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EC number: 916-328-0 | 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:
- 30th October 2017 - 27th November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate
- EC Number:
- 916-328-0
- Molecular formula:
- C10H18O3
- IUPAC Name:
- Reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: O’Laughlin (Nantong) Fine Chemicals Co., Ltd.; NTA375
- Expiration date of the lot/batch: Sep 25, 2020
- Purity: CAS No. 67634-00-8: 79.45 %; CAS No.: 67634-01-9 20.28 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
The reconstructed human epidermal model EpiDerm™ (EPI-200, MatTek, Bratislava, SR) consists of normal human-derived epidermal keratinocytes, which have been cultured to form a multilayered highly differentiated model of the human epidermis. The EpiDerm™ tissues (surface 0.63 cm²) are cultured on specially prepared cell culture inserts and shipped as kits, containing 24 tissues on shipping agarose together with the necessary amount of culture media. The certificate of analysis from the EpiDerm™ model (Lot No. 25851, kit B) is presented in Annex 1.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 mins at room temperature and 60 minutes 37±1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: After exposition, tissues were thoroughly rinsed and blotted to remove the test item/controls.
- Observable damage in the tissue due to washing: None
- Modifications to validated SOP:None
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: Libra S22
- Wavelength:OD570
NUMBER OF REPLICATE TISSUES: In each time interval three tissues were used per test item, three tissues for the positive control (PC) and three tissues for negative control (NC).
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Direct MTT reduction - functional check in tubes
Functional check for this possibility was performed as follows: 50 µL of the test item was added to 1 mL MTT medium (red) and it was incubated in the incubator (37±1 °C, 5±1 % CO2, humidified) for 1 hour. At the end of
the exposure time, the presence and intensity of the staining (if any) was observed.
Concurrent MTT non-specific colour control
For this purpose 50 µL of the test item were added to 1.0 mL of water and it was kept at culture conditions (37±1 °C, 5±1 % CO2, humidified) for 1 hour. Another 50 µL of the test item were added to 2 mL of isopropyl
alcohol and it was left at 2 hours at room temperature.
PREDICTION MODEL / DECISION CRITERIA
Corrosivity potential of the test item is predicted from the relative mean tissue viabilities obtained after 3 minutes and 60 minutes of treatment compared to the negative control tissues concurrently treated with H2O.
According to the OECD TG 431 as well as to the EU Method B.40, the test item is considered to be corrosive to skin:
i) if the viability after 3-minute exposure is less than 50 %, or
ii) if the viability after 3-minute exposure is greater than or equal to 50 % and the viability after 1-hour exposure is less than 15 %.
The test item is considered to be non-corrosive to skin:
i) if the viability after 3 minute exposure is greater than or equal to 50 % and the viability after 1-hour exposure is greater than or equal to 15 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- other: Direct MTT reduction
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): 8N KOH - Duration of treatment / exposure:
- 3 mins at room temperature
60 minutes at 37±1°C - Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- AAG (3 mins)
- Value:
- 95.2
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- AAG (60 mins)
- Value:
- 104.4
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Positive Control (3 mins)
- Value:
- 7.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Positive Control (60 mins)
- Value:
- 4.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: The test item did not change colour of MTT medium from red to blue (see Figure 1). The test item does not reduce MTT directly.
- Colour interference with MTT: The colour of water/isopropyl alkohol did not change, so colour of the test item did not interfere with evaluation (see Figures 2 a, b).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The assay meets the acceptance criterion - OD570 of the NC tissues was 1.790 (3 min) and 1.747 (60 min) which is ≥ 0.8 and ≤ 2.8.
- Acceptance criteria met for positive control: Viability of tissues treated with 8N KOH after 60 minutes of treatment was 4.6 % which is < 15 %.
- Acceptance criteria met for variability between replicate measurements: CV values in all triplets of tissues were ≤ 0.3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vitro skin corrosion test using the reconstructed human epidermal model EpiDerm, Allyl Amyl Glycolate was not corrosive.
- Executive summary:
In an in vitro skin corrosion assay using a human epidermal model EpiDerm (17 -698), reconstructed human epidermis tissue was exposed to 50 µL mg of Allyl Amyl Glycolate for 3 mins at room temperature and 60 minutes at 37±1°C. Water was used for the negative control and 8N KOH was used for the positive control. After removal of the test substance, tissues were incubated with MTT for 3 hours incubation. The OD570 of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
The colour of the test substance did not interfere with the endpoint. The test substance is not directly MTT reducing. The average viability of Allyl Amyl Glycolate-treated tissues was 95.2 % of the negative control average value after 3 minutes of treatment and 104.4 % after 1 hour of treatment. The average viability of 8N KOH-treated tissues was 7.5 % of the negative control average value after 3 minutes of treatment and 4.6 % after 1 hour of treatment According to these results, Allyl Amyl Glycolate is not corrosive.
This in vitro skin corrosion assay in the human epidermal model EpiDerm is acceptable and satisfies the guideline requirement for an OECD 431 study.
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