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EC number: 801-829-8 | CAS number: 1247790-47-1
- 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 8th to 9th of May, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study without deficiencies.
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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,6-dimethylheptan-2-ol
- EC Number:
- 801-829-8
- Cas Number:
- 1247790-47-1
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,6-dimethylheptan-2-ol
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermis model
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: tissues were treated with the negative control material
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl of the test material was applied topically to the corresponding tissues ensuring uniform coverage of the tissues. - Duration of treatment / exposure:
- Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes. Duplicate tissues were treated with the positive
and negative control materials for an exposure period of 240 minutes. - Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- The procedure followed is based on the recommended EpiSkin™ Skin Corrosivity Test protocol INVITTOX N°118.
Preparation of Test Item: The test item was used as supplied.
NEGATIVE AND POSITIVE CONTROLITEMS
Negative control item: 0.9% w/v sodium chloride solution
Positive control item: Glacial Acetic acid
REMOVAL OF TEST SUBSTANCE
At the end of each exposure period, each tissue was removed from the well using forceps and rinsed using a bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream pf PBS to gently remove any residual test item.
INTERPRETATION OF RESULTS:
The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3, 60 and 240-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with 0.9% w/v sodium chloride solution.
SCORING SYSTEM:
Classification of corrosivity potential was based on relative viabilities for each exposure time: see table in the following section.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: relative viability percentage of the test item (based on optical density at 540 nm)
- Basis:
- mean
- Time point:
- other: 240 minutes
- Score:
- 113.1
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: relative viability percentage of the test item (based on optical density at 540 nm)
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 134
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: relative viability percentage of the test item (based on optical density at 540 nm)
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 125.4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
DIRECT MTT REDUCTION
The MTT solution containing the test item did not turn blue. This was taken to indicate the test item did not reduce MTT.
RESULTS OF TEST ITEM, POSITIVE CONTROL AND NEGATIVE CONTROL ITEM
Mean Optical Density at 540 nm values and viabilities for the negative control, positive control and test item are given in table 1 attached.
QUALITY CRITERIA:
The relative mean tissue viability for the positive control treated tissues was 3.1% relative to the negative control treated tissues following the 240 -Minute exposure period. The positive control acceptance criterion was therefore satisfied.
The mean optical density for the negative control treated tissues was 0.911. The negative control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non-Corrosive
- Remarks:
- Criteria used for interpretation of results: other: OECD 431
- Conclusions:
- The test item was considered to be Non-Corrosive to the Skin
- Executive summary:
The purpose of this test was to evaluate the corrosivity potential of the test material using the EPISKINTMin vitro Reconstructed Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to meet the be compatible with the OECD Guideline for the Testing of Chemicals No. 431 “In VitroSkin Corrosion: Human Skin Model Test” (adopted 13 April 2004) and the Method B.40 of Commission Regulation (EC) No. 440/2008
The EPISKINTMmodel is able to distinguish between corrosive and non-corrosive chemicals for all of the chemical types studied. As stated in regulation 1272/2008/EEC a validatedin vitrotest such asin vitroskin corrosion test in the EPISKINTMmodel can be used for classification and labelling. The EPISKINTMmodel is also able to distinguish between known R35 (UN packing group I) and R34 (UN packing group II & III) chemicals.
Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes. At the end of the exposure period the test material was rinsed from each tissue before each tissue was taken for MTT (3 -[4,5 -dimethylthiazol-2 -yl]-2,5 -diphenyl-tetrazolium bromide) loading. 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 (OD) was measured at 540 nm.
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean viability of the test material treated tissues was:
240 minutes exposure
113.1%
60 minutes exposure
134.0%
3 minutes exposure
125.4%
The quality criteria required for acceptance of results in the test were satisfied.
The test item was considered to be Non-Corrosive to the skin.
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