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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 irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
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
- Reference substance name:
- [TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
- IUPAC Name:
- [TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
- Details on test material:
- Multiester P97-463
Batch No.: NB2890-61
Constituent 1
Constituent 2
Test animals
- Species:
- other: Human Skin Model
- Strain:
- other: EpiDerm Skin Model
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 25 mg with 25 µl water
- Duration of treatment / exposure:
- 3 min and 1 hour
- Observation period:
- not applicable
- Number of animals:
- 0
- Details on study design:
- two tissues for a 3 min exposure
two tissues for a 1 h exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Human Skin Model
- Basis:
- other: not applicable
- Time point:
- other: 3 min
- Score:
- 108
- Max. score:
- 108
- Reversibility:
- no data
- Remarks on result:
- other: The score is tissue viability as percentage of control
- Irritation parameter:
- other: Human Skin Model
- Basis:
- other: not applicable
- Time point:
- other: 1 h
- Score:
- 108
- Max. score:
- 108
- Reversibility:
- no data
- Remarks on result:
- other: The score is tissue viability as percentage of control
- Other effects:
- no other effects
Any other information on results incl. tables
Mean tissue viability in the in vitro skin corrosion test with Multiester P97-463
3 min application viability (percentage of control) | 1 hr application viability (percentage of control) | |
Negative control | 100 | 100 |
Multiester P97-463 | 108 | 108 |
Positive control | 5 | 4 |
The Table shows the mean tissue viability obtained after 3 minutes and 1 hour treatment with Multiester P97-463 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 Multiester P97-463 compared to the negative control tissues was 108% at both exposure times. Since the mean relative tissue viability for Multiester P97-463 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment Multiester P97-463 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
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not corrosive
- Executive summary:
It is concluded that this test is valid and that Multiester P97-463 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
This report describes the corrosive properties of Multiester P97-463 on a human threedimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of Multiester P97-463 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.
Batch NB2890-61 of Multiester P97-463 was a very viscous amber liquid. Since Multiester P97-463 was very viscous it was applied like a solid test substance. Approximately 25 mg Multiester P97-463 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 Multiester P97-463 compared to the negative control tissues was 108% at both exposure times. Since the mean relative tissue viability for Multiester P97-463 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment Multiester P97-463 is considered to be not corrosive.
Finally, it is concluded that this test is valid and that Multiester P97-463 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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