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EC number: 473-310-0 | CAS number: 478385-88-5
- 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:
- 2003-07-16 to 2003-07-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 473-310-0
- EC Name:
- -
- Cas Number:
- 478385-88-5
- Molecular formula:
- C18H20
- IUPAC Name:
- 4-methyl-4'-[(3E)-pent-3-en-1-yl]-1,1'-biphenyl
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: about 15 weeks
- Weight at study initiation: 3.08 kg (3.05 - 3.13 kg)
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 35 - 60 %
- Air changes: not specified
- Photoperiod:12 / 12 hrs dark / hrs light
The room temperature and relative atmospheric humidity in the animal room was transiently outside the target range of 16 to 22 °C and > 40 %. This deviation did not influence the integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours after removal of patches
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap: The patch was fastened to the left side of the animal's back and kept in place by a self-adhesive fabric.
REMOVAL OF TEST SUBSTANCE
- Washing: wiping off dry
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS : The rabbits were examined for skin alterations, behavior, and general condition 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to experimental day 8. Body weight was recorded on experimental days 1 and on experimental days 5 and 8.
SCORING SYSTEM: According to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Clinical findings
After a single application to the intact dorsal skin of rabbits, for a 4 hours period of exposure under semiocclusive conditions, no signs of irritation were observed in the treated areas.
No signs of clinical toxicity were detected. - Other effects:
- Mortality
All animals survived the observation period.
Body weight
Body weight development of the treated rabbits was inconspicuous.
Any other information on results incl. tables
Table 1 Individual local findings
Animal No. |
|
Local findings on day |
|||||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected, thus the test material is not considered to be a skin irritant.
- Executive summary:
The purpose of this assay was to identify the skin irritation/corrosion potential of the test item when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.
To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with 2 further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
Under the conditions of the present study no signs of irritation were seen. The evaluation of the mean scores yields zero at all time points investigated.
In conclusion, no skin irritating potential could be detected, thus the test material is not considered a skin irritant.
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