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EC number: 403-920-4 | CAS number: 107551-67-7 G 19-675 ZP
- 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 Mar. 1, 1988 to Mar. 25, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guideline, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
- EC Number:
- 403-920-4
- EC Name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
- Cas Number:
- 107551-67-7
- Molecular formula:
- C13H18O3
- IUPAC Name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propanoic acid
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 old.
- Weight at study initiation: Between 2570 to 2630 g.
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C.
- Humidity (%): 30-70%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g.
Gauze patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy Ltd.). - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: An area of at least 36 cm^2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch was 20 cm.
- Type of wrap if used: The patches were loosely covered with an aluminum foil (36 cm^2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours.
SCORING SYSTEM: OECD scoring system (OECD guideline No. 404); EC classification (EC Directive No. 83/467/ July 29, 1983).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- 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
- Other effects:
- Grade 1 erythema was noted in one animal at 1 hour. No skin
reactions were observed. Individual body weights reported at start and end of test.
Any other information on results incl. tables
Table 1 Individual skin reaction score
|
Erythema |
Edema |
||||
animal No. |
37/M CF/TF |
3 8/M CF/TF |
3 9/M CF/TF |
37/M CF/TF |
38/M CF/TF |
3 9/M CF/TF |
after 1' hr. |
0/0 |
0/0 |
0/1 |
0/0 |
0/0 |
0/0 |
after 24 hrs. |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
after 48 hrs. |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
after 72 hrs. |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
mean 24-72 hrs. |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
CF = control flank TF = test flank
M = male
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Under the experimental conditions the substance induced slight erythema when applied to the clipped albino rabbit skin. There reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, the test item can be classified as non-irritant according to the EC Directive No. 83/467/1983.
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