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Diss Factsheets
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EC number: 605-293-4 | CAS number: 162568-25-4
- 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)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certified by BAM according to DIN EN 45001.
Test material
- Test material form:
- other: The test material contained 50% WS400517 in organic solvent
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Number: 3 animals,
- Average bodyweight: 3.0 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: The test material contained 50% WS400517 in organic solvent and was used after warming to 40°C
- Controls:
- not required
- Amount / concentration applied:
- 500 mg test material (i.e. formulation containing 50.3% WS400517) per approx. 6 cm2 skin (2.5 cm x 2.5 cm) per animal.
The test material was warmed to 40°C for administration. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days post patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE PREPARATION
Samples of 500 mg of the warmed test substance were applied to the shaved skin of albino rabbits and covered with gauze squares of the size 2.5 cm x 2.5 cm on the skin. Patches were fixed with adhesive plaster. Untreated shaved skin served as controls.
TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE
Semi-occlusive treatment lasted 4 hours. Then the dressings were removed and residual test substance was dabbed off the skin with a wet towel.
Time points of skin evaluation:
The treated skin patches were evaluated at 1 hour post patch removal and at 24, 48 and 72 h and 7 days post patch removal. Only differences from controls were considered to be positive reactions. The scoring system for the grading of skin reactions is listed in Table 1 (next field below).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h (erythema grade 1 was seen in 3 animals at 1 hour post patch removal)
- Irritation parameter:
- edema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h (edema grade 1 was seen in 1 animal at 1 hour post patch removal)
- Irritant / corrosive response data:
- At 1 hour post patch removal, erythema grade 1 (slight in degree and scarcely visible) was recorded in each animal and was associated with an edema grade 1 (very slight in degree and scarcely visible) in one of them. By 24 hours post patch removal and during the remainder of the 7-day observation period signs of irritation were no longer evident.
- Other effects:
- Mortality or behavioural changes indicative of an adverse effect were not evident. Weighing of the animals at 7 days post treatment revealed normal body weight gain.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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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