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EC number: 295-298-4 | CAS number: 91995-38-9 A complex combination of hydrocarbons obtained as first runnings from the depentanizer column before hydrotreatment of the aromatic charges. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C6, predominantly pentanes and pentenes, and boiling in the range of approximately 25°C to 40°C (77°F to 104°F).
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 01/07/1994 - 01/25/1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report similar or equivalent to OECD 404. GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 86290-81-5
- Cas Number:
- 86290-81-5
- IUPAC Name:
- 86290-81-5
- Reference substance name:
- Unleaded gasoline
- IUPAC Name:
- Unleaded gasoline
- Test material form:
- other: low viscosity liquid hydrocarbon
- Details on test material:
- - Name of test material (as cited in study report): API 91-01 unleaded gasoline
- Physical state: clear pink liquid
- Storage condition of test material: stored at room temperature in a brown glass jar with a brown plastic screw top
- Name of test material (as cited in study report): API PS-6
- Physical state: clear yellow liquid
- Storage condition of test material: stored at room temperature in a metal canister with a blue plastic lid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry Inc. 4678 Bethesda Rd. Thompson Station, TN 37179
- Housing: Individually housed in wire mesh suspension cages
- Diet (e.g. ad libitum): Purina laboratory rabbit chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The application sites for each rabbit were observed and scored 1/2 - 1, 24, 48, and 72 hours and at 7 and 14 days after removal of the patches.
- Number of animals:
- A total of four groups of six rabbits (three males and three females per group) were used in this study. The group were divided into two groups per test material, each test material having a semi-occluded group and an occluded group.
- Details on study design:
- TEST SITE
- Type of wrap if used: Two Webril pads, which were removed from the adhesive, and placed on top of each other. The pads were held in place by adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped free of residual test material by a gentle sponging using a paper towel moistened with tap water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- ca. 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- ca. 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- ca. 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01; 3/6 - edges of site appeared coriaceus
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: Day 7
- Score:
- ca. 0.83
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01; 6/6 - desquamation on site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 24/48/72 h average
- Time point:
- other: 24/48/72
- Score:
- ca. 2.56
- Max. score:
- 2.67
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- ca. 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: Day 7
- Score:
- ca. 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 24/48/72 h average
- Time point:
- other: 24/48/72
- Score:
- ca. 1.89
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API 91-01
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24 hr
- Score:
- ca. 2.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48 hr
- Score:
- ca. 2.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 72 hr
- Score:
- ca. 2.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: Day 7
- Score:
- ca. 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6; 5/6 - desquamation on site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 24/48/72 hr average
- Time point:
- other: 24/48/72
- Score:
- ca. 2.39
- Max. score:
- 2.5
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24 hr
- Score:
- ca. 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48 hr
- Score:
- ca. 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 72 hr
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: Day 7
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 24/48/72 h average
- Time point:
- other: 24/48/72
- Score:
- ca. 1.39
- Max. score:
- 1.67
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: API PS-6
- Other effects:
- In addition to the semi-occluded study, each test material was administered to a two groups of six rabbits via occlusive patches. Each animals received a 0.5 ml quantity of the appropriate undiluted test material onto a 1" x 1" guaze square. The patches were then held in place with adhesive tape. The test material was applied in this manner to one intact skin site per animal. After application of the patch, the trunk of each rabbit was wrapped with rubber dental dam which was secured with staples. An outer layer of gauze was then wrapped around the trunk of each animals and secured with tape. Following 4 hours of exposure, the patches were removed and the test sites were wiped free of residual test material in the same manner as the semi-occluded study. The erythema scores for API 91-01 at 24, 48, and 72 h were 2.67, 2.50, and 2.00, respectively. The edema scores at 24, 48, and 72h were 2.83, 2.33, and 2.00, respectively. The erythema scores for API PS-6 at 24, 48, and 72h were 2.33, 2.33, and 2.17, respectively. The edema scores at 24, 48, and 72h were 2.83, 2.33, and 2.17, respectively. The mean erythema and edema scores for API 91-01 were 2.39 and 2.39. The mean erythema and edema scores for API PS-6 were 2.28 and 2.44.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean erythema and edema scores for API 91-01 were 2.56 and 1.89, respectively. The mean erythema and edema score for API PS-6 were 2.39 and 1.39, respectively. This finding warrants classification of API 91-01 and API PS-6 as irritating under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) and as an R38 skin irritant under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Unleaded gasoline samples API 91-01 and API PS-6 were both administered via semi-occlusive patch for four hours to two groups of 6 New Zealand White rabbits (one group per test material) to assess dermal irritation. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and on Days 7, 10, and 14 according to the Draize method of scoring. Animals administered API 91-01 exhibited moderate to severe erythema (grade 3) at the 24h, 48h and 72h observation point. The erythema was fully reversible within 14 days. In the same group, maximum edema was noted in the 1st hour of observation and fluctuated with severity from slight (grade 2, 24 h) to very slight and no edema (grade 0/1, day 7); all animals were clear of edema by Day 14. Animals administered API PS-6 exhibited moderate erythema (grade 2) at the 24h, 48h, and 72 h observation point. The erythema was fullly reversible within 14 days. Maximum edema was observed 1h after removal of the patch and irritation due to edema subsided and was clear by Day 14 of the observation period. The mean erythema and edema scores for API 91-01 were 2.56 and 1.89, respectively. The mean erythema and edema score for API PS-6 were 2.39 and 1.39, respectively. This finding warrants classification of API 91-01 and API PS-6 as irritating under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) and as an R38 skin irritant under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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