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Diss Factsheets
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EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-08-31 to 2011-10-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guideline No. 439 and EU method B.46 in a GLP certified testing facility.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- Name: 400160
Batch no.: KL-11-038
Appearance: yellow, clear viscous liquid
Composition: UVCB, 2-Ethylhexyl esters of dimerised fatty acids, C18-unsaturated
Purity: 100% (GPC)
Production date: 24 March 2011
Expiry date: 24 March 2016
Storage: room temperature (20 ± 5 °C)
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 30 µL test item were applied on the tissue surface
- Duration of treatment / exposure:
- 60 min
- Observation period:
- not applicable (cell viability was determined after the end of treatment period)
- Number of animals:
- not applicable (this is an in vitro test)
- Details on study design:
- The human skin model test was performed with commercially available Epi-200-SIT-Kit. The EpiDermTM tissues were produced from MatTek Corporation in Ashland, USA. The day of delivery was 01 July 2010 batch: 13657
Negative control: Dulbecco’s Phosphate Buffered Saline (DPBS) without CaCl2 and MgCl2
One plate (three tissues) was used as negative control; each tissue was treated with 30 µL DPBS buffer
Positive control: Sodium dodecyl sulphate (SDS), CAS No. 151-21-3, solution in deionised H2O, 5%
One plate (three tissues) was used as positive control; each tissue was treated with 30 µL SDS-solution
Test item: BYK-400160
One plate (three tissues) was used for treatment with the test item
Experimental performance:
After dosing the tissues with negative control, positive control and test item, they were incubated at 37°C for 35 min. After 60 min a rinsing step and two incubation periods at 37°C over a total period of 42 h followed.
After incubation, a MTT assay was performed and formazan production was measured by a spectral photometer at 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: formazan production in comparison to the negative control
- Value:
- 100.9
- Remarks on result:
- other:
- Remarks:
- Time point: 60 min. Max. score: 102.5. Remarks: Result: not irritant. (migrated information)
In vivo
- Irritant / corrosive response data:
- After the treatment with the test item, the mean relative absorbance values were increased to 100.9 % in comparison to the negative control. This value is well above the threshold for irritation potential (50%).
- Other effects:
- no other effects observed
Any other information on results incl. tables
Evaluation and calculation:
The photometric absorption of the negative controls was considered as 100%. For each replicates of the test item and positive control, formazan production was calculated as % photometric absorption compared with the negative control.
% Formazan production = (OD test item resp. positive control / OD mean negative control) x 100
Table 1 Absorption values of the negative control, test item and positive control (OD at 570 nm)
Designation |
Measurement |
Negative Control |
400160 |
Positive Control |
Tissue 1 |
1 |
1.734 |
1.595 |
0.145 |
2 |
1.713 |
1.582 |
0.149 |
|
Tissue 2 |
1 |
1.504 |
1.654 |
0.143 |
2 |
1.513 |
1.626 |
0.144 |
|
Tissue 3 |
1 |
1.562 |
1.602 |
0.147 |
2 |
1.577 |
1.629 |
0.149 |
From the measured absorption values, the mean of each tissue was calculated and the mean absorption of isopropanol (0.046) was subtracted.
Table 2 Mean Absorption Values
Designation |
Negative Control |
400160 |
Positive Control |
Mean – blank (Tissue 1) |
1.678 |
1.543 |
0.101 |
Mean – blank (Tissue 2) |
1.463 |
1.594 |
0.098 |
Mean – blank (Tissue 3) |
1.524 |
1.570 |
0.102 |
Mean of the three Tissues |
1.555 |
1.569 |
0.100 |
Relative Standard Deviation |
7.1% |
1.6% |
2.1% |
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 3 % Formazan Production
Designation |
400160 |
Positive Control |
% Formazan production (Tissue 1) |
99.2% |
6.5% |
% Formazan production (Tissue 2) |
102.5% |
6.3% |
% Formazan production (Tissue 3) |
101.0% |
6.6% |
% Formazan production Mean |
100.9% |
6.5% |
All validity criteria were fulfilled.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions reported, 400160 did not exhibit any skin irritating potential.
- Executive summary:
This in-vitro human skin model test (EU method B.46 resp. OECD 439) was performed in order to evaluate the potential of 400160 to evoke skin irritation in a human-skin-model.The study was performed under GLP compliance.
400160 was spread on the surface of three sections of an EpiDermTM tissue and incubated for 60 min. The negative control consisting of Dulbecco’s phosphate buffered saline was applied to another three tissue sections. As positive control a SDS solution (50 g/L) was used for three other tissue sections. After rinsing and two incubation steps of altogether 42 h an enzyme assay to determine cell viability was performed. The tissues were incubated with MTT-reagent for 3 h. The tissues were washed with PBS, dried and transferred to a 24 -well-plate. After incubating with isopropanol at room temperature over night, the developed formazan concentration was measured in a spectral photometer at 570 nm.
The mean percentage values of formazan production were calculated in comparison to the negative control. The relative absorbance values were increased to 100.9% after the treatment with 400160. This value is well above the threshold for irritation (50%). The positive control showed a reduction of formazan production of 6.5%. All validity criteria were fulfilled
In conclusion, it can be stated that the test item 400160 is considered as non skin irritant under the experimental conditions used in this study.
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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