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EC number: 259-766-1 | CAS number: 55699-10-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restriction, fully adequate for assesment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- 4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile
- EC Number:
- 259-766-1
- EC Name:
- 4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile
- Cas Number:
- 55699-10-0
- Molecular formula:
- C14H19NO
- IUPAC Name:
- 2-(4-tert-butyl-3-hydroxy-2,6-dimethylphenyl)acetonitrile
- Details on test material:
- - Name of the test substance used in the study report: 4-tert-Butyl-3-hydroxy-2,6-xylylacetonitrile
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 6 -7 months
- Weight at study initiation: 3.91 - 4.32 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area 3000 cm2; wooden gnawing blocks (Typ KNH E-041) as enrichment from Abedd Lab. and Vet. Service GmbH Vienna, Austria
- Diet: 130 g/day, Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst BASEL, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- The solid test substance was minimally moistened with a suitable amount of doubly distilled water to guarantee skin contact immediately before test-substance application. Because of the natural moisture of the skin doubly distilled water was used for moistening, so that the test was carried out under conditions as physiological as possible. The test patch (2.5 cm x 2.5 cm) was covered with an amount of minimally moistened solid preparation corresponding to a dose of 0.5 g of undiluted test substance.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, flank
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed with Lutrol and Lutrol/water (1 : 1).
- Time after start of exposure: 4 h
SCORING:
Immediately after removal of the patch and approx. 1, 24, 48 and 72 h after removal of the patch. Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany) were used for reading
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Moderate erythema, observed in all animals immediately after removal of the patch. Decreased to slight erythema was still observed in all animals up to 1 hour after removal of the patch. The cutaneous reactions were reversible in all animals within 24 hours after removal of the patch.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test the substance is considered to be not corrosive or irritating to the skin.
- Executive summary:
The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (compiant with GLP), by a single topical application of an amount of 0.5 g of the test substance for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm covered with semiocclusive dressing. After removal of the patch, the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch and approximately 1, 24, 48, and 72 hours after removal. Slight or moderate erythema was observed in all animals up to 1 hour after removal of the patch. The cutaneous reactions were reversible in all animals within 24 hours after removal. The average score (24 to 72 hours) for irritation was calculated to be 0 for erythema and for edema. It was concluded that the test substance was not irritating to the skin.
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