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EC number: 201-729-9 | CAS number: 87-19-4
- 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:
- 21.09.-10.10.2016
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted July 28, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Mnisterium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Mainzer Strasse 80, 65189 Wiesbaden, Germany
Test material
- Reference substance name:
- Isobutyl salicylate
- EC Number:
- 201-729-9
- EC Name:
- Isobutyl salicylate
- Cas Number:
- 87-19-4
- Molecular formula:
- C11H14O3
- IUPAC Name:
- 2-methylpropyl 2-hydroxybenzoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm TM tissues (Epi-200-SIT Kit)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200-SIT Kit
- Tissue batch number(s):23361
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C+/-1.5°C for 35min and at room temperature until the end of the treatment
- Temperature of post-treatment incubation (if applicable):37+/-1°C
CONTROL
- Negative Control: 30 µL DPBS (Gibco) was used as negative control per tissue;
- Positive Control: 30 µL of a 5% SLS solution in deionised water (MatTek) was used a positive control per tissue, freshly prepared prior to the start of the experiment.
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissues rinsed with DPBS at least 15 times, then submerged in DPBS at least 3 times, then once again rinsed with sterile DPBS from inside and outside.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Versama Molecular Devices, Softmax Pro, version 4.7.1
- Filter: 570 nm
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: test item does not reduce MTT, therefore, additional test was not performed
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
Viability measured using MTT assay
mean tissue viability < 50%; irritant (I), H315 (category 2)
mean tissue viability > 50%; non-irritant (NI)
Amount/concentration applied:undiluted
Duration of treatment / exposure:60 minutes - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30µL undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30µL undiluted
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 92.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: 30µL of the test substance were added to 0.3 mL of deionised water. The mixture was incubated for 60min at 37 +/-1.5°C, 5 +/-0.5% CO2. At the end of the exposure, the presence and the intensity of the staining were evaluated.
The test item did not dye water or did not change colour in presence of water.
- Colour interference with MTT:30µL of the test substance were added to 1 mL of the MTT-solution (1mg/mL) and was incubated for 60min at 37 +/-1.5°C, 5 +/-0.5% CO2. Untreated MTT medium was used as control.
MTT solution did not turn blue/purple in presence of the test item. The test substance was not considered to reduce MTT.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Results after treatment and the controls:
Dose Group | Exposure internal | Tissue No. | Absorbance 570 nm Well 1 | Absorbance 570 nm Well 2 | Absorbance 570 nm Well 3 | Mean Absorbance of 3 wells | Mean Absorbance of three wells blank corrected | Mean Absorbance of 3 tissues after blank correction* | Rel. Absorbance (%) Tissue 1, 2 +3** | Relative Standard Deviation (%) | Mean Rel. Absorbance (% of negative control)*** |
Blank | 0.038 | 0.038 | 0.038 | 0.038 | 0.000 | ||||||
Negative Control | 60 min | 1 | 1.781 | 1.796 | 1.789 | 1.788 | 1.751 | 1.814 | 96.5 | 7.4 | 100 |
2 | 1.997 | 2.036 | 1.987 | 2.006 | 1.969 | 108.6 | |||||
3 | 1.760 | 1.756 | 1.761 | 1.759 | 1.721 | 94.9 | |||||
Positive Control | 60 min | 1 | 0.144 | 0.141 | 0.131 | 0.139 | 0.101 | 0.087 | 5.6 | 14.1 | 4.8 |
2 | 0.126 | 0.120 | 0.118 | 0.121 | 0.083 | 4.6 | |||||
3 | 0.114 | 0.123 | 0.108 | 0.115 | 0.077 | 4.3 | |||||
Test substance | 60 min | 1 | 1.785 | 1.753 | 1.756 | 1.764 | 1.726 | 1.685 | 95.2 | 7.8 | 92.9 |
2 | 1.585 | 1.556 | 1.589 | 1.576 | 1.538 | 84.8 | |||||
3 | 1.816 | 1.839 | 1.831 | 1.828 | 1.791 | 98.7 | |||||
* Mean of three replicate wells after blank correction
** Relative absorbance per tissue (rounded value)
*** Relative absorbance per treatment group (rounded value)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritant to skin according to EU CLP regulation in this study and under the experimental conditions.
- Executive summary:
This test was performed according to the OECD 439 guideline "In vitro Skin Irritation: Reconstructed Human Epidermis Test method" and under GLP.
The study was performed to assess the irritation potential of the test substance by means of the Human Skin Model Test.
The test substance did not show colour/MTT interference in the pre-test.
During the test, 30µL of the test item, the negative control (DPBS) or the positive control (5% SLS) were applied to each tissue and spread to match the surface of triplicate tissues.
After 60 minutes of treatment, the test item, the negative control and the positive control were washed off the skin tissues. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following about 70 hours extraction of the colorant from the cells.
The amount of extracted colorant was determined by photometry at 570 nm.
The acceptance criteria were met according to the OECD 439 guideline:
- Mean of negative control absorbance OD ≥ 0.8 and ≤ 2.8 (value between 1.756 and 2.036)
- Relative absorbance of positive control was ≤ 20% (value 4.8%)
- Relative standard deviation of 3 identical replicates ≤ 18% (value for test item: 7.8%, negative control 7.4% and positive control 14.1%)
The mean relative absorbance value of the test item was slightly reduced to 92.9% in comparison to the relative absorbance value of the negative control after exposure of the skin tissue to the test substance.
This value is above the threshold for irritancy of ≤ 50%.
In conclusion, it can be stated that in this study and under the experimental conditions, the test substance is not irritant to skin according to EU CLP 1272/2008 regulation criteria.
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