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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Some experimental details are not reported.
- 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 are characterised by similar toxicity effects and a closely related toxicokinetic behaviour applies for the endpoint "dermal absorption".
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:
- 1 961
- Report date:
- 1961
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 2000 mg of the solid material per kg body weight along with 5 ml water were applied to the rabbit skin under a semi- occlusive coverage (cuff) for a 24-hour period.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,5-xylenol
- EC Number:
- 203-606-5
- EC Name:
- 3,5-xylenol
- Cas Number:
- 108-68-9
- Molecular formula:
- C8H10O
- IUPAC Name:
- 3,5-dimethylphenol
- Test material form:
- solid
- Details on test material:
- A sample from the raw material used in the Zectran process- State of aggregation:
- Crystal structure: Needle-like
- Colour. white
- Density:
- Melting point 68 °C
- Boiling point: 219.5°C @ 760 mmHg
- Molecular weight: 122.16
- Molecular formula: C8H10O
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- 5 mL of water was applied under the cuff along with the weighed amount of solid material
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per group:
- 2
- Control animals:
- no
- Details on study design:
- 2000 mg of the solid material per kg body weight along with 5 ml water were applied to the rabbit skin under a semi- occlusive coverage (cuff) for a 24-hour period.
Results and discussion
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- yes
Percutaneous absorption
- Key result
- Time point:
- 24 h
- Dose:
- 2000 mg/kg bw
- Remarks on result:
- other: no indication of absorption in acutely toxic amounts
Any other information on results incl. tables
Response remarks:
Moderate necrosis, edema and hyperemia with hard, black scab formation.
Applicant's summary and conclusion
- Conclusions:
- When the skin of rabbits was exposed to a dose level of 2000 mg 3,5-xylenol per kg body weight for 24 hours, there was no indication of absorption through the skin in acutely toxic amounts.
- Executive summary:
A skin absoprtion study using the Cuff Technique was conducted according to generally acccepted scientific methods with sufficient documentation. In this test 2000 mg of 3,5-xylenol per kg body weight along with 5 ml water were applied to the skin of two rabbits under a semi-occlusive coverage (cuff) for a 24-hour period. None of the exposed rabbits died, concusively there was no indication of absorption through the skin in acutely toxic amounts.
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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