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EC number: 700-064-6 | CAS number: 2105830-60-0
- 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:
- June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- EC Number:
- 700-064-6
- Cas Number:
- 2105830-60-0
- Molecular formula:
- Not applicable as this is a UVCB substance
- IUPAC Name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- Test material form:
- liquid
- Details on test material:
- - Molecular weight: 2800-3000
- CAS Name: Castor oil, polymer with tetrahydromethyl-1,3-isobenzofurandione
- Description: Very viscous amber liquid
- Test substance storage: At room temperature in the dark under nitrogen
- Stebility under storage conditions: Stable
- Expiry date: 01 January 2009
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm Skin Model (EPI-200)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Justification for test system used:
- Recommended test system in international guldelines (OECD and EC)
- Vehicle:
- water
- Details on test system:
- EpiDerm Skin Model (EPI-200, Lot no.: 10526 klt H).
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, hlghly differentiated model of the human epidermis. It consists of organlzed basal, spinous and granular layers, and a multi-Iayered stratum eomeum containing intercellular lamellar lipid layers arranged In patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm2) were cultured on polycarbonate membranes of 10 mm cell culture inserts. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg with 25 µl water
- Duration of treatment / exposure:
- 3 min., 1 h
- Number of replicates:
- two tissues for a 3 min exposure
two tissues for a 1 h exposure
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min. exposure
- Value:
- 108
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure
- Value:
- 108
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- no other effects
Any other information on results incl. tables
Mean tissue viability in the in vitro skin corrosion test with the Substance
3 min application viability (percentage of control) | 1 hr application viability (percentage of control) | |
Negative control | 100 | 100 |
Test Substance | 108 | 108 |
Positive control | 5 | 4 |
The Table shows the mean tissue viability obtained after 3 minutes and 1 hour treatment with the Substance compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with the Substance compared to the negative control tissues was 108% at both exposure times. Since the mean relative tissue viability for the Substance was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the Substance is considered to be not corrosive.
The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability of the 3 minutes exposure of the positive control was 5%. The maximum inter tissue variability in viability between two tissues treated identically was less than 21% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 12%. It was therefore concluded that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- It is concluded that this test is valid and that the Substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
This report describes the corrosive properties of the Substance on a human threedimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of the Substance was tested through topical application for 3 minutes and 1 hour. The study procedures described in this report were based on the most recent OECD and EC guidelines.
The Substance was a very viscous amber liquid. Since the Substance was very viscous it was applied like a solid test substance. Approximately 25 mg of the Substance with 25 μl of Milli-Q water was applied directly on top of the skin tissue. The positive control had a mean relative tissue viability after 3 minutes exposure of 5%. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter tissue variability in viability between two tissues treated identically was less than 21% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 12%, indicating that the test system functioned properly. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance.
The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with the Substance compared to the negative control tissues was 108% at both exposure times. Since the mean relative tissue viability for the test substance was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the Substance is considered to be not corrosive.
Finally, it is concluded that this test is valid and that the Substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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