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EC number: 265-079-8 | CAS number: 64741-78-2 A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12, and boiling in the range of approximately 65°C to 230°C (148°F to 446°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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report. GLP.
- Justification for type of information:
- Concawe believes that dermal is the most relevant exposure route, and is sufficiently robust, to identify any potential hazards from repeated exposures to petroleum products to be able to adequately manage the potentially associated risks. However, the primary objective of the testing required for REACH is the identification of hazard, for which the default exposure route under the regulation is oral as this is considered to maximise systemic exposure. To address the regulatory exposure route issue, Concawe will review the current data base for evidence of systemic toxicity after dermal exposure and will also conduct a number of oral OECD 422 studies on prioritized substances in each relevant petroleum category. The document attached provides a concise overview of the information to further support the dermal route of exposure and proposed additional work, as part of a larger testing strategy (the strategy document can be found in Annex 13).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- 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
- Reference substance name:
- API PS-6
- IUPAC Name:
- API PS-6
- Test material form:
- other: low viscosity liquid hydrocarbon
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Eppley Colony
- Age at study initiation: 5 weeks
- Housing: Each group in separate rooms
- Diet (e.g. ad libitum): Wayne Lab Blox Pellets ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- Lifetime of the mice
- Frequency of treatment:
- 3 times per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.05 ml
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 50 mice per dose
- Control animals:
- yes
- Details on study design:
- Negative control: 122 mice used
- Positive control:
- Positive control animals were treated according to the same protocol as test animals. Two positive control groups of 50 male mice were painted three times weekly with 0.05% and 0.15% BP, respectively. The designated doses were delivered in 0.05 ml aliquots to a shaved 1 square centimeter area of skin in the interscapular region.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 3 times per week
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: 3 times per week
BODY WEIGHT: Yes
- Time schedule for examinations: twice per month - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes. All applications sites were examined. All tumors and suspect lesions were diagnosed microscopically. All tumors and other pathological lesions were examined histologically. Sections of skin, lung, liver, kidney, urinary bladder, and other gross pathology were preserved in 10% phosphate buffered formalin, stained with hematoxylin and eosin, and examined microscopically. - Statistics:
- Where appropriate, statistical analyses using Fisher's Exact Test and the reference Biometrika Tables for Statisticians vol I (Cambridge Univ. Press, 1966, pp 73-80) were applied. In addition the Chi-square distribution was calculated according to Colton (Statistics in Medicine, Theodor Colton, Little, Brown and Co., Boston, 1974, pp 176-7, 348). For possible rare tumors designated in the text probabilities were also calculated using the Poisson distribution . Unless designated otherwise, the Chi-square calculation was applied.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: The mean survival of the four treated groups was 14/50 (28%) compared to 112/122 (92%) in the untreated control.
BODY WEIGHT AND WEIGHT GAIN: Decreased body weight gain was observed in the treated groups when compared to the untreated control.
GROSS PATHOLOGY: Multiple pathological disorders of kidney,lung, liver, lymph node, and spleen were observed in differing frequencies in treated groups compared with the untreated control.
HISTOPATHOLOGY: NON-NEOPLASTIC: Primarily inflammatory and degenerative lesions.
HISTOPATHOLOGY: NEOPLASTIC: There were few apparent neoplastic responses.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 0.5 other: ml
- Sex:
- male
- Basis for effect level:
- other: Chronic treatment with PS-6 did not significantly change the incidence of liver hemangiomas, lung adenomas, or of malignant lymphomas compared to negative and historical controls.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The incidence of skin carcinomas, liver hemangiomas, lung adenomas, and malignant lymphomas was no greater with the test substance than for the negative control group. Unleaded gasoline did not display chronic dermal toxicant propoerties in this study. This finding does not warrant the classification of unleaded gasoline as a chronic dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Unleaded gasoline was examined for its chronic dermal toxicity potential. Unleaded gasoline was administered via dermal application to the skin of 50 Swiss mice three times per week for two years. A negative control group was not treated while the two positive control groups were administered 0.05 ml of 0.05% BaP and 0.05 ml of 0.15% BaP in acetone. The test substance caused hyperkeratosis, fibrosis of the dermis, extoabscess and skin ulceration in the treatment areas. The incidence of skin carcinomas, liver hemangiomas, lung adenomas, and malignant lymphomas was no greater with the test substance than for the negative control group. Unleaded gasoline did not display chronic dermal toxicant properties in this study. This finding does not warrant the classification of unleaded gasoline as a chronic dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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