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EC number: 807-596-9 | CAS number: 1428451-07-3
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09.01.2015 - 19.01.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(2-bromoacetyl)-3-[(methoxycarbonyl)oxy]phenyl methyl carbonate
- EC Number:
- 807-596-9
- Cas Number:
- 1428451-07-3
- Molecular formula:
- C12H11BrO7
- IUPAC Name:
- 4-(2-bromoacetyl)-3-[(methoxycarbonyl)oxy]phenyl methyl carbonate
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Test system:
- human skin model
- Vehicle:
- water
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of post-treatment incubation (if applicable):
- 15 min
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main experiment
- Value:
- > 93.2 - < 101.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
1. Pre-Experiments
The mixture of 10 mg test item per 2 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. The mixture of 10 mg of the test item per 90 μL aqua dest. showed no colouring detectable by unaided eye-assessment.
2. Experiment
Table 1: Result of the test with 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone
Name |
Negative Control (NC) |
Positive Control (PC) |
Test Item |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
absolute OD550 |
0.937 0.911 |
0.923 0.960 |
0.934 0.937 |
0.116 0.119 |
0.129 0.125 |
0.115 0.110 |
0.911 0.917 |
0.857 0.889 |
0.963 0.932 |
OD550(blank-corrected) |
0.893 0.867 |
0.880 0.916 |
0.890 0.893 |
0.072 0.076 |
0.085 0.081 |
0.071 0.066 |
0.867 0.873 |
0.814 0.845 |
0.919 0.889 |
mean OD550of the duplicates (blank-corrected) |
0.880 |
0.898 |
0.892 |
0.074 |
0.083 |
0.068 |
0.870 |
0.829 |
0.904 |
total mean OD550of 3 replicate tissues (blank corrected) |
0.890* |
0.075 |
0.868 |
||||||
SD OD550 |
0.009 |
0.007 |
0.037 |
||||||
relative tissue viabilities [%] |
98.9 |
100.9 |
100.2 |
8.3 |
9.3 |
7.7 |
97.7 |
93.2 |
101.6 |
mean relative tissue viability [%] |
100.0 |
8.4** |
97.5 |
||||||
SD tissue viability [%]*** |
1.0 |
0.8 |
4.2 |
||||||
CV [% viability] |
1.0 |
9.9 |
4.3 |
* Corrected mean OD550 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the three positive control tissues is≤40%
*** The standard deviation (SD) obtained from the three concurrently tested tissues is < 18 %.
3. Quality Criteria
Table 2: Qualitiy Criteria
|
Value |
Cut off |
pass / fail |
Mean OD550blank |
0.044 |
< 0.1 |
pass |
Mean Absolute OD550NC |
0.934 |
0.6 ≤ NC ≤ 1.5 |
pass |
Mean Relative Viability [%] PC |
8.4 |
≤ 40 % |
pass |
SD of Viability [%] |
0.8 – 4.2 |
< 18 % |
pass |
4. Historical Data
Table 3: Historical Data
|
OD550blank |
Absolute OD550NC |
Relative Viability [%] PC |
SD of Viability [%] |
Mean |
0.043 |
0.869 |
12.50 |
8.01 |
SD |
0.002 |
0.122 |
8.67 |
8.63 |
n |
44 |
44 |
44 |
176 |
5. Dicussion and Conclusion
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human skin model EPISKIN-SM TM (SkinEthic) comprising a reconstructed epidermis with a functional stratum corneum. In the present study 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone was applied topically to the EPISKIN-SM TM tissue for 15 min. followed by a 42 h postincubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with PBS. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (102.3%) after 15 min. treatment and 42 h post incubation. The controls confirmed the validity of the study. The mean OD550 of the six blank values was < 0.1. The mean absolute OD550 of the three negative control tissues was≥ 0.6 and≤ 1.5.The mean relative tissue viability (% negative control) of the positive control was 40 % (8.4 %). The maximum standard deviation of the viability of replicate tissues of all dose groups was < 18 % (0.8 - 4.2 %)
Under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone was not irritating in an in vitro skin irritation test (reconstructed human epidermis test method) according to OECD 439 and EU-Method B.46.
- Executive summary:
In the present study the skin irritant potential of 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone was analysed. The EPISKINStandard Model™ (EPISKIN-SMTM), a reconstituted three-dimensional human epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404) to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 15 min exposure and 42 h post incubation period and compared to those of the concurrent negative controls.
Under the given conditions 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone showed no irritant effects. The relative mean tissue viability after 15 min of exposure and 42 h post incubation was > 50%. The test item is therefore classified as“non-irritant” in accordance with UN GHS “No Category”.
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