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EC number: 217-533-1 | CAS number: 1879-09-0
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-tert-butyl-2,4-xylenol
- EC Number:
- 217-533-1
- EC Name:
- 6-tert-butyl-2,4-xylenol
- Cas Number:
- 1879-09-0
- Molecular formula:
- C12H18O
- IUPAC Name:
- 2-tert-butyl-4,6-dimethylphenol
- Test material form:
- not specified
- Details on test material:
- PHENOL,2-(1,1-DIMETHYLETHYL)-4,6-DIMETHYL
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not specified in the summary report.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- As per the guideline -0.5ml
- Duration of treatment / exposure:
- 4 hour
- Observation period:
- 72 hour
- Number of animals:
- Six animals (sex not specified).
- Details on study design:
- A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits.
An additional group of three rabbits was also treated.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 3.8
- Reversibility:
- not fully reversible within: 72 hours. Study terminated due to toxicity.
- Remarks on result:
- other: Study terminated due to toxicity.
- Irritant / corrosive response data:
- Surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted.
No corrosive effects were noted. - Other effects:
- A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits resulted in the death of one animal one day after treatment. It also became necessary to kill one animal for humane reasons later the same day owing to the development of severe respiratory problems. The surviving animal showed very slight to well-defined erythema and slight oedema at the treatment site during the study. The study was terminated after the 72-hour observation. At the time it was thought that the deaths may not have been treatment-related. An additional group of three rabbits was therefore treated. One rabbit in this group was also found dead two days after treatment. The two surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted. It was concluded that the deaths seen during this study were due to the toxicity of the test material. No further animals were treated.
Based on the results of the surviving animals the test material produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on these results the test material was classified as irritant according to EEC labelling regulations.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as abasicforclassificationand labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits resulted in the death of one animal one day after treatment. It also became necessary to kill one animal for humane reasons later the same day owing to the development of severe respiratory problems. The surviving animal showed very slight to well-defined erythema and slight oedema at the treatment site during the study. The study was terminated after the 72-hour observation. At the time it was thought that the deaths may not have been treatment-related. An additional group of three rabbits was therefore treated. One rabbit in this group was also found dead two days after treatment. The two surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted. It was concluded that the deaths seen during this study were due to the toxicity of the test material. No further animals were treated.
Based on the results of the surviving animals the test material produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The above results triggered classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). The following classification for irritant effects is therefore required:
Category 2 Skin Irritant
H315: Causes skin irritation
R 38- Irritating to skin
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