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EC number: 204-265-5 | CAS number: 118-61-6
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.12.2016-19.01.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 30 May 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- Ethyl salicylate
- EC Number:
- 204-265-5
- EC Name:
- Ethyl salicylate
- Cas Number:
- 118-61-6
- Molecular formula:
- C9H10O3
- IUPAC Name:
- ethyl 2-hydroxybenzoate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
- Source: MatTek Corporation
- Cell culture: The EpiDerm™ tissues (surface 0.63 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm Ø).
- Pre-incubation period: pre-incubation phase of the EpiDerm™ tissues started on the day of receipt.
- Treatment: EpiDerm tissues were treated with the test substance
- Amount/test concentration: 50 µL
- Duration of treatment: 3 minutes, 60 minutes
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure : room tempeature
- Temperature of post-treatment incubation (if applicable): 37+-1.5°C
CONTROL
- Negative Control: 50 µL deionised water was used as negative control per tissue;
- Positive Control: 50 µL 8.0 N potassium hydoxide (Sigma) was used a positive control per tissue
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing (if done): Tissues washed with DPBS at least 20 times in order to remove any residual test material. Exess DPBS was removed by gently shaking the tissue inserts and blotting the lower surface with blotting paper.
SCORING SYSTEM:
Viability measured using MTT assay
mean tissue viability < 50% after 3 minutes exposure: corrosive
mean tissue viability ≥ 50% after 3 minutes exposure AND < 15% after 60 minutes exposure: corrosive
mean tissue viability ≥ 50% after 3 minutes exposure AND = 15% after 60 minutes exposure: non-corrosive
Test Item Identified as Corrosive:
< 25% after 3 minutes exposure: Optional Sub-category 1A
≥ 25% after 3 minutes exposure: A combination of optional Sub-categories 1B and 1C
Historical data positive control:
Mean Viability: 21.60% (3 min), 7.02% (1 h); CV: 9.52% and 14.72%, respectively;
Range of Viabilities: 4.60 – 39.83%.
Historical data negative control:
Mean Absorption: 1.68 (3 min), 1.65 (1 h); CV:
4.87 and 3.19, respectively;
Range of Absorbance: 1.34 – 1.93 (3 min) and 1.32 – 1.85 (1h)
Acceptability of the assay:
An assay met the acceptance criteria if
- the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time
- the mean viability of the tissue replicates treated with the positive control for 1 hour is <15% compared to the negative control
- the Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- - Test item: 50 μL (79.4 μL/cm2 according to guideline) of undiluted test item
- Controls: each 50 μL - Duration of treatment / exposure:
- 3 minutes; 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min. incubation time
- Value:
- >= 111.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not considered to be corrosive.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour incubation time
- Value:
- >= 117.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not considered to be corrosive
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: test item did not reduce MTT
- Colour interference with MTT:it did not change colour
- After exposure to the negative control the absorbance values met the required acceptability criterion of a mean OD570 ≥ 0.8 and ≤ 2.8 for both treatment intervals thereby confirming the acceptable quality of the tissues.
Any other information on results incl. tables
Results after treatment with the test item and the controls
Dose Group | Exposure Interval (min) | Mean Absorbance (OD) of 2 tissues |
Stand. Dev. [%] |
Mean Rel. Absorbance [% of Negative Control] |
Negative Control | 3 | 1.577 | 3.1 | 100 |
Test Item | 1.765 | 2.2 | 111.9 | |
Positive Control | 0.459 | 3.4 | 29.1 | |
Negative Control | 60 | 1.518 | 0.3 | 100 |
Test Item | 1.782 | 1.9 | 117.4 | |
Positive Control | 0.153 | 12 | 10.1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item is non corrosive to skin according to EU CLP and UN GHS.
- Executive summary:
This in vitro study was performed to assess the corrosive potential of the test item by means of the Human Skin Model Test with EpiDerm™ tissues models. The test was performed according to OECD 431 and EU-Method B.40 and in compliance to GLP.
The test item passed the colour and the MTT interference pre-tests. Independent duplicate tissues of EpiDerm were exposed to the test item, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and 1 hour, respectively.
Afterwards, the test and the control items were rinsed off the tissues, and a 3 hour incubation period (37 ± 1 °C, 5 ± 0.5 % CO2) with MTT solution followed. MTT solution was then aspirated from the wells and the wells were rinsed with DPBS. Inserts were transferred into new 24 well plates. The formazan salt was extracted for about 22.5 hours. The required acceptability criteria were met.
Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 minutes exposure period (29.1%) and for the 1 hour exposure period (10.1%) thus confirming the validity of the test system and the specific batch of tissue models.
After exposure to the test item the corrected relative absorbance value were not reduced both after 3 minutes exposure and after 1 hour exposure (111.9% and 117.4%, respectively). Therefore, the test item is not considered to be corrosive.
In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item is non corrosive to skin according to EU CLP and UN GHS.
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