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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
Endpoint summary
Administrative data
Description of key information
In an acute dermal irritation/corrosion study acc. OECD 404 with4-(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 an eye irritation/corrosion study with 4-(Methacryloyloxy)benzophenone acc. OECD 405,single ocular instillation of the test item 4-(Methacryloyloxy)benzophenone to rabbits at a dose of 0.1 g produced slight irritant effects, which were fully reversible within 48 hours in all animals.Neither mortalities nor significant clinical signs of toxicity were observed.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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)
- Specific details on test material used for the study:
- 4-(Methacryloyloxy) bezophenone 97.26 %
Benzophenone acetate: 1.95 % - 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) - 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. - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.10.2009 to 04.01.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- 4-(Methacryloyloxy) bezophenone 97.3 %
Benzophenone acetate: 1.95 % - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Healthy New Zealand White Rabbits, Crl: KBL (NZW)
- Details on test animals or tissues and environmental conditions:
- Sex: female
Body weight at the beginning of the study: > 2 kg
Age at the beginning of the study: approximately 18 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 10 x / hour
Free access to autoclaved hay and to Altromin 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) - Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,1 g per test site.
The test item was ground to a fine dust using a mortar and pestle. It was applied directly. - Observation period (in vivo):
- The animals were observed for 72 hours after dosing.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application
The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control. Only part of the test item was applied as the full amount did not fit into the eye completely.
Confirmatory Test
The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye using the procedure described. In order to confirm the response.
The eyes were not rinsed.
The eyes were examined for signs of irritation throughout the observation period.
For the calculation only the 24, 48 and 72 hour readings were used.
At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo®, lot no. H 901, expiry date: 12/2010). - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test item produced ilTitant, but no cotTosive ocular effects after instillation into the eyes of3 female rabbits (strain NZW) (Tables 3 to 5).
Neither mortalities nor significant clinical signs of toxicity were observed.
The eyes were not rinsed.
Upon fluorescein examinations at the end of the observation period of 72 h no corneal lesions were found in any animal.
1 h post application, conjunctival discharge grade 2 was observed in animal no. 1, conjunctival discharge grade 1 was observed in animals no. 2 and 3.
Conjunctival redness and chemosis were also observed in animal no. 1, 2 and 3, - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, single ocular instillation of the test item 4-(Methacryloyloxy)benzophenone to rabbits at a dose of 0.1 g produced slight irritant effects, which were fully reversible within 48 hours in all animals.
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 2001159/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 eye irritation - Executive summary:
In an eye irritation/corrosion study with 4-(Methacryloyloxy)benzophenone acc. OECD 405,single ocular instillation of the test item 4-(Methacryloyloxy)benzophenone to rabbits at a dose of 0.1 g produced slight irritant effects, which were fully reversible within 48 hours in all animals. 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 2001159/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 eye irritation
Reference
Eye irritation scores animal no.1
Animal no. 1 |
|
Single data |
Average score (24, 48 and 72 h) |
|||
|
Time post application |
|
||||
|
1 hour |
24 hour |
48 hour |
72 hour |
|
|
|
T/C |
T/C |
T/C |
T/C |
|
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Conjunctival redness |
1/0 |
1/0 |
0/0 |
0/0 |
0.33 |
|
Conjunctival chemosis |
1/0 |
0/0 |
0/0 |
0/0 |
0 |
Eye irritation scores animal no.2
Animal no. 2 |
|
Single data |
Average score (24, 48 and 72 h) |
|||
|
Time post application |
|
||||
|
1 hour |
24 hour |
48 hour |
72 hour |
|
|
|
T/C |
T/C |
T/C |
T/C |
|
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Conjunctival redness |
1/0 |
1/0 |
0/0 |
0/0 |
0.33 |
|
Conjunctival chemosis |
1/0 |
0/0 |
0/0 |
0/0 |
0 |
Eye irritation scores animal no.2
Animal no. 3 |
|
Single data |
Average score (24, 48 and 72 h) |
|||
|
Time post application |
|
||||
|
1 hour |
24 hour |
48 hour |
72 hour |
|
|
|
T/C |
T/C |
T/C |
T/C |
|
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Conjunctival redness |
1/0 |
1/0 |
0/0 |
0/0 |
0.33 |
|
Conjunctival chemosis |
1/0 |
0/0 |
0/0 |
0/0 |
0 |
T=test item, C=control
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of commissionDirective 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 and eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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