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EC number: 265-111-0 | CAS number: 64742-11-6 A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
- 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

Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985-01-14 to 1985-02-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because the test compound was applied three times a week (a total of 12 times) instead of the recommended 5 times a week.
- 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:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- Compound was administered 3 times a week.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 64742-05-8
- IUPAC Name:
- 64742-05-8
- Reference substance name:
- Light paraffinic distillate solvent extract
- IUPAC Name:
- Light paraffinic distillate solvent extract
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Light paraffinic distillate solvent extract (petroleum), API 83-16
- Substance type: C15 to C30 hydrocarbon
- Physical state: Liquid, clear brownish
- Lot/batch No.:F000-6837
- Storage condition of test material: Room temperature in the original container
- Viscosity, SSU: 67.2 at 100°F
- API Gravity: 16.7
- Flash Point: (°F) 335
- Pour Point (°F): 20
- Aniline Point (°F): 95.5
- Sulfur, Wt %: 2.64
- Composition of test material ASTM D-2007, Wt. %:
Saturates: 29.2
Aromatics 68.6
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland, Denver, Pennsylvania
- Age at study initiation: young adult
- Weight at study initiation: males: 2.6 to 3.3 kilograms; females: 2.1 to 3.4 kilograms
- Housing: individually in stainless steel cages with grid bottoms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26
- Humidity (%): 18% to 40%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From: 1985-01-14 To: 1985-02-15
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: dorsal trunk
- % coverage: approximately 10%
- Type of wrap if used: sheet of polyurethane secured with Blenderm
- Time intervals for shavings or clippings: 24 hours prior to first dose, then as necessary
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with a dry clean gauze pad
- Time after start of exposure: 6 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0, 250, 500, or 1000 mg/kg/day
- Constant volume or concentration used: no
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 3 times a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500, or 1000 mg/kg/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- Five animals per sex per dose
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: based on a 5-day pilot study
- Rationale for animal assignment (if not random): random - Positive control:
- None reported
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day
- Cage side observations checked for mortality and morbidity.
DETAILED CLINICAL OBSERVATIONS: No
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily
BODY WEIGHT: Yes
- Time schedule for examinations: study initiation, weekly, and at study termination
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day:No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: study termination
- Anaesthetic used for blood collection: No
- Animals fasted: No data
- How many animals: all animals
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: study termination
- Animals fasted: No data
- How many animals: all animals
- Parameters checked in table 2 were examined.
URINALYSIS: No
- Time schedule for collection of urine: Urine was collected at study termination from control and high-dose animals and frozen for possible analysis.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (see table 3) - Other examinations:
- Organs noted in table 3 were weighed.
- Statistics:
- Two-tailed Student's t-test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- 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: Dermal irritation was the only clinical sign related to treatment. Erythema and oedema were observed at the application site in all treated groups, with increasing frequency and severity as the dose level increased. Minimal skin irritation (0.9 in males and 1.0 in females) at 250 mg/kg and moderate irritation at 500 (2.3 in males and 2.2 in females) and 1000 mg/kg (2.9 in males and 3.4 in females) was noted for both males and females. Flaking and/or cracked skin areas and leathery skin texture were observed and considered to be treatment related. Dry, scaly, rough, crusted, red and/or fissured skin and thickened dermis were observed.
BODY WEIGHT AND WEIGHT GAIN: One high-dose male lost weight over the study duration, which caused a statistically significant decrease in mean body weight. However, body weight gains in the remaining high-dose males were similar to the control males. There was no treatment-related changes in body weight observed in the females.
HAEMATOLOGY: No treatment-related effects were observed.
CLINICAL CHEMISTRY: No treatment-related effects were observed.
ORGAN WEIGHTS: Changes in organ weights considered to be treatment-related included an increase in the liver weights in high-dose males. All other changes were within normal ranges or there was no dose-response relationship.
GROSS PATHOLOGY: Gross pathological findings related to treatment were only found in the skin.
HISTOPATHOLOGY: Microscopic findings of slight to moderately proliferative changes were observed in the treated skin of all of the male and female rabbits at the 1000 mg/kg dose level. The testes of one of the five males at 1000 mg/kg had bilateral diffuse tubular hypoplasia accompanied by aspermatogenesis and a hyploplasia of the accessory sex organs. These findings were not observed in other animals, and hence considered to represent immature testes and hence not treatment-related.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: lack of systemic toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: dermal irritation
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on skin irritation, a NOAEL of 500 mg/kg can be established. The NOAEL for effects on tissues other than skin would be > 1000 mg/kg, the highest dose tested.
- Executive summary:
Light paraffinic distillate solvent extract (CAS# 64742 -05 -8) was tested in a subacute dermal exposure study. The undiluted test substance was applied to the shaved intact skin of 5 male and 5 female New Zealand White rabbits 3 times a week, on alternate days (occluded, 6 hours) for a total of 12 applications over a period of 28 days. Doses were 0, 250, 500, and 1000 mg/kg/application; these doses were chosen based on results from a five-day pilot study.
Erythema and oedema were observed at the application site in all treated groups, with increasing frequency and severity as the dose level increased. Minimal skin irritation at 250 mg/kg and moderate irritation at 500 and 1000 mg/kg was noted for both males and females. Flaking and/or cracked skin areas and leathery skin texture were observed and considered to be treatment related. Dry, scaly, rough, crusted, red and/or fissured skin and thickened dermis were observed. No statistical differences or noteworthy trends were seen in haematological and clinical chemistry.
Organ weight changes generally were either within the normal range or showed no dose-response relationship. However significantly elevated liver weights were observed for the high-dose males, which suggests a treatment-related finding. The authors concluded this finding not to be adverse based on histopathology analysis.
Microscopic findings of slight to moderately proliferative changes were observed in the treated skin of all of the male and female rabbits at the 1000 mg/kg dose level. The testes of one of the five males at 1000 mg/kg had bilateral diffuse tubular hypoplasia accompanied by aspermatogenesis and a hyploplasia of the accessory sex organs. These findings were not observed in other animals, and hence considered to represent immature testes and hence not treatment-related. No other relevant histopathological changes were observed. The authors concluded the test material had a significant effect only on dermal tissues under the conditions of this study. Based on skin irritation, a NOAEL of 500 mg/kg can be established. The NOAEL for effects on tissues other than skin would be >1000 mg/kg, the highest dose tested.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because the test compound was applied three times a week (a total of 12 times) instead of the recommended 5 times a week.
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