Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-185-8 | CAS number: 104-21-2
- 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:
- 2015-10-27 to 2015-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-methoxybenzyl acetate
- EC Number:
- 203-185-8
- EC Name:
- p-methoxybenzyl acetate
- Cas Number:
- 104-21-2
- Molecular formula:
- C10H12O3
- IUPAC Name:
- 4-methoxybenzyl acetate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- In an international prevalidation study performed by ECVAM, the in vitro skin irritation test using the human skin model EpiDerm™ and EpiSkin™ and measurement of cell viability by dehydrogenase onversion of MTT into a blue formazan salt have turned out as a sufficiently promising predictor for skin irritancy potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200- SIT Kit
- Tissue batch number: Lot No.: 23303
- Delivery date: 2015-11-17
- Date of initiation of testing: 2015-11-17 (pre-incubation)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 35 minutes at 37 ± 1.5 °C, 25 min at room temperature
- Temperature of post-treatment incubation: 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: at least 15 times, volume not provided
- Observable damage in the tissue due to washing: no data provided
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Versamax® Molecular Devices, Softmax Pro, version 4.7.1
- Wavelength: 570 nm
- Filter: 570 ± 1 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Positive Contro: mean 4.77 %, range 4.00 % - 5.90 %
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the colour did not turn blue/purple, the test item was not considered to be a MTT reducer.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the mean tissue viability is ≤ 50 %.
- The test substance is considered to be non-irritant to skin if the mean tissue viability is > 50 % - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 30 μL (47 μL/cm2)
- Concentration: unchanged
NEGATIVE CONTROL
- Amount applied: 30 μL DPBS
POSITIVE CONTROL
- Amount applied: 30 μL
- Concentration: 5 % SLS solution in deionised water - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- post-treatment: 42 hours and 38 minutes
MTT: 3 h treatment and 69 h extraction - Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 103.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 4.4 % tissue viability
- Remarks on result:
- no indication of irritation
In vivo
- Other effects:
- The optical pre-experiment to investigate the test item’s colour change potential in water did not led to a change in colour.
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
Any other information on results incl. tables
Dose Group |
Exposure Interval |
Absorbance 570 nm Tissue 1* |
Absorbance 570 nm Tissue 2* |
Absorbance 570 nm Tissue 3* |
Mean Absorbance of 3 Tissues |
Rel. Absorbance [%] Tissue 1, 2 + 3** |
Relative Standard Deviation [%] |
Mean rel. Absorbance [% of Negative Control]*** |
Negative control |
1 h |
1.402 |
1.549 |
1.502 |
1.484 |
|
5.1 |
100 |
Positive control |
1 h |
0.066 |
0.064 |
0.067 |
0.066 |
|
2.7 |
4.4 |
Test item |
1 h |
1.677 |
1.27 |
1.657 |
1.535 |
|
14.9 |
103.4 |
* Mean of three replicate wells after blank correction
** relative absorbance [rounded values]: (100x(absorbance tissue)/ mean absorbance negative control
*** relative absorbance [rounded values]: (100x(mean absorbance test item/positive control))/ mean absorbance negative control
The mean relative absorbance value of the test item, corresponding to the cell viability, was 103.4 % (threshold for irritancy:≤50 %), consequently the test item was not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was determined to be non-irritant in the in vitro human skin model test with EpiDerm.
- Executive summary:
The in vitro Human Skin Model Test with EpiDerm study according to OECD 439 was performed to assess the irritation potential of the test substance. Independent triplicate tissues of EpiDerm were exposed to either the test item, the negative control (DPBS) or the positive control (5 % SDS in water) for 1 hour. 30 μL of the test item were dispensed directly onto triplicate EpiDerm tissue surface, and spread to match the surface of the tissue. After exposure of the tissues to the test substance the mean tissue viability was 103.4 % after 1 h exposure. This value is above the threshold for irritation, which is defined to be < 50 %. Therefore, the test substance was considered to be not skin irritating. In conclusion, it can be stated that in this study and under the reported experimental conditions, the test was not irritating to skin according to EU CLP and UN GHS.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.