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EC number: 470-130-4 | CAS number: 697235-49-7
- 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:
- 2004-04-26 to 2004-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2002-04-24
- Deviations:
- yes
- Remarks:
- body weight at end of study and clinical signs were missing in the study report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- , 2004
- Deviations:
- yes
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 470-130-4
- EC Name:
- -
- Cas Number:
- 697235-49-7
- Molecular formula:
- Hill formula: C16H15NO4 CAS formula: C16H15NO4
- IUPAC Name:
- 2-((3-(4-Hydroxyphenyl)propanoylamino)benzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
- Molecular formula: C16H15NO4
- Molecular weight: 285.3 g/mole
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - stock: Chbb:HM; SPF albino rabbits
- Source: Charles River Deutschland, Kißlegg, Germany
- Age at study initiation: approx. 8 months
- Weight at study initiation: 2.0 - 2.3 kg bw
- Housing: rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet (ad libitum): a pelleted complete rabbit diet "Altromin 2123" (supplier: Altromin, Lage, Lippe; Germany)
- Water (ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C
- Relative humidity: 55% ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: olive oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL olive oil - Duration of treatment / exposure:
- initial animal: 3 minutes, 1 hour and 4 hours
Confirmatory animals: - Observation period:
- immediately, 1 hour, 24 hours, 48 hours and 72 hours as well as on day 7 after termination
- Number of animals:
- 3 female rabbits
- Details on study design:
- An initial test with one animal was carried out first followed by a confirmatory test with two animals..
TEST SITE
The day before the treatment the skin area on the back of the rabbits was clipped as closely as possible with an electric clipper.
The test item was applied to a 16-layer gauze patch (2.5 x 2.5 cm) and moistened with the vehicle, the patch was placed on the skin and secured semi-occlusively with adhesive Gothaplast tape (2.5 cm). After an exposure time of 3 minutes. The first patch was removed, the treated skin was cleaned with mild soap and lukewarm water. A first assessment of the skin reaction took place immediately after the termination of exposure.
No corrosive effects were observed and a second patch with test item was applied on the rabbit back. In order to improve the patch securing the trunk of the animal was additionally wound with 5 cm wide adhesive Gothaplast tape. After an exposure time of 1 hour the second patch was removed, the treated skin was cleaned with mild soap and lukewarm water. The skin reaction was first assessed immediately after the termination of exposure.
Again no corrosive effects were observed and the exposure time was extended to 4 hours. An amount of the test item was applied on a third patch, was moistened with 0.1 ml olive oil and put on the skin. Adhesive Gothaplast tape (2.5 cm and 5 cm wide) served again as the semiocclusive securing. After a 4-hour exposure time the third patch was removed, the treated skin was cleaned with mild soap and lukewarm water. The first assessment of the skin reaction took place again immediately after the termination of exposure.
A confirmatory test with two animals was carried out after the initial test. The animals were treated the same way as in the initial test except that the animals were only exposed for 4 hours.
SCORING SYSTEM: according to the Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The animal used in the initial test showed no skin reactions immediately after the application.
1 hour after the termination of exposure no signs of skin irritation were observed at any animal.
24, 48 and 72 hours after the termination of exposure one animal showed a very slight erythema, whereas the other animals were free of any signs of skin irritation. 7 days after the termination of exposure this animal was free of any signs of skin irritation - Other effects:
- 1 hour after the termination of exposure no signs of skin
irritation were observed at the 3 animals.
24, 48 and 72 hours after the termination of exposure one of
the animals showed a very slight erythema on the anterior
right test field, whereas no skin reactions were observed
at the other two animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritating.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritating.
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