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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Study initiated: 2/23/81. Study terminated: 3/02/81
- 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)
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 "eye irritation".
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 with hazard statement H314 (Causes severe skin burns and eye damage) 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:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Range-finding eye irritation test in two rabbits (Draize test) with rating of irritation effects according to a classification system outlined in Dow Chemical Protocol 78P-103.
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male animals
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml (undiluted)
- Duration of treatment / exposure:
- 7 days (eyes were not washed)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- 0.1 ml of the test substance, as received, was introduced into the conjunctival sac. Eyes were not washed. Rating for irritation effects on cornea, iris and conjunctivae was performed 4, 24, 48, 72, and 96 hours, as well as 7 days after instillation of the test material according to a classification system outlined in Dow Chemical Protocol 78P-103.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2.5
- Reversibility:
- fully reversible
- Remarks:
- max score after 4 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 14
- Reversibility:
- fully reversible within: 96 h
- Remarks:
- max score after 4 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Time |
Structure |
Score |
||
Rabbit 1 |
Rabbit 2 |
Mean |
||
4 h |
Cornea Iris Conjunctivae |
0 0 4 |
0 2.5 14 |
0 1.3 9 |
24 h |
Cornea Iris Conjunctivae |
0 0 4 |
0 0 4 |
0 0 4 |
48 h |
Cornea Iris Conjunctivae |
0 0 0 |
0 0 2 |
0 0 1 |
72 h |
Cornea Iris Conjunctivae |
0 0 0 |
0 0 2 |
0 0 1 |
96 h |
Cornea Iris Conjunctivae |
0 0 0 |
0 0 0 |
0 0 0 |
7 d |
Cornea Iris Conjunctivae |
0 0 0 |
0 0 0 |
0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the duration of the ocular effects only, the mixture of xylenol isomers was considered by the authors as "moderately" irritating to the eyes of rabbits (i.e., all ocular effects were reversible within 7 days, but not within 24 hr after dosing).
- Executive summary:
The effect of a mixture of xylenol isomers on the eye was investigated in New Zealand White rabbits (SS_in vivo_Range finder study on eye irritation_rabbit_1982_Target). 0.1 ml of the mixture of xylenol isomers, as received, was introduced into the conjunctival sac. Eyes were not washed. Rating for irritation effects on cornea, iris and conjunctivae was performed 4, 24, 48, 72, and 96 hours, as well as 7 days after instillation of the test material according to a classification system outlined in Dow Chemical Protocol 78P-103. Irritation of iris and conjunctivae but no corneal opacity was observed. Rating of conjunctival effects 4 hours after installation of the test substance resulted in a score of 14 and 4, respectively. After 24 hours, a conjunctival score level of 4 was noted in both animals. All effects were fully reversible within 92 hours. Range-finding irritation data indicate this substance is "moderately" irritating to the eyes of rabbits.
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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