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Diss Factsheets
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EC number: 202-461-5 | CAS number: 95-87-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Available data show that there is no significant variation in acute dermal toxicity between members of the category. Therefore, the general hypothesis for the category approach that xylenol isomers exert qualitatively and quantitatively similar toxicity effects applies for the endpoint "acute dermal toxicity".
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
The acute dermal toxicity of 4 individual xylenol isomers was found to be low, with similar rat or rabbit LD50 values in the range from 1000 to 2400 mg/kg bw. See attached read-across justification for further information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Treatment of closely clipped rabbit skin under occlusive coverage for a 24-hour period
- GLP compliance:
- no
- Test type:
- other: range-finding test in 2 animals
- Limit test:
- yes
Test material
- Reference substance name:
- 2,5-xylenol
- EC Number:
- 202-461-5
- EC Name:
- 2,5-xylenol
- Cas Number:
- 95-87-4
- Molecular formula:
- C8H10O
- IUPAC Name:
- 2,5-dimethylphenol
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test substance as received, was held under an impervious cuff in continuous 24-hour contact with the closely clipped skin. After the 24-hr exposure, the treated skin was washed with lukewarm water.
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- not specified
- Details on study design:
- Clinical observation for a post-dosing period of 14 days, with consecutive gross pathological examination
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No
- Clinical signs:
- other: Skin irritation with severe erythema, severe edema, followed by desiccation, eschar formation and peeling of eschar was noted. After washing the exposed area, the rabbits were observed preening the exposure areas.
- Gross pathology:
- No gross changes were observed in either rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS (CLP) criteria not met
- Conclusions:
- The mixture of xylenol isomers used was considered to be "practically non-toxic" by a single skin application because the rabbit dermal LD50 was estimated to be greater than 5000 mg/kg bw. The skin reactions observed during this study indicate this substance is "severely" irritating to rabbit skin.
- Executive summary:
In a non-guideline range finding study, two New Zealand White rabbits were dermally exposed to a limit dose of 5000 mg of a xylenol isomer mixture per kg body weight. The closely clipped skin was treated under occlusive coverage for a 24 -hour period with consecutive washing of the exposed skin area. Local skin irritation with severe erythema, severe edema, followed by desiccation, eschar formation and peeling of eschar was noted but no signs of systemic toxicity. Pathological examination after the 14-day observation period did not reveal gross changes. A dermal LD50 value > 5000 mg/kg was derived from this range-finding study.
This result can be transferred to the target test item 2,5-xylenol based on high structural similarities in the read-across category of xylenol isomers (see 'Read-across statement' in section 13.2).
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