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EC number: 406-040-9 | CAS number: 125643-61-0
- 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
- Study period:
- From June 13th, 1989 to June 16th, 1989.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the OECD TG 404 and to GLP, however with following deviation: testing was conducted under occlusive conditions instead of semiocclusive as recommended by the guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 406-040-9
- EC Name:
- -
- Cas Number:
- 125643-61-0
- Molecular formula:
- C24-26 H40-44 O3
- IUPAC Name:
- C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- Physical properties: yellow liquid, insoluble in water
Storage conditions: room temperature
Validity: May 1992
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approximately 12-14 weeks
- Weight at study initiation: 2290-2380 g
- Housing: individually in metal cages (and identified by individually numbered ear tags)
- Diet (e.g. ad libitum): standard rabbit pellet (Nafag No. 814, Gossau, Switzerland) ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h
All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
The drinking water quality fulfilled the critical parameters in the specification of the "Schweizerisches Lebensmittelbuch" (Edition 1972).
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A control gauze patch moistened with distilled water was applied to the contralateral flank.
- Amount / concentration applied:
- A gauze patch (approx. 12-16 cm ) bearing 0.5 mL of the test substance was applied to the right flank of each animal. The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches; skin reaction was assessed according to the OECD scoring system. Moreover, the animals were checked daily for systemic symptoms and mortality.
- Number of animals:
- 3 male animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (mean)
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: 24-48-72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Erythema graded 1 was seen in all 3 animals at reading time point 1 hour and persisted until 24 hours in only one case. After 48 hours, recovery was complete.
- Irritation parameter:
- edema score
- Remarks:
- (mean)
- Basis:
- animal: 1, 2, 3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: None of the animals showed edema
- Irritant / corrosive response data:
- The substance applied for 4 hours to the skin of rabbit under occlusive conditions induced very slight erythema in all 3 animals but no edema. Erythema was seen at reading time point 1 hour following removal of the dressing and was graded 1(max. 4). At reading time point 24 hour, very slight erythema persisted in one of the 3 animals. At reading time point 48 hour, reversibility was completed in all 3 animals.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU 67/548/EEC and EC/1271/2008
- Conclusions:
- Under the experimental conditions employed the test article induced minimal erythema reactions well below the threshold of significance when applied to the clipped albino rabbit skin.
- Executive summary:
The substance was applied for 4 hours to the skin of 3 male rabbits according to the OECD TG 404, but under occlusive conditions. The treatment induced very slight erythema in all 3 animals but no edema. Erythema was seen at reading time point 1 hour following removal of the dressing and was graded 1(max. 4). At reading time point 24 hour, very slight erythema persisted in one of the 3 animals. At reading time point 48 hour, reversibility was completed in all 3 animals. Based on the scoring of the skin findings as recommended by the OECD guideline, the test item was not irritating to the skin of rabbit.
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