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Diss Factsheets
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EC number: - | CAS number: 2156592-70-8
- 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://chesar.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:
- From 16 June 2010 to 10 August 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: pending to search
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3 [4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-1α in the culture medium retained following the 42 Hhour post exposure incubation period is also determined for test materials which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end point will be used to either confirm a non-irritant result or will be used to override the non irritant result.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzene, mono-C11-C13-branched alkyl derivatives
- Cas Number:
- 2156592-70-8
- Molecular formula:
- Main component may be represented by formula C18H30
- IUPAC Name:
- Benzene, mono-C11-C13-branched alkyl derivatives
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): BAB
- Substance type: UVCB
- Physical state: clear colourless liquid
- Purity test date: 01 June 2010
- Lot/batch No.: 86364/1-10
- Expiration date of the lot/batch: 01 June 2015
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- other: not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 10 µl of the test material was applied to the epidermis surface (to ensure satisfactory contact with the positive control material the SDS solution was spread over the entire surface of the epidermis using a pipette tip (taking particular care to cover the centre)).
After 7 minutes contact time the SDS solution was re spread with a pipette tip to maintain the distribution of the SDS for the remainder of the contact period. - Duration of treatment / exposure:
- 15 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): each tissue was removed from the well using forceps and rinsed using a wash bottle containing PBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: cell viability % (obtained from optical density)
- Value:
- 97.8
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Reversibility: other: not applicable. (migrated information)
- Other effects / acceptance of results:
- The relative mean viability of the test material treated tissues was 97.8% after a 15 minute exposure.
The MTT solution containing the test material did not turn blue/purple which indicated that the test material did not directly reduce MTT.
Any other information on results incl. tables
Mean OD540 Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material:
Material |
OD540 of tissues |
Mean OD540 of triplicate tissues |
± SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Material |
0.687 |
0.687 |
0.007 |
100.0 |
100* |
1.0 |
0.681 |
99.1 |
|||||
0.694 |
101.0 |
|||||
Positive Control Material |
0.105 |
0.067 |
0.035 |
15.3 |
9.7 |
5.1 |
0.060 |
8.7 |
|||||
0.035 |
5.1 |
|||||
Test Material |
0.654 |
0.672 |
0.030 |
95.2 |
97.9 |
4.4 |
0.656 |
95.5 |
|||||
0.707 |
102.9 |
SD = Standard deviation
* = The mean viability of the negative control tissues is set at 100%
Following the 15-Minute exposure period the test material treated tissues appeared blue which was considered indicative of viable tissue.
Due to the absence of cytotoxicity in the MTT assay it was necessary to determine the concentration ofinflammatory mediator IL-1α in the retained culture medium for confirmatory purposes.
The concentration ofinflammatory mediator IL-1α in the culture medium retained from the test material treated tissues was 27.273 pg/ml. This result confirmed the absence of cytotoxicity as determined in the MTT assay.
Quality Criteria:
The relative mean tissue viability for the positive control treated tissues was ≤ 40% relative to the negative control treated tissues and the standard deviation value of the percentage viability was ≤ 18%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was ≥ 0.6 and the SD value of the percentage viability was ≤ 18%. The negative control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: other: see table above (any other information on materials and methods)
- Conclusions:
- The test material was considered to be Non-Irritant. This result was confirmed by assessment of the inflammatory mediator IL-1α.
- Executive summary:
The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKINTM reconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-1α in the culture medium retained following the 42-Hhour post-exposure incubation period is also determined for test materials which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end-point will be used to either confirm a non-irritant result or will be used to override the non-irritant result.
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was measured at 540 nm.
Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Results:
The relative mean viability of the test material treated tissues was 97.8% after a 15-Minute exposure period.
Due to the absence of cytotoxicity in the MTT assay it was necessary to determine the concentration of inflammatory mediator IL-1α in the retained culture medium for confirmatory purposes.
The concentration of inflammatory mediator IL-1α in the culture medium retainedfrom the test material treated tissues was 27.273 pg/ml. This result confirmed the absence of cytotoxicity as determined in the MTT assay.
Quality criteria:
The quality criteria required for acceptance of results in the test were satisfied.
Conclusion:
The test material was considered to be Non-Irritant. This result was confirmed by assessment of the inflammatory mediator IL-1α.
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