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Diss Factsheets
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EC number: 212-215-9 | CAS number: 769-92-6
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted prior to GLP, no guideline followed as none was available in 1982 (OECD 401: 1987). However, the available information is documented sufficiently and allows the conclusion that the study was properly conducted with a scientifically acceptable method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.41
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- p-tert-butylaniline
- EC Number:
- 212-215-9
- EC Name:
- p-tert-butylaniline
- Cas Number:
- 769-92-6
- Molecular formula:
- C10H15N
- IUPAC Name:
- 4-tert-butylaniline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: W. Ostrop / Meerbusch
- Weight at study initiation: 2.7 kg (average)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): "Mümmel Z" (Ssniff, Soest), ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: both sides clipped, one side also abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µL - Duration of treatment / exposure:
- 24h
- Observation period:
- 8d
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 8x8cm on the back (each side)
- Type of wrap if used: gauze patch (2.5 x 2.5 cm) applied to the skin, held in contact with the skin by indifferent, impermeable PVC film (5x5 cm), fixed by Leukoflex.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h
OBSERVATION TIME POINTS: 1, 24, 48, 72h and 8d
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: grey-white (24h), later (72h) red-brown, dry leather-like eschar, coming off after 8 days. Starting scarred recovery.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The study was conducted according to Code of Federal Regulations, Title 16, Section 1500.41 on the registered substance itself. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the skin irritating properties of the test substance in rabbits. The primary irritation index was calculated from the individual results, this resulted in mean value of 4 for edema in all tested animals, grey-white (24h), later (72h) red-brown, dry leather-like eschar has been observed, coming off after 8 days (starting scarred recovery) and hence, the substance has to be classified as corrosive to the skin.
- Executive summary:
In a skin irritation study ( Code of Federal Regulations, Title 16, Section 1500.41), male rabbits (six animals, New Zealand White) were dermally exposed to 500 µL of test substance for 24 hours. Animals then were observed for 8 days; the primary irritation index was calculated from the results.
This resulted in a primary irritation index of 4 for edema in all tested animals; further, grey-white (24h), later (72h) red-brown, dry leather-like eschar has been observed, coming off after 8 days (starting scarred recovery) and hence, the substance has to be classified as corrosive to the skin.
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.
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