Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-089-3 | CAS number: 1300-71-6
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study in compliance with specific test guidelines, well documented, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CFR/USA, Title 16, Section 1500.42
- 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
- Details on test material:
- - Name of test material (as cited in study report): Produkt-Nr. 111.184 (= 3,5-dimethyl phenol)
- Molecular formula (if other than submission substance): C8H10O
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: solid
- Analytical purity: specified as "pure"
- Impurities (identity and concentrations): no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: J. Scheele, Werl/Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: mesh metal cage
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Air-conditioned room
- Temperature (°C): 22 +-1 °C
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg
TEST MATERIAL
- Amount(s) applied: 100 mg
TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 24 h, 48 h, 72 h and 7 d after instillation
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize numerical scores (recommendation of the Food and Drug Officials of USA 1959)
- Cornea: opacity (A), area affected (B) => basis of calculation A x B x 5 (Draize Score 1)
- Iris: irritation effect, response to light (A) => basis of calculation A x 5 (Draize Score 2)
- Conjunctivae: erythema (A), oedema/chemosis (B), discharge (C): => basis of calculation (A + B + C) x 2 (Draize Score 3)
- EVALUATION: Reading after 24, 48, and 72 h and
calculation of an "Irritation Score" = Sum of "Draize Scores" at the three time points for each animal
divided by 18 ( 3 time points, 6 animals).
The ranking system of the "Irritation Score" was as follows
(based on ETAD recommendation):
0 - 10 not irritating
11 - 25 slightly irritating
26 - 56 moderately irritating
57 - 110 severely irritating
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein (not specified)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 24, 48, and 72 h
- Score:
- 58.4
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- Cornea with diffuse and partly opalescent areas (6/6 animals);
iris with reduced response to light, increased injection of blood vessels (2/6 animals);
conjunctivae and eyelids swollen, erythematous, nictitating membrane covered with blebs, increased discharge (6/6 animals).
No significant reversibility of effects during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: code of Federal Regulations, Title 16 Section 1500.42
- Conclusions:
- The average irritation index was 58.4 and the substanvce was evaluated as severely irritating in accordance with the recommednations of ETAD.
- Executive summary:
The eye irritancy of 3,5 xylenol was studies in 6 New Zealand white rabbits using the method of the US consumer product safety commission (code of Federal Regulations, Title 16 Section 1500.42). The animals were given a single instillation of 100mg into the conjunctival sac of one eye and the effects were assessed at 24, 48 and 72 hrs after instillation. The effects were evaluated using the Draize scoring system in accordance with the recommendations of ETAD. In all rabbits, irritation of the conjunctivae with reddening, chemosis and ocular dishcarge were present at all time points as was corneal clouding, the effects being only slightly reversible during the 3 -day observation period. The iris showed injected vessels. The average irritation index was 58.4 and the substanvce was evaluated as severely irritating in accordance with the recommednations of ETAD.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)