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EC number: 272-902-4 | CAS number: 68919-76-6
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-09-25 to 2013-01-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD 439 and EU method B.46 in a GLP certified testing facility.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- Test material form:
- other: liquid
- Details on test material:
- Name 400112
Batch no. 0001273679
Appearance yellow-brown, liquid
Composition UVCB substance
Purity 100% (not purified but used as synthesised)
Production date May 2011
Expiry date May 2013
Storage Room Temperature: 20 ± 5°C
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 microliter
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter
- Concentration (if solution): - Duration of treatment / exposure:
- 35 minutes at 37°C
- Number of replicates:
- 3 for each sample and control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- formation of formazan from MTT was determined being a measure of cell viability.
- Run / experiment:
- 1
- Value:
- 3.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- formation of formazan from MTT was determined being a measure of cell viability.
- Run / experiment:
- 2
- Value:
- 3.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 4.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value refers to % formazan production
Any other information on results incl. tables
Blank:
As blank, the optical density of isopropanol was measured in eight wells of the 96-wellplate.
Mean value:0.061
Table 1: Absorption values of the negative control, test item and positive control (OD at 570 nm)
Tissue no. |
Measurement |
Negative Control |
400112 |
Positive Control |
1 |
1 |
2.132 |
0.429 |
0.214 |
2 |
2.151 |
0.425 |
0.211 |
|
2 |
1 |
2.044 |
0.440 |
0.215 |
2 |
2.084 |
0.445 |
0.216 |
|
3 |
1 |
2.028 |
0.452 |
0.222 |
2 |
2.044 |
0.469 |
0.225 |
From the measured absorption values, the mean of each tissue was calculated. From the mean absorption values the mean absorption of isopropanol (0.061) was subtracted. Mean and relative standard deviations (comparison of the three tissues) were also calculated.
Table 2: Mean absorption values subtracted by the mean absorption of the blank
Tissue no. |
Negative Control |
400112 |
Positive Control |
1 |
2.081 |
0.366 |
0.152 |
2 |
2.003 |
0.382 |
0.155 |
3 |
1.975 |
0.400 |
0.163 |
Mean of the three tissues |
2.020 |
0.383 |
0.157 |
Relative standard deviation |
2.7% |
4.4% |
3.6% |
Table 3: Mean absorption values of freeze killed tissues of negative control and test item (OD at 570 nm)
Tissue no. |
Negative Control |
400112 |
1 |
0.093 |
0.380 |
2 |
0.087 |
0.400 |
3 |
0.088 |
0.399 |
Mean of the three tissues |
0.090 |
0.393 |
The mean OD of the untreated freeze-killed tissue is subtracted from the mean OD of the treated freeze-killed tissue (= 0.304). This difference is then subtracted from the OD of the test item in the test. The calculated value is the “OD corrected”.
Corrected Values Viable Tissues
The absorption values of the negative and positive control and the corrected absorption values of the test item are given in the following table:
Table 4: Mean absorption values
Tissue no. |
Negative Control |
400112 (corrected) |
Positive Control |
1 |
2.081 |
0.062 |
0.152 |
2 |
2.003 |
0.078 |
0.155 |
3 |
1.975 |
0.096 |
0.163 |
Mean of the three tissues |
2.020 |
0.079 |
0.157 |
Relative standard deviation of the three tissues |
2.7% |
21.3% |
3.6% |
Comparison of Formazan Production
For the test item and the positive control, the following percentage values of formazan production were calculated in comparison to the negative control:
Table 5: % Formazan production
Tissue no. |
400112 |
Positive Control |
1 |
3.1% |
7.5% |
2 |
3.9% |
7.7% |
3 |
4.8% |
8.1% |
Mean of % formazan production |
3.9% |
7.8% |
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant according to EU regulation
- Conclusions:
- 400112 is considered irritant in the Human Skin Model Test.
- Executive summary:
To determine the Skin Irritation Potential of 400112 the Human Skin Model Test following EU-Method 8.46 resp. OECD 439 was conducted.
Three tissues of the human skin model EpiDerm™ were treated with the test item 400112 for 60 min. 30 µL of the liquid lest item were applied to each tissue (using a nylon mesh) and spread to match the tissue size (0.63 cm²). DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable for the positive and negative control (< 18%).
After the treatment with the test item 400112, the relative absorbance values were reduced to 3.9%. This value is well below the threshold for irritation potential (50%).
Therefore, 400112 is considered as irritant in the Human Skin Model Test.
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.
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