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EC number: 611-390-2 | CAS number: 56467-43-7
- 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:
- 22.10.2009 to 02.12.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester
- EC Number:
- 611-390-2
- Cas Number:
- 56467-43-7
- Molecular formula:
- C17H14O3
- IUPAC Name:
- 2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester
- Reference substance name:
- (4-benzoylphenyl) acetate
- Cas Number:
- 13031-44-2
- Molecular formula:
- C15H12O3
- IUPAC Name:
- (4-benzoylphenyl) acetate
- Test material form:
- solid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- 4-(Methacryloyloxy) bezophenone 97.26 %
Benzophenone acetate: 1.95 %
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Healthy New Zealand White Rabbits, Crl: KBL (NZW)
- Details on test animals or test system and environmental conditions:
- Test System
Species/strain: Healthy New Zealand White Rabbits, Crl: KBL (NZW)
Source: Charles River Deutschland, D-97633 Sulzfeld
Sex: female
Body weight at the beginning of the study:> 2 kg
Age at the beginning of the study: approximately 15 weeks old
Number of animals: 3
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Housing and Feeding Conditions
Semi barrier in an air-conditioned room
Temperature: 18 ± 3°C (recommendations ofTVT, GV-SOLAS
Relative humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least I 0 x / hour
Free access to autoclaved hay and toAltromin 2123 maintenance diet for rabbits (lot no. 1411 ), rich in crude fibre
Free access to tap water (drinking water, municipal residue control, microbial. controlled periodically)
Housed in ABS -plastic rabbit cages, floor 4200 cm2
Adequate acclimatisation period (at least 5 days)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: The untreated right side served as control.
- Amount / concentration applied:
- 0.5 g per test site
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3
- Details on study design:
- Preparation of the Animals:
Approximately 24.5 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
Initial Test (in vivo Dermal Irritation/Corrosion Test using one Animal):
The test item was not expected to produce corrosion but might be irritating. Therefore, a single patch was applied to one animal for 4 hours.
Application:
The test item was applied first to a gauze patch at a single dose. To ensure good skin contact, it was moistened with aqua ad injectionem (B. Braun Melsungen, lot no. 7494Al91, expiry date: 1112010). The patch was then applied to the skin on a small area ( approx. 6 cm2 ) on the left side of the dorsal area. The gauze was held in place with non-irritating tape. The untreated right side served as control. The patch was fixed with a semi-occlusive dressing. The limits of the application site were marked with an ink marker.
Dose Level:
A dose of 0.5 g of the test item was applied to each test site.
Exposure Period:
The test item was held in contact with the skin throughout a 4-hour period. At the end of the exposure period the residual test item was removed by using aqua ad injectionem.
Confirmatory Test:
The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the skin using the procedure described. In order to confirm the response,
two additional animals were treated in the same manner.
Observation Period:
All animals were observed for 72 hours after the patch removal.
Clinical Observation
For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 1 hour as well as 24, 48 and 72 hours after patch removal. Dermal irritation was scored and recorded according to the grades inthe table below. Any other signs such as hyperplasia, scaling,
discoloration, fissures and scabs or any systemic effects were also recorded. For the initial test in one animal, the test site was also examined immediately after the patch has been removed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no significant body weight changes during the contact and observation period
Any other information on results incl. tables
Dermal irritation evaluation:
|
|
Irritation (hours after patch removal) |
|||||||
Animal No. |
Appl. site |
1 hour |
24 hours |
48 hours |
72 hours |
||||
|
|
erythema |
oedema |
erythema |
oedema |
erythema |
oedema |
erythema |
oedema |
1 |
Test item |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Test item |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Test item |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item 4-(Methacryloyloxy)benzophenone to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item 4-(Methacryloyloxy)benzophenone does not have to be classified and has no obligatory labelling requirement for skin irritation. - Executive summary:
In an acute dermal irritation/corrosion study acc. OECD 404 with 4-(Methacryloyloxy) benzophenone by single dermal application to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item
4-(Methacryloyloxy)benzophenone does not have to be classified and has no obligatory labelling requirement for skin irritation.
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