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EC number: 911-254-5 | CAS number: -
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 22 February 2010 and 11 March 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Meets the requirements of GLP. There are no deviations from the recommended guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 2-tert-butyl-4,6-dimethylphenol and 4-tert-butyl-2,5-dimethylphenol
- EC Number:
- 911-254-5
- Molecular formula:
- Not applicable - Multiconstituent substance
- IUPAC Name:
- Reaction mass of 2-tert-butyl-4,6-dimethylphenol and 4-tert-butyl-2,5-dimethylphenol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 12 or 13 weeks old
- Weight during the test: between 2.53 kg and 3.38 kg
- Housing: individual box installed in conventional air conditioned animal husbanding
- Diet (e.g. ad libitum): foodstuff (SDS - C15) was supplied freely
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system) was supplied freely
- Acclimation period: minimal 5-day acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
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 - Duration of treatment / exposure:
- Exposure: one instillation
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is obsetyed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional obsetvations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed. - Number of animals or in vitro replicates:
- 3 female animals
- Details on study design:
- SCORING SYSTEM: Eye examinations are carried out using the scale of lesion scores In the following order: chemosis, discharge, redness, iris, cornea (degree and extent of opacity).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
The ocular reactions observed during the study have been moderate and totally reversible:
- at the conjunctivae level: a moderate redness noted 1 hour after the test item instillation and totally reversible between days 10 and 11 associated with a moderate chemosis noted 24 hours after the test item instillation and totally reversible between days 8 and 10.
- at the iris level: a congestion, noted 24 hours after the test item instillation, and totally reversible between days 2 and 7.
- at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation, and totally reversible at day 7.
Furthermore, a corneal neovascularisation was noted at day1 in one animal, between day 1 and day 3 in a second animal and between day 2 and day 8 in the last one.
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye irritant (Cat 2) (CLP Regulation EC no. 1272/2008)
- Conclusions:
- In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item is irritating to eyes.
- Executive summary:
The test item was instilled as supplied, into the eye of threeNew Zealandrabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 and the test method B.5 of the council regulation n° 440/2008. The ocular reactions observed during the study have been moderate and totally reversible:
- at the conjunctivae level: a moderate redness noted 1 hour after the test item instillation and totally reversible between days 10 and 11 associated with a moderate chemosis noted 24 hours after the test item instillation and totally reversible between days 8 and 10.
- at the iris level: a congestion, noted 24 hours after the test item instillation, and totally reversible between days 2 and 7.
- at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation, and totally reversible at day 7.
Furthermore, a corneal neovascularisation was noted at day 1 in one animal, between day 1 and day 3 in a second animal and between day 2 and day 8 in the last one.
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item is irritating to eyes.
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