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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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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
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- 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:
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See "Principles of Method if other than guideline"
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See "Principles of Method if other than guideline"
- Principles of method if other than guideline:
- A single instillation of the test material to the non-irrigated eye of one rabbit produced areas of diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Other adverse ocular effects noted were a dulling of the normal lustre of the corneal surface and petechial haemorrhage of the nictitating membrane. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. The animal was therefore killed for humane reasons in accordance with current U.K. Home Office guidelines and no further animals were treated.
- 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:
- other: liquid
- Details on test material:
- PHENOL,2-(1,2-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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Not specified in the report.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Not specified
- Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- Two days
- Number of animals or in vitro replicates:
- One animal (sex not specified)
- Details on study design:
- A single instillation of the test material to the non-irrigated eye of one rabbit.
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 39
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Areas of diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation.
- Other effects:
- Other adverse ocular effects noted were a dulling of the normal lustre of the corneal surface and petechial haemorrhage of the nictitating membrane. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. The animal was therefore killed for humane reasons in accordance with current U.K. Home Office guidelines and no further animals were treated.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- It is considered reasonable to assume that the test material is irritant according to EEC labelling regulations.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).
A single instillation of the test material to the non-irrigated eye of one rabbit produced areas of diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Other adverse ocular effects noted were a dulling of the normal lustre of the corneal surface and petechial haemorrhage of the nictitating membrane. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. The animal was therefore killed for humane reasons in accordance with current U.K. Home Office guideline and no further animals were treated.
The test material produced a maximum total score of 39.0 and was considered to be at least a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only).
It is considered reasonable to assume that the test material is irritant according to EEC labelling regulations. As such, the 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 Eye Irritant
H319: Causes serious eye irritation
R 36- Irritating to the eyes
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