and on day 14: animals showed expected gain in body weight over the study period, except for two females which showed body weight loss or no gain in body weight during the first week but expected gain of body weight during the second week. Each animal was subject to gross necropsy which consisted of an external examination and opening of the abdominal and thoracic cavities. Very slight erythema (barely perceptible) was observed at the test sites of all animals 1 day after dosing and persisted in one male and two females 2 days after dosing. There were no deaths during the study period and no signs of systemic toxicity were noted during the observation period. An acute dermal median LD50of the test item in the female Wistar strain rat was found to be greater than 2000 mg/kg body weight.
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