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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 310-154-3 | CAS number: 121158-58-5
- 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:
- weight of evidence
- Study period:
- 12th March to 9th April 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Similar to OECD guideline and conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol, dodecyl-, branched
- EC Number:
- 310-154-3
- EC Name:
- Phenol, dodecyl-, branched
- Cas Number:
- 121158-58-5
- Molecular formula:
- Not appropriate. UVCB substance
- IUPAC Name:
- 4-(3,4,5,6-tetramethyloctan-2-yl)phenol
- Details on test material:
- The test material used in this study was an amber viscous liquid, coded B8959-20-1. Composition data is held by the sponsor. It was received from the sponsor on February 21, 1990 and stored at ambient temperature. In the opinion of the sponsor, the test material is stable under the recommended storage conditions.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: R and R Rabbitry, Stanwood, Washington, U.S.A
- Age at study initiation: The animals were 12-20 weeks old when dosed.
- Housing: The animals were housed individually in stainless steel support bar-bottom cages in an air-conditioned room.
- Diet (e.g. ad libitum): The animals were fed a daily ration of Purina Certified High Fiber Rabbit Chow #5325
- Water (e.g. ad libitum): Free access to water
- Acclimation period: Conditioning period of 4-10 weeks and examined for ocular defects before dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 46 - 66%
- Photoperiod (hrs dark / hrs light): The photoperiod was a 12-hour light/dark cycle.
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:
- 30 seconds
- Observation period (in vivo):
- 1, 24, 48 & 72 hours after treatment and at days 7 & 14.
- Number of animals or in vitro replicates:
- 6 animals for unwashed eyes and 3 animals for washed eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After a 30-second exposure, both eyes of three of the rabbits were additionally rinsed with distilled water for one minute at a rate of approximately 250 milliliters per minute.
SCORING SYSTEM:
Irritation was graded using the method of Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: no effects seen
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: no effects seen
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- In treated-unrinsed eyes, no corneal opacity or iritis was observed. Conjunctival redness, chemosis and discharge were observed at one through 24 hours. Conjunctival discharge cleared by 24 hours in treated-rinsed eyes. The mean 24-hour Draize score for treated-unrinsed eyes was 5.0/110. Conjunctival redness continued to Day 4 in rinsed eyes and Day 7 in unrinsed eyes. All eyes were clear by Day 10. Alopecia and flaky skin were observed around the eye to Day 14. Lackluster cornea, white material in the conjunctival sac, and a thickening of the conjunctival sac were also observed. Rinsing did not significantly affect the severity or persistence of irritation.
Any other information on results incl. tables
In treated-unrinsed eyes, no corneal opacity or iritis was observed. Conjunctival redness, chemosis and discharge were observed at one through 24 hours. Conjunctival discharge cleared by 24 hours in treated-rinsed eyes. The mean 24-hour Draize score for treated-unrinsed eyes was 5.0/110. Conjunctival redness continued to Day 4 in rinsed eyes and Day 7 in unrinsed eyes. All eyes were clear by Day 10. Alopecia and flaky skin were observed around the eye to Day 14. Lackluster cornea, white material in the conjunctival sac, and a thickening of the conjunctival sac were also observed. Rinsing did not significantly affect the severity or persistence of irritation.
Untreated-Rinsed Eyes: No corneal opacity or iritis was observed. Conjunctival redness was observed at one hour. All eyes were clear at 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No corneal opacity or iritis was observed. Conjunctival irritation persisted to Day 7, with a mean 24-hour Draize score for treated-unrinsed eyes of 5.0/110. The severity and persistence of irritation was comparable between rinsed and unrinsed eyes. The test substance is not classified as irritating under EU classifications.
- Executive summary:
One-tenth milliliter of the test material was placed in the conjunctival sac of one eye in each of nine rabbits. Three of the rabbits were further treated after a 30-second exposure by rinsing the eyes for one minute with distilled water at a rate of approximately 250 milliliters per minute.
No corneal opacity or iritis was observed. Conjunctival redness, chemosis and discharge were observed at 1 through 24 hours. The mean 24-hour Draize score for treated-unrinsed eyes was 5.0/110. Conjunctival redness continued to Day 7. All eyes were clear by Day 10. The severity and persistence of irritation was comparable between rinsed and unrinsed eyes. The test substance is not classified as irritating under EU classifications.
The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating according to the dangerous substances directive, 67/548/EEC.
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.