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Diss Factsheets
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EC number: 201-816-1 | CAS number: 88-27-7
- 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: Test procedure in accordance with generally accepted scientific standards. Similar to OECD guideline 405. Non-GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize JH et al. J. Exp. Pharmacol. Ther., 83, 377-390, 1944. Draize JH Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 36-45, Ass. of Food and Drug Officials of the United States, Topeka, Kansas, 1965
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,6-di-tert-butyl-α-dimethylamino-p-cresol
- EC Number:
- 201-816-1
- EC Name:
- 2,6-di-tert-butyl-α-dimethylamino-p-cresol
- Cas Number:
- 88-27-7
- Molecular formula:
- C17H29NO
- IUPAC Name:
- 2,6-di-tert-butyl-4-[(dimethylamino)methyl]phenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Anti-oxidant 703 (AN-703)
- Substance type: Yellow, crystalline solid
- Physical state: solid
No additional details reported in the report.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data reported
- Age at study initiation: no data reported
- Weight at study initiation: no data reported
- Housing: no data reported
- Diet (e.g. ad libitum): no data reported
- Water (e.g. ad libitum): no data reported
ENVIRONMENTAL CONDITIONS: no data reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of finely powdered AN-703 instilled onto one eye. - Observation period (in vivo):
- Observation were made at 24, 48, 72 and 168 hours after application
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No removal of the test substance
SCORING SYSTEM: Draize score system used to report result in the report. Raw data of the observations were available in the report, therefore, EU scoring has been reported in the results section for Cornea - Opacity, Iris - Inflammation, Conjunctivae - Redness and Chemosis.
TOOL USED TO ASSESS SCORE: Not reported in the report.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- (after 168 hours - score: 1)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Conjunctiva Chemosis score:
* Animal 1 - 24, 48 and 72 hours - 1.66 max: - 2 - fully reversible within: 168 hours
* Animal 2 - 24, 48 and 72 hours - 0
* Animal 3 - 24, 48 and 72 hours - 1 max: 2 - fully reversible within: 72 hours
* Animal 4 - 24, 48 and 72 hours - 1 max: 2 - fully reversible within: 72 hours
* Animal 5 - 24, 48 and 72 hours - 2 max: 3 - fully reversible within: 168 hours
* Animal 6 - 24, 48 and 72 hours - 0
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According the study performed the test item is considered as irritant to New Zealand white Rabbits with full reversibility after 168 hours. The test item needs to be classified as eye irritation- category 2 according to the criteria defined in the ECHA guidance on the application of CLP criteria, 2009 (249-250) CLP regulation N°1272/2008. This is based on a score of 1 or greater for cornea opacity in 4 or more of 6 animals. According to the criteria of Directive 67/548/EEC and amendments the test item is not classified as irritant to eyes.
- Executive summary:
0.1 ml of the test item was applied into the conjunctival sac of one eye in each of 6 New Zealand white rabbits. The eye reactions were scored after 24, 48, 72 and 168 h. All effects were fully reversible within the observation period with the exeption of corneal opacity in one animal that however showed signs of reversibility. Mild irritation effects were observed at grades that are borderline for classification. According to the ECHA guidance on application of CLP criteria, 2009 a classification as category 2 eye irritant (H319) is proposed based on the fact that 4 of 6 rabbits had cornea scores at or above 1 for the 24, 48, 72 h average. Based on Dir. 67/548/EEC however, no classification as eye irritant (R36) would be attributed.
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