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EC number: 265-098-1 | CAS number: 64741-97-5 A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19 cSt at 40°C). It contains relatively few normal paraffins.
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985-02-01 to 1985-08-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to or similar to OECD Guideline 406 without exceptions.
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 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Method: other
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.
Test material
- Reference substance name:
- 64742-53-6 (>3% IP346)
- IUPAC Name:
- 64742-53-6 (>3% IP346)
- Reference substance name:
- Hydrotreated light naphthenic oil, insufficiently refined, IP346>3%
- IUPAC Name:
- Hydrotreated light naphthenic oil, insufficiently refined, IP346>3%
- Test material form:
- other: Oily liquid
- Details on test material:
- Test substance: Insufficiently refined Base oil Sample API 83-12 [CAS# 64742-53-6]
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland, Inc.
- Age at study initiation: young adult (5 to 6 weeks)
- Weight at study initiation: 422 to 593 grams
- Housing: individually house in cages
- Diet (e.g. ad libitum): Purina Certified Guinea Pig Chow #5026 provided ad libitum
- Water (e.g. ad libitum): water provided ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24°C
- Humidity (%): 37 to 58%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 1984-02-01 To: 1985-02-28
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Paraffin oil
- Concentration / amount:
- Sensitising phase: 0.4 mL 50% v/v dilution in paraffin oil
Challenge phase: 0.4 mL 1% v/v dilution in paraffin oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Paraffin oil
- Concentration / amount:
- Sensitising phase: 0.4 mL 50% v/v dilution in paraffin oil
Challenge phase: 0.4 mL 1% v/v dilution in paraffin oil
- No. of animals per dose:
- 10 in treatment group, naive control group, and vehicle control group
20 in naive positive control group and positive control group - Details on study design:
- 1st application: Induction 50 % occlusive epicutaneous
2nd application: Challenge 1 % occlusive epicutaneous
RANGE FINDING TESTS: in a range-finding test an undiluted sample of test material was administered at concentration of 25, 50, and 75% v/v in paraffin oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: six hours
- Test groups: one treatment control group
- Control group: positive and vehicle control groups
- Site: backs of animals
- Frequency of applications: once a week
- Duration: three weeks
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: one
- Exposure period: six hours
- Test groups: one treatment group
- Control group: naive and vehicle control group; naive positive and positive control group
- Site: backs of animals
- Concentrations: 0.1%
- Evaluation (hr after challenge): 24 hours
- Challenge controls:
- naive control group dosed with 0.4 mL of 0.1% v/v mixture of test material in paraffin wax
vehicle control group dosed with 0.4 mL of undiluted paraffin oil
positive control group and naive positive control groups were dosed with 0.4 mL of a 0.1% v/v suspension of 2,4 dinitrochlorobenzene in acetone - Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene
Results and discussion
- Positive control results:
- In the positive control group, very slight to severe irritation was exhibited by all 20 animals. The reactions of 18 animals exceeded the highest reaction observed in the naive positive control animals.
In the naive positive control group three of the twenty animals exhibited very slight erythema reactions. The other 17 animals exhibited no reaction.
In vivo (non-LLNA)
Results
- Reading:
- other: average of two challenge readings
- Group:
- test chemical
- Dose level:
- 1% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- slight erythema reaction exhibited by one animal; not considered a significant sensitising response
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: average of two challenge readings. Group: test group. Dose level: 1% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: slight erythema reaction exhibited by one animal; not considered a significant sensitising response.
Any other information on results incl. tables
The
criteria used to evaluate the responses are described in the report
as
follows:
Determination of sensitization was based upon reactions to the challenge dose.
Grades of 1 or greater in the test animals indicate evidence of
sensitization,
provided grades of less than 1 are seen in the naive controls.
If grades of 1 or greater are noted in the naive control animals,
then the reactions of test animals that exceed the most severe
naive
control reaction are considered sensitization reactions.
One animal had a score of 0.5 after challenge with API 83-12. In contrast,
all the positive control animals were sensitized by their treatment.
The
sample of API 83-12 was therefore non sensitizing.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material is classified as not sensitising
- Executive summary:
In the induction phase of a skin sensitisation study, 0.4 mL of a 50% mixture of test material and paraffin oil was applied under an occlusive dressing to the shorn skin of 10 male and 10 female animals. Six hours after application, the dressings were removed and the skin wiped to remove residues of test material. The animals received one application each week for three weeks. The same application site was used each time. Two weeks following the third application, a challenge dose (0.4 ml of a 1% mixture in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. The application sites for induction and challenge doses were read for erythema and oedema 24 and 48 hours after patch removal. To assist in the reading of the response to the final challenge dose the test site was depilated three hours prior to reading by using a commercially available depilatory cream. 2,4-dinitrochlorobenzene at 0.3% in 80% aqueous ethanol at was used as the positive control in the induction phase and 2,4-dinitrochlorobenzene in acetone was used as the positive control in the challenge phase. Vehicle control and naive control groups were included in this study and the procedure for these was the same as for the test groups.
In the challenge phase, one animal in the treatment group exhibited a very slight erythema reaction. No animals exhibited reaction in the naive or vehicle control group. In the positive control group, 20 animals exhibited a very slight to severe irritation reaction. The reactions of 18 animals exceeded the highest reaction observed in the naive positive control animals. In the naive positive control group, three animals exhibited very slight erythema reactions. Based on these results, the test material is not considered to be a skin sensitizer under the conditions of this study.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to OECD Guideline 406.
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