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Diss Factsheets
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EC number: 268-211-2 | CAS number: 68037-36-5
- 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:
- 22 March 2017 to 12 April 2017
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Quality Assurance Statement
- Test type:
- standard acute method
Test material
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- One group of 5 male and 5 female rats. Upon arrival, all animals were housed individually in clean, wire-mesh cages. The animals were maintained by the animal husbandry staff of Charles River in accordance with SOPs. Animals were maintained in accordance with the Guide for the Care and Use of Laboratory Animals.2 The animal facilities at Charles River Ashland are accredited by AAALAC International. Enrichment devices were provided to all animals as appropriate throughout the study for environmental enrichment and to aid in maintaining the animals’ oral health, and were sanitized weekly.
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: [yes] 5
- Males: 5
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 200 to 350 g (males)/150 to 300 g (females)
- Fasting period before study: No
- Housing: All animals will be individually housed following receipt in clean, wire-mesh cages in an environmentally controlled room. The cages will be cleaned and changed routinely at a frequency consistent with maintaining good animal health.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C to 26°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): a minimum of 10 room air changes per hour, 100% fresh air.
- Photoperiod (hrs dark / hrs light): 12-hour light/dark photoperiod
IN-LIFE DATES: From: To: 23 March 2017 to 12 April 2017
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: backs and flanks
- % coverage: 10%
- Type of wrap if used: 4-ply gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): bandages were removed and the sites were wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): 50 mg/kg
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Lot/batch no. (if required): 1941172044
- Purity: 100% - Duration of exposure:
- 24 hours
- Doses:
- 1
- No. of animals per sex per dose:
- 5 animals per sex per dose (male and female)
- Control animals:
- not specified
- Details on study design:
- Duration of observation period following administration: 14 days (the observation period may be extended if signs of systemic toxicity are present)
- Frequency of observations and weighing: Study Days 0, 7, and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs/observations, dermal observations, body weight, other: A gross necropsy examination on major organ systems of the cranial, thoracic and abdominal cavities will be conducted on all animals found dead, euthanized in extremis or euthanized at termination.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality.
- Clinical signs:
- other: No significant clinical observations.
- Gross pathology:
- At the scheduled necropsy, macroscopic findings consisted of blue discolouration of the tail for 4 males and all females. Blue discolouration was observed at the application site for 1 female. The discolouration findings were expected based on the colour of test material and were not considered adverse.
Any other information on results incl. tables
See tables attached in the background section below for final report findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the LD50 of the test material was greater than 2000 mg/kg when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats.
- Executive summary:
Based on the results of this study using OECD 402, the LD50 of the test material was greater than 2000 mg/kg when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats.
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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