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EC number: 241-533-0 | CAS number: 17540-75-9
- 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:
- December 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: CFR 1500.42 - Test for eye irritants.
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Observation period lasted 72 hours.
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-sec-butyl-2,6-di-tert-butylphenol
- EC Number:
- 241-533-0
- EC Name:
- 4-sec-butyl-2,6-di-tert-butylphenol
- Cas Number:
- 17540-75-9
- Molecular formula:
- C18H30O
- IUPAC Name:
- 4-(butan-2-yl)-2,6-di-tert-butylphenol
- 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:
- According to DHEW standards in a USDA registered, AAALAC accredited facility
- Source: Isaacs Lab Stock
- Age at study initiation: Not specified
- Weight at study initiation: at least 1.5 kg.
- Housing: In cages
- Diet: Not specified
- Water: Not specified
- Acclimation period: A minimum of 7 days
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single instillation on day 1.
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Healthy appearing animals were examined with sodium fluorescein 24 hours prior to administration of the test substance in the right eye, no abnormalities were found.
The test substance was placed in the conjunctival sac of the eye. Lids were held closed for ca 1 second after instillation of the test article.
The cornea, iris and conjunctivae where examined for 3 consequetive days and scored for irritation.
Scoring:
Cornea (a)
Opacity: degree of density (readings should be taken from most dense area)
No opacity .............................................................................................................. 0
Scattered or diffuse areas details
of iris clearly visible ................................................................................................................... 1
Easily discernible translucent area; details of iris slightly obscured ........................................... 2
Opalescent area; no details of iris visible; size of pupil barely discernible ..................................... 3
Opaque, iris invisible ............................................................. 4
Area of Cornea involved (b)
one quarter(or less) but not zero......................................................1
Greater than on quarter, but less than half.........................................2
Greater than half but less than three quarters......................................3
Greater than three quarters, up to whole area.....................................4
Score equals a x b x 5, Total maximum = 80
Iris
values (a)
Normal......................................................................................................................................... 0
Folds above normal, congestion, swelling, circumcorneal
injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive).................... 1
No reaction to light, hemorrhage, gross destruction, (any or all of these) ............................................................... 2
Score equals a x 5 total maximum = 10
Conjunctivae
a)Redness (refers to palpebral conjunctivae only)
Vessels normal......................................................................................................................................... 0
Vessels definitely injected above normal ................................................................................. 1
More diffuse,deeper crimson red; individual vessels not easily discernible............................................... 2
Diffuse beefy red ......................................................................................................................... 3
Chemosis (b)
No swelling......................................................................................................................................... 0
Any swelling above normal (includes nictitating membrane)....................................................................................................... 1
Obvious swelling, with partial eversion of lids........................................................................... 2
Swelling with lids about half closed........................................................................................... 3
Swelling with lids about half closed ro completely closed.................................................................................... 4
Discharge (c)
No discharge.......................................................................0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)...........................1
Discharge with moistening ofthe lids and hairs just adjacent to lids ...........................................................2
Dischrage with moistening of the lids and haris and considerable area around the eye..........................................................3
Score equals (a+b+c) x 2 Total maximum = 20
The total score for the eye is the sum of all scores obtained for the cornea, iris and conjunctivae.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: incl. Chemosis score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: incl. Chemosis score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: incl. Chemosis score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: incl. Chemosis score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: incl. Chemosis score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: incl. Chemosis score
- Irritant / corrosive response data:
- Slight redness to the conjunctivae was observed in all animals 24 hours after application. Effects were in 3/6 rabbits reversible within the observation period of 72 hours. Although not all results were reversible the effects were very slight, and therefore considered to be reversible within 14 days.
Any other information on results incl. tables
See illustration, Overall remarks.
Sodium fluorescein did not show any additional irritation effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The potential of test article XC-132 to cause irritation to the eye was evaluated using the rabbit according to FHSA procedures (16 CFR 1500.42) similar to OECD 405. Only slight redness of the conjunctivae was observed. Effects show to be reversible in some but not all rabbits after 72 hours, however the effects were very slight, and therefore considered to be reversible within 14 days. Therefore no classification for eye irritation according to GHS and CLP criteria is required.
- Executive summary:
The potential of compound XC-132 to cause irritation to the eye was examined according to FHSA procedure (CFR 1500.42) similar to OECD 405. 0.1 mL of the test substance was applied in the eye of the test animal. Observation occured on 1st, 2nd and 3rd day after application. Slight redness of the conjunctivae was observed. These effects were reversible in 3/6 rabbits within 72 hours, the sustained effects were very slight, and therefore considered to be reversible within 14 days.
Based on the results XC-132 , XC-132 does not have to be classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments) as no full reversibily has been proven.
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