Registration Dossier
Registration Dossier
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EC number: 270-796-4 | CAS number: 68478-17-1 A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
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:
- 1979-11-10 to 1979-12-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Near-guideline, GLP-compliant study. Adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
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: API procedure (see Reference).
- 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:
- 68553-00-4
- Cas Number:
- 68553-00-4
- IUPAC Name:
- 68553-00-4
- Reference substance name:
- No 6 Fuel Oil
- IUPAC Name:
- No 6 Fuel Oil
- Test material form:
- other: viscous hydrocarbon liquid
- Details on test material:
- No. 6 Heavy Fuel Oil (API 78-8 with Specific Gravity 0.99/2.7%S),Fuel oil No. 6, CAS No. 68553-00-4.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Camm Research Institute (Wayne, NJ)
- Age at study initiation: Young adult
- Housing: in stainless steel cages with indirect bedding
- Diet (e.g. ad libitum): Purina guinea pig chow ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: 11 days
IN-LIFE DATES: From: 29-10-1979 To: 15-12-1979
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: Not conducted since irritation tests in rabbits produced only minimal irritation
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9 (3 times a week for 3 weeks)
- Exposure period: 6 hours
- Test groups: 1
- Site: shaved area (3" x 3"), depilatated with Neet on back
- Frequency of applications: 3 times a week for 3 weeks
- Duration: 3 weeks
- Concentrations: 0.5 mL (unchanged)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks post induction
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: left side of back
- Concentrations: 0.5 mL
- Evaluation (hr after challenge): 24 hours - Positive control substance(s):
- yes
- Remarks:
- 0.05% (w/v) chlorodinitrobenzene in absolute ethanol
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Mean Erythema score of 10 readings
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Mean erythema score was 0.22
- Remarks on result:
- other: Reading: other: Mean Erythema score of 10 readings. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score was 0.22.
- Reading:
- other: Mean erythema score at challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Mean erytema score at challenge was 0.900
- Remarks on result:
- other: Reading: other: Mean erythema score at challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Mean erytema score at challenge was 0.900.
- Reading:
- other: Mean edema score of 1o readings
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Mean edema score was 0.010
- Remarks on result:
- other: Reading: other: Mean edema score of 1o readings. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Mean edema score was 0.010.
- Reading:
- other: Mean edema score at challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Mean edema score at challenge was 0.200
- Remarks on result:
- other: Reading: other: Mean edema score at challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Mean edema score at challenge was 0.200.
- Reading:
- other: Mean erythema score of 5 readings
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05 % (w/v)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Mean erythema score was 1.0889
- Remarks on result:
- other: Reading: other: Mean erythema score of 5 readings. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05 % (w/v). No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score was 1.0889.
- Reading:
- other: Mean erythema score at challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% (w/v)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Mean erythema score at challenge was 1.6667
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Mean erythema score at challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% (w/v). No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score at challenge was 1.6667.
- Reading:
- other: Mean edema score of 5 readings
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% (w/v)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Mean edema score was 0.0667
- Remarks on result:
- other: Reading: other: Mean edema score of 5 readings. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% (w/v). No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Mean edema score was 0.0667.
- Reading:
- other: Mean edema score at challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% (w/v)
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Mean edema score at challenge was 0.5556
- Remarks on result:
- other: Reading: other: Mean edema score at challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% (w/v). No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: Mean edema score at challenge was 0.5556.
Any other information on results incl. tables
A statistically significant difference between sensitizing and challenge treatments for erythema and oedema was noted among the test animals, but the challenge scores were less than the sensitizing average, indicating that the test substance was non-sensitizing.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Results of a closed patch skin sensitisation study in guinea pigs indicate that the material was not a skin sensitiser.
- Executive summary:
Skin sensitising potential was investigated in guinea pigs using a closed patch test procedure. Ten adult male albino guinea pigs were each treated with 0.5 mL of the test material, three times per week for three weeks. The patches were left in place for 6 hours before removal. Two weeks after final application, they were challenged with 0.5 mL of test material. Scores were taken at 24 hours according to the Draize scale. A naive control group of 10 animals and a positive control group of 10 animals were also included. The naive control group was treated with test substance in the challenge phase only. The positive control group was treated with a 0.05% (w/v) dilution of dinitrochlorobenzene in both the sensitizing and challenge phases.
A statistically significant difference between sensitizing and challenge treatments for erythema and edema was noted among the test animals, but the challenge scores were less than the sensitizing average, indicating that the test substance was non-sensitizing.
Based on results of the dermal challenge procedure the material was not considered to be a skin sensitiser.
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