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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: CFR 1500.41 - Method of testing primary irritant substances.
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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 2.0 kg.
- Housing: Cages
- Diet: Not specified
- Water: Not specified
- Acclimation period: A minimum of 7 days
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied per test site: 0.5 mL - Duration of treatment / exposure:
- Single application.
- Observation period:
- 72 hours
- Number of animals:
- 6 animals per test group.
- Details on study design:
- Study Design:
The hair on the back of healthy appearing animals was clipped prior to administrationg using a small animal clipper, the leftside of each rabbit was abraded while the right side was left intact.
0.5 mL of test solution was drawn up in a 1 cc sterile syringe and put under a 2,5 x 2,5 cm two ply sqaure gauze patch which was placed on the test sites. dermicel tape was placed around the border of the patch. Dental dam was wrapped around the back and held in place by several wrappings of Elastoplast tape. The rabbits were put in Newmann harnesses and returned to their cages for 24 hours. After the 24 hour exposure the harnesses and wrappings were removed.
Observations:
obersevations of erythema and edema at 24 hours and 72 hours post treatment intact and abraded.
SCORING SYSTEM: according to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- As the irritation was not fully reversible within 72 hours, the test substance is considered to be irritant.
Any other information on results incl. tables
The abraded skin had a similar response to the test substance as the intact skin.
See Illustration- Overall remarks,
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- An acute skin irritation study with XC-132 on rabbits was performed similar to OCED 404 guidance. A single occlusive application of XC-132 to rabbit skin for 24 hours elicited redness to the skin. No reversibility was shown after 72 hours. Therefore, XC-132 is classified for skin irritation according to GHS and CLP criteria.
- Executive summary:
In an skin irritation study with rabbits, performed according FHSA procedures (CFR 1500.41), similar to OECD 404 0.5 mL of test solution under a 2,5 x 2,5 cm two ply sqaure gauze patch was applied on clipped skin and occlusivly covered with a Newmann harnesses for 24 hours. XC-132 elicited redness to the skin after 24 hours with no sign of reversibility after 72 hours. Based on the results, the substance is classified for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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.
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