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EC number: 247-781-6 | CAS number: 26544-38-7
- 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: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4/10/1978 to 4/13/ 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-like (QA signature), guideline study with 24 hour exposure and termination at 72 hours without evidence of reversibility
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US 16 CFR 1500.41
- Deviations:
- no
- Principles of method if other than guideline:
- The skin of six rabbits was clipped over a wide area. One side was abraded; the other side remained intact. A 0.5 ml portion of the test material was administered to the abraded and intact skin of each animal. The treated sites were covered with a gauze patch and then covered by an impervious material wrapped snuggly around the trunks. After 24 hours the wrapping were removed. Each site was evaluated at 24 and 72 hours according to method of Draize.
- GLP compliance:
- yes
- Remarks:
- Study predates GLP regulations, but QA signature is available.
Test material
- Reference substance name:
- Dihydro-3-(tetrapropenyl)furan-2,5-dione
- EC Number:
- 247-781-6
- EC Name:
- Dihydro-3-(tetrapropenyl)furan-2,5-dione
- Cas Number:
- 26544-38-7
- Molecular formula:
- C16H26O3
- IUPAC Name:
- 3-dodecenyl dihydrofuran-2,5-dione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 6 rabbits
- Details on study design:
- The skin of six rabbits was clipped over a wide area. One side was abraded; the other side remained intact. A 0.5 ml portion of the test material was administered to the abraded and intact skin of each animal. The treated sites were covered with a gauze patch and then covered by an impervious material wrapped snuggly around the trunks. After 24 hours the wrapping were removed. Each site was evaluated at 24 and 72 hours according to method of Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.75
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- Abraded
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.75
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact
- Basis:
- mean
- Time point:
- other: 24and 72 hours
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.58
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- The Primary Irritation Score was 3.29. This is below the value of 5 required for classification as a skin irritant.
Any other information on results incl. tables
Erythema Scores
|
|
Rabbit Number |
|||||
|
1 |
2 |
3 |
4 |
5 |
6 |
|
Intact skin |
24 |
2 |
2 |
2 |
2 |
2 |
2 |
Intact skin |
72 |
2 |
1 |
1 |
2 |
1 |
2 |
Abraded skin |
24 |
2 |
2 |
2 |
2 |
2 |
2 |
Abraded skin |
72 |
2 |
1 |
1 |
2 |
1 |
2 |
Subtotal: 7.0
Edema Scores
|
|
Rabbit Number |
|||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
Intact skin |
24 |
1 |
2 |
2 |
2 |
1 |
2 |
Intact skin |
72 |
2 |
1 |
1 |
2 |
1 |
1 |
Abraded skin |
24 |
1 |
2 |
2 |
2 |
1 |
2 |
Abraded skin |
72 |
2 |
1 |
1 |
2 |
1 |
2 |
Subtotal: 6.15
Total: 13.15
Primary Irritation Score: 13.15 ÷ 4 = 3.29
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Tetrapropenyl succinic anhydride (TPSA) was tested for skin irritation in rabbits in a guideline protocol (US 16 CFR 1500.41). When applied to the clipped intact and abraded skin under occlusive wrappings for 24 hours, the substance was not irritating. The substance is not classified as an irritant according to Regulation EC No. 1272/2008.
- Executive summary:
The skin irritation potential of this substance was evaluated in rabbits. The skin of six rabbits was clipped over a wide area. One side was abraded; the other side remained intact. A 0.5 ml portion of the test material was administered to the abraded and intact skin of each animal. The treated sites were covered with a gauze patch and then covered by an impervious material wrapped snuggly around the trunks. After 24 hours the wrapping were removed. Each site was evaluated at 24 and 72 hours according to method of Draize. The calculated mean 24 -72 hour scores for erythema and edema for intact skin was 1.75 and 1.5, respectively; and the calculated mean 24 -72 hour scores for erythema and edema for abraded skin was 1.75 and 1.58, respectively. The irritation effects were not reversible by the final observation at 72 hours.
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