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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- other: test procedure in accordance with company standards
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
No reproducible, significant variation in local effects on skin and eye between members of the category have been reported but rather strong irritation or even corrosive effects. Therefore, the general hypothesis for the category approach that xylenol isomers exert qualitatively and quantitatively similar toxicity effects applies for the endpoint "skin irritation / corrosion".
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
Available data for two xylenol isomers and a mixture of isomers indicate a mostly strong reactivity with tissues of skin and eye. All 6 isomers as well as xylenol (mixed isomers) are classified as Skin Corr. 1B according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). 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:
- 1 - 10 applications of diluted or undiluted material to the intact or abraded skin of rabbits
- GLP compliance:
- no
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:
- not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- abraded
- Remarks:
- or intact skin
- Vehicle:
- other: Dipropylene glycol methyl ether (Dowanol DPM)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted, or 10% solution in Dowanol DPM
- Duration of treatment / exposure:
- 1 or repeated applications
- Observation period:
- 21 days
- Number of animals:
- not specified
- Details on study design:
- undiluted material: 1 application on intact and abraded belly skin, respectively
10% solution in Dowanol DPM: 10 applications on intact ear and belly skin; 3 applications on abraded belly skin
In addition patch tests with undiluted material and short exposure duration (0.5, 1, 5, and 10 min)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: hyperemia, edema, necrosis
- Remarks:
- based on clinical observation
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact and abraded skin
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- interpretation of non-guideline gradings
- Irritation parameter:
- edema score
- Remarks:
- intact and abraded skin
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- probability of moderate irritation
- Remarks:
- interpretation of non-guidline gradings
- Irritant / corrosive response data:
- See Table 1 and 2 below.
Any other information on results incl. tables
Table 1: Skin irritation study with exposure of rabbit skin to 3,5-xylenol
Material |
Condition |
Number of applications |
Site |
Response |
Undiluted |
Intact |
1 |
Belly |
Slight hyperemia and edema with moderate necrosis. Skin healed with moderate scear in 21 days. |
Undiluted |
Abraded |
1 |
Belly |
Slight hyperemia and edema with moderate necrosis. Skin healed with moderate scear in 21 days. |
10% solution in Dowanol DPM |
Intact |
10 |
Ear |
No irritation observed |
10% solution in Dowanol DPM |
Intact |
10 |
Bell |
Very slight hyperemia and slight to moderate exfoliation. Skin normal in 21 days. |
10% solution in Dowanol DPM |
Abraded |
3 |
Belly |
Slight exfoliation only. Skin essentially normal in 21 days. |
Table 2: Patch test with short exposure of rabbit skin to 3,5-xylenol
Material |
Exposure duration (min) |
Response |
Undiluted |
0.5 |
Essentially no irritation |
Undiluted |
1 |
Slight hyperemia |
Undiluted |
5 |
Slight hyperemia with moderate burn |
Undiluted |
10 |
Moderate hyperemia with moderate burn |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- 5 - 10 Minutes of skin contact may cause burns.
- Conclusions:
- 5 - 10 Minutes contact of the rabbit skin to 3,5-xylenol can cause burns and skin necrosis indicating a skin corrosion potential of the substance.
- Executive summary:
In a non-guideline in vivo skin irritation study a single application of undiluted 3,5-xylenol on intact or abraded belly skin of rabbits caused slight hyperemia and edema with moderate necrosis. The skin healed with moderate scear within 21 days. 10 Applications of a 10% solution in dipropylene glycol methyl ether (Dowanol DPM) did not induce irritation of the intact rabbit ear but evoked very slight hyperemia and slight to moderate exfoliation on intact belly skin. These effects were reversible within 21 days. Three applications of the diluted solution on abraded belly skin resulted in slight exfoliation only. The skin appeared to be essentially normal after 21 days. 5 - 10 Minutes contact of the rabbit skin to 3,5-xylenol can cause burns and skin necrosis indicating a skin corrosion potential of the substance.
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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