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EC number: 293-927-7 | CAS number: 91648-65-6
- 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://poisoncentres.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
- Study period:
- Jan/Feb 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study. No GLP compliance is claimed, however, the final report includes an audit and quality assurance inspections. The skin preparation was not exactly performed in accordance to OECD Guideline 404. Furthermore, a 48h observation was not performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The skin preparation was not exactly performed in accordance to OECD Guideline 404. The 48h observation was not performed.
- Principles of method if other than guideline:
- Detailed description of guideline deviations:
- Skin preparation: At 24 hours prior to study initiation, the fur on the back of each rabbit was clipped from an area approximately 240 cm2, and the skin was examined for abnormalities. On the day of treatment, four test sites (2.5 cm x 2.5 cm each), two on either side of the midline, were designated in the clipped area on the back of each rabbit. The test sites on the right side were abraded in a pattern with a hypodermic needle so as to penetrate the stratum corneum but not the dermis. The test sites on the left side were left intact. The results from the adraded test sites have been excluded from the calculation of the primary irritation index as the use of abraded skin does not follow current OECD test guidelines.
- Exposure: The application was for 24 h rather than the current OECD guideline exposure time of 4 h, and the 48h observation was not performed. Therefore, this represents a worst case. - GLP compliance:
- no
- Remarks:
- Auditation and quality assurance inspections of the final report were performed.
Test material
- Test material form:
- not specified
- Details on test material:
- - Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratories, Denver, PA
- Weight at study initiation: 2.0 to 2.7 kg
- Fasting period before study: No
- Housing: Individually housed in stainless steel cages (61.0 x 45.5 x 42.0 cm)
- Diet: Rabbits were fed Purina Lab Rabbit Chow HF (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: approx. 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20
- Humidity (%): approx. 40 (relative)
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES:
1982-01-26 - 1982-02-09
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL applied to each test site
- Concentration: neat material used - Duration of treatment / exposure:
- A 0.5 mL quantity of the test article was applied to each of the four test sites and covered with a 2.5 x 2.5 cm gauze pad which was secured by an adhesive dressing (CoverletR, Beiersdorf Inc., S. Norwalk. Conn.). The mid-section of the rabbit was wrapped in a lint-free cloth towel to prevent removal of the gauze pad while allowing the rabbit free movement. All wrapping materials and gauze pads were removed 24 hours after application and the test sites were washed with a 0.9 % sodium chloride solution to remove any residual test article.
- Observation period:
- The test sites were examined and scored 1, 3, 7 and 14 days after application for oedema, erythema, and eschar formation.
Each test site was scored for irritation according to the method of Draize. - Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 4 test sites (2.5 x 2.5 cm) on the back of each rabbit
- Type of wrap if used: Gauze pad was secured by an adhesive dressing (CoverletR, Beiersdorf Inc., S. Norwalk. Conn.). The mid-section of the rabbit was wrapped in a lint-free cloth towel to prevent removal of the gauze pad while allowing the rabbit free movement.
REMOVAL OF TEST SUBSTANCE
- Washing: 0.9 % sodium chloride solution
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 d
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 12/12 test sites scored 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 1.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 2/12 test sites scored 1; 10/12 test sites scored 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 14 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 14 d
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No details available.
- Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test report describes a valid guideline study, with auditation and quality assurance inspections of the final report. The test material is not considered to be a primary dermal irritant and does not require classification according to EU CLP.
- Executive summary:
A dermal irritation study was conducted using a similar procedure to that described in the current OECD Guideline 404 (Reckers, 1982). The test material (CAS No. 91648-65-6) was applied at a dose of 0.5 mL to the backs of 3 male and 3 female rabbits (strain: New Zealand White). The test article was left in contact with the skin for 24 hours and then the test sites were washed with 0.9 % sodium chloride and the rabbits observed during this time and for 14 days after its removal. The test sites were scored at 1, 3, 7 and 14 days after removal. Erythema was observed in all rabbits at 1 and 3 days following application. Mean scores of 2 (after 1 day) and 1.8 (after 3 days) were reported. After 7 days any effects were fully reversed. Edema did not occur. All rabbits appeared normal 14 days after application. No rabbits died during the study.
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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