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EC number: 911-351-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 06 March 2012 and 08 March 2012.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline for the testing of chemicals 431
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2011-08-31
Test material
- Reference substance name:
- Reaction Mass of Diisobutyl hydrogen phosphate and Isobutyl dihydrogen phosphate
- IUPAC Name:
- Reaction Mass of Diisobutyl hydrogen phosphate and Isobutyl dihydrogen phosphate
- Reference substance name:
- (2-methylpropoxy)phosphonic acid; bis(2-methylpropoxy)phosphinic acid
- EC Number:
- 911-351-2
- Molecular formula:
- Not applicable
- IUPAC Name:
- (2-methylpropoxy)phosphonic acid; bis(2-methylpropoxy)phosphinic acid
- Test material form:
- other: Viscous liquid stored at room temperature
- Details on test material:
- - Name of test material (as cited in study report): Isobutyl acid phosphate (IBAP)
Constituent 1
Constituent 2
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstruted Human Epidermis
- Cell source:
- other: Culture
Test animals
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- The test item was applied neat.
- Amount(s) applied (volume or weight with unit):
50 µl of the test item was applied topically to the corresponding tissues ensuring uniform coverage of the tissues.
- Concentration (if solution):
The test item was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- 3, 60 or 240 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- Area of exposure:
50 µl of the test item was applied topically to the corresponding tissues ensuring uniform coverage of the tissues.
- % coverage:
The test item was applied topically to the corresponding tissues ensuring uniform covering.
REMOVAL OF TEST ITEM
- Washing (if done):
At the end of each exposure period, each tissue was removed from the well using forceps and rinsed using a wash 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 of PBS to gently remove any residual test item.
- Time after start of exposure: 3, 60 or 240 minutes
SCORING SYSTEM:
Quantitative MTT Assessment (percentage tissue viability)
The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3, 60 and 240-minute treatments, compared to the mean of the negative control tissues. The relative mean viabilities were calculated in the following way:
mean OD540 of test material / mean OD540 of negative control x 100 = Relative mean tissue viability (percentage of negative control)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 103.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 11.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 minutes
- Value:
- 4.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- The relative mean viability of the test material treated tissues was as follows:
240 minutes exposure: 4.1%
60 minutes exposure: 11.1%
3 minutes exposure: 103.7% - Other effects:
- No
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.
Quality Criteria:
The relative mean tissue viability for the positive control treated tissues was 8.3% relative to the negative control treated tissues following the 240-minute exposure period. The positive control acceptance criterion was therefore satisfied. The mean OD540for the negative control treated tissues was 0.217. The negative control acceptance criterion was therefore satisfied.
Table 7.3.1/1:Mean OD540Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
Exposure Period |
Mean OD540of duplicate tissues |
Relative mean viability (%) |
|
Negative Control Item |
240 Minutes |
0.217 |
100* |
|
Positive Control Item |
240 Minutes |
0.018 |
8.3 |
|
Test Item |
240 Minutes |
0.009 |
4.1 |
|
60 Minutes |
0.024 |
11.1 |
||
3 Minutes |
0.225 |
103.7 |
||
*= The mean viability of the negative control tissues is set at 100% Diisobutyl hydrogen phosphate and Isobutyl dihydrogen phosphate (IBAP)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As viability of cells is higher than 35% after 3 minutes exposure but lower than 35% after 1 hour exposure the test item is classified as corrosive to the skin, Skin Corr. 1B (H314) according to the Regulation (EC) 1272/2008 (CLP) and as C, R34 according to the Directive 67/548/EEC under the test conditions of this study.
- Executive summary:
In an in vitro skin corrosion study performed according to the OECD guideline 431 and in compliance with the GLP, Reaction Mass of "Diisobutyl hydrogen phosphate and Isobutyl dihydrogen phosphate" (purity 96%) was applied undiluted to Reconstructed Human Epidermis (RHE) model (Episkin TM model kit 0.38cm²).
Duplicate tissues were treated with the test item for exposure periods of 3, 60 and 240 minutes. At the end of the exposure period each tissue was rinsed from the test item before each tissue was taken for MTT-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 (OD540). 0.9 % (w/v) Sodium Chloride Solution was used as the negative control. Glacial Acetic Acid was used as the positive control.
The relative mean tissue viability for the positive control treated tissues was 8.3% relative to the negative control treated tissues following the 240-minute exposure period. The positive control acceptance criterion was therefore satisfied. The mean OD540for the negative control treated tissues was 0.217. The negative control acceptance criterion was therefore satisfied.
Percentage of cell viability (MTT reduction in the test item treated tissues relative to negative control tissues) was determined for each exposure period. The relative mean viability of the test item treated tissues was 103.7; 11.1 and 4.1% for exposure period of 3, 60 and 240 min, respectively.
As viability of cells is higher than 35% after 3 minutes exposure but lower than 35% after 1 hour exposure the Reaction Mass of "Diisobutyl hydrogen phosphate and Isobutyl dihydrogen phosphate" is classified as corrosive to the skin, Skin Corr. 1B (H314) according to the Regulation (EC) 1272/2008 (CLP) and as C, R34 according to the Directive 67/548/EEC.
This study is considered as acceptable as it satisfies the main criteria of OECD guideline No. 431.
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