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Diss Factsheets
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EC number: - | 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 irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to valid methods and considered reliable, adequate and relevant, but it was non-GLP and only limited data were provided.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- fatty acids, C16-C18 and C18 unsaturated isopentyl esters, epoxidized
- IUPAC Name:
- fatty acids, C16-C18 and C18 unsaturated isopentyl esters, epoxidized
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): PLS Green 5; Plastificante A; soiato de isopentila epoxidado- ésteres isopentilicos de ácidos graxos (óleo de soja) epoxidados
- Substance type: Organic UVCB
- Physical state: liquid
- Lot/batch No.:2010-02; No.CPS: 145/2010
- Expiration date of the lot/batch: Shelf life: 2 years
- Other: Production site: Mogi das Cruzes, São Paulo
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: male young healthy adults
- Acclimation period: at least 5 days
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: . The areas not tested on the animal itself, serve as a control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The readings of the skin reactions are carried out in periods of 1, 24, 48, 72 hours and 14 days, as applicable.
- Number of animals:
- preliminary test: 1
main test: 2 - Details on study design:
- TEST SITE
- Area of exposure: dorsal thoracic region in an area of approximately 6 cm2
- Type of wrap if used:This area is covered with sterile gauze and secured with the help of hypoallergenic adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period (4 hours), residual test substance is removed using water or appropriate solvent, as necessary.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Evaluation of Edema formation:
Grade 0: No edema
Grade 1: Very light edema (little perceptive)
Grade 2: Mild edema (border area well-defined and more perceptive)
Grade 3: Moderate edema (increase of approximately 1 mm)
Grade 4: Severe edema (of more than 1 mm increase, including the area higher than the area in contact with the product)
Evaluation of Erythema formation:
Grade 0: Normal skin (usually white in color, can be pink)
Grade 1: Mild erythema (slightly reddened skin where realizes a tint unlike the control area)
Grade 2: Well-defined erythema (the skin becomes red, usually in every area)
Grade 3: Moderate to severe erythema (the skin presents with intense and diffuse redness)
Grade 4: Severe erythema of the skin (the skin presents mild eschar formation -injuries in depth)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- "PLS Green 5" (pH = 5.0) was held in the shaved region on the thoracic back of test animals (pre-test). After exposure of the test substance to the skin of the animal for a period of four hours, slight erythema (grade 1) was observed. However, after 24 hours after the start of the test, the skin presents with normal appearance and coloration featuring the complete reversibility of the observed reactions (grade 0). We also point out that the animal not presented any systemic signs of toxicity during the days of observation. The same pattern of skin reaction was observed in both animals used for the main test and there is also full reversibility of initial erythema observed. Since there were not detected any skin reactions for a period of 72 hours after removal of the semi-occlusive bandages, the test was terminated and the test substance classified as non-irritating.
Any other information on results incl. tables
Table 1- Values attributed to skin reactions after exposure of the animal to "PLS Green 5" in the pretest.
Cage |
Animal |
Parameters |
4h exposure |
1h |
24h |
48h |
72h |
14d |
1 |
1 |
Edema |
0 |
0 |
0 |
0 |
0 |
- |
|
|
Erythema |
1 |
0 |
0 |
0 |
0 |
- |
Table 2- Values attributed to skin reactions after exposure of the animal to "PLS Green 5" in the main test.
Cage |
Animal |
Parameters |
1h |
24h |
48h |
72h |
14d |
2 |
2 |
Edema |
0 |
0 |
0 |
0 |
- |
|
|
Erythema |
0 |
0 |
0 |
0 |
- |
Table 3- Values attributed to skin reactions after exposure of the animal to "PLS Green 5" in the main test.
Cage |
Animal |
Parameters |
1h |
24h |
48h |
72h |
14d |
3 |
3 |
Edema |
0 |
0 |
0 |
0 |
- |
|
|
Erythema |
0 |
0 |
0 |
0 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- "PLS Green 5" was not irritating to rabbit skin under the conditions of this test.
- Executive summary:
PLS Green 5 (Ph = 5.0) was administered in three New Zealand rabbits for 4h on 6 cm2 skin surface by semi-occlusive exposure. Scoring was done after 1h, 24h, 48h, 72h and 14 days for edema and erythema. Values for edema and erythema were 0 in all three annimals up to 72h. In conclusion, PLS Green 5 was not irritating.
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