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EC number: 613-145-5 | CAS number: 63139-21-9
- 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:
- 2007-03-16 to 2007-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2020
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:
- (4-ethylphenyl)boronic acid
- EC Number:
- 613-145-5
- Cas Number:
- 63139-21-9
- Molecular formula:
- C8 H11 B O2
- IUPAC Name:
- (4-ethylphenyl)boronic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kifilegg
- Age at study initiation: approx. 15 weeks
- Weight at study initiation: The mean initial body weight at the start of the study was 2.88 kg
- Housing: Animals were kept separately in special rabbit cages in an air-conditioned room
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: More than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: 0.5 g of the test item was mixed with some drops of Aqua pro injectione before administration. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 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.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm^2
- Type of wrap: Fixomull® stretch, Beiersdorf
REMOVAL OF TEST SUBSTANCE
- Washing: Test material residues were wiped off
- Time after start of exposure: 4 hours after start of exposure
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
SCORING SYSTEM:
- Method of calculation: Skin changes at the application sites were evaluated according to the DRAIZE-, OECD-and EEC recommendations (see table 1).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Other effects:
- - Other adverse systemic effects: No signs of clinical toxicity were observed.
- Mortality: All animals survived the observation period.
- Body weight: Body weight development of the treated rabbits was insonspicious.
Any other information on results incl. tables
Table 2: Individual local findings (scores)
Animal No. |
Finding |
Day |
|||||||
1(1 h) |
2 (24 h) |
3 (48 h) |
4 (72 h) |
5 |
6 |
7 |
8 |
||
14 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
15 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
16 |
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 of the test item could be detected in a primary skin irritation test in rabbits according to OECD guideline 404.
- Executive summary:
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 patches and applied to the intact skin of previously shaven rabbits for 4 hours under semi-occlusive conditions. The study was performed initially with one animal and followed by the confirmatory test with two further animals according to OECD guideline 404. The first examination of the treated skin followed 1 hour after patch removal. Thereafter, examinations were performed daily for a further 7 days. Under the conditions of the present study no signs of irritation were seen.
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