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Diss Factsheets
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EC number: 935-814-3 | CAS number: 1797437-47-8
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guidelines No. 402 “Acute Dermal Toxicity” and in accordance with GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Guideline followed.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report)
- Physical state: White powder
- Analytical purity: 99.5%
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Age at study initiation: 8-12 weeks (All the females were nulliparous and non-pregnant)
- Weight at study initiation: Atleast 200g
- Fasting period before study: overnight fasting immediately before dosing.
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 Deg C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back and Flanks
- % coverage: 10% (approximately)
- Type of wrap if used: A piece of surgical guaze was placed over thetreatment area and semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with cotton wool moistened with arachis oil.
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): Test item was moistened with arachis oil. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bodyweight.
- No. of animals per sex per dose:
- 5 male and 5 female rats were exposed to 2000 mg/kg bodyweight.
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for death or overt signs of toxicity 30 min, 1, 2 and 4 hour after dosing and subsequently once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None
Results and discussion
- Preliminary study:
- No mortality or evident toxicity observed at a dose level of 2000 mg/kg bodyweight.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality related to test item dermal toxicity.
However one animal was killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK HomeOffice Project Licence.
Clinical Observations: Signs of systemic toxicity confined to the animal that was humanely killed were prostration, ptosis and increased respiratory rate.
Necropsy: Abnormalities noted at necropsy of the animal that was humanely killed were haemorrhagic lungs, dark liver, dark spleen, small testes, enlarged prostate and fluid filled and reddened bladder. - Clinical signs:
- other: There were no signs of systemic toxicity noted in the surviving animals. Signs of systemic toxicity confined to the animal that was humanely killed were prostration, ptosis and increased respiratory rate.
- Gross pathology:
- No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Abnormalities noted at necropsy of the animal that was humanely killed were haemorrhagic lungs, dark liver, dark spleen, small testes, enlarged prostate and fluid filled and reddened bladder. - Other findings:
- Dermal Irritation: Very slight erythema was noted at the test sites of three females. No ther signs of dermal irritation were noted.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat following OECD TG No. 402 A group of 10 animals (5 males and 5 females) was given a single, 24 h, semi-occluded dermal application of the test item to intact skin at a dose level of 2000mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy at the end of study period.
Mortality: One animal was killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence.
Clinical Observations: Signs of systemic toxicity confined to the animal that was humanely killed were prostration, ptosis and increased respiratory rate. There were no signs of systemic toxicity noted in the surviving animals.
Dermal Irritation: Very slight erythema was noted at the test sites of three females. No signs of dermal irritation were noted. Bodyweight: Surviving animals showed expected gains in bodyweight over the study period.
Necropsy: Abnormalities noted at necropsy of the animal that was humanely killed were haemorrhagic lungs, dark liver, dark spleen, small testes, enlarged prostate and fluid filled and reddened bladder. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
CONCLUSION: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bodyweight.
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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