Registration Dossier
Registration Dossier
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EC number: 297-852-0 | CAS number: 93763-33-8 A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
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:
- 1985/11/18 - 1986/01/03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report in agreement with OECD guideline 406-GLP.
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)
- Deviations:
- no
- 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:
- 86290-81-5
- Cas Number:
- 86290-81-5
- IUPAC Name:
- 86290-81-5
- Reference substance name:
- Premium unleaded gasoline
- IUPAC Name:
- Premium unleaded gasoline
- Test material form:
- other: low viscosity liquid hydrocarbon
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: CAMM Research Laboratory Animals, Wayne, NJ 07470
- Age at study initiation: young adults
- Weight at study initiation: 284-331g
- Housing: individually
- Diet (e.g. ad libitum): fresh Certified Purina guinea pig chow #5026, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days, induction phase animals; 7 days, dose selection phase animals
ENVIRONMENTAL CONDITIONS
-Temperature: 64 to 74 degrees F
-Humidity: 29 to 62 percent relative humidity
-Photoperiod: 12hrs dark/12hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 0.5 ml, neat
Challenge: 0.5 ml, neat
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 0.5 ml, neat
Challenge: 0.5 ml, neat
- No. of animals per dose:
- Dose selection: 6
Induction/challenge: 20
Challenge control: 8 - Details on study design:
-
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 (receiving 0.5 ml of undiluted test article)
- Control group: 2 (challenge control and positive control (0.3% DNCB in 80% ethanol/water))
- Site: along a side of the dorsal midline
- Frequency of applications: Weekly
- Duration: Three weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 14 post induction applications
- Exposure period: 6 hours
- Test groups: 1 (receiving 0.5 ml of undiluted test article)
- Control group:2 (Challenge control and positive control (0.2% DNCB in 80% ethanol/water))
- Site: Naive area along a side of the dorsal midline
- Evaluation (hr after challenge): 24- and 48-hours post-application, challenge sites were scored for erythema and edema according to the Draize technique - Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene (2,4 DNCB)
Results and discussion
- Positive control results:
- Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group.
DNCB:
Challenge: 24 h reading: 3.2 (response grade), 10/10 animals
48 h reading: 2.4 (response grade), 10/10 animals
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL neat
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- Avg. combined erythema/edema score = 2.0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL neat. No with. + reactions: 9.0. Total no. in groups: 9.0. Clinical observations: Avg. combined erythema/edema score = 2.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL neat
- No. with + reactions:
- 8
- Total no. in group:
- 9
- Clinical observations:
- Avg. combined erythema/edema score = 0.9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL neat. No with. + reactions: 8.0. Total no. in groups: 9.0. Clinical observations: Avg. combined erythema/edema score = 0.9.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Avg. combined erythema/edema score = 2.0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 0.5 mL. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Avg. combined erythema/edema score = 2.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Avg. combined erythema/edema score = 1.2
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0.5 mL. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Avg. combined erythema/edema score = 1.2.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test article F-64-01 was not a delayed contact sensitizer and the positive control DNCB was a delayed contact sensitizer.
- Executive summary:
Male Hartley Albino guinea pigs were dermally exposed to test article F-64-01 neat at a volume of 0.5 ml for each of three induction phases. For the challenge phase, the test article was administered undiluted for both the induction/challenge and challenge control group animals. Response grades, severity and incidence at the time of the challenge exposure for the test article F-64-01 indicated no dermal responsiveness in the induction/challenge group above that observed in the naive challenge control group. The naive challenge irritation control group animals were also free of any dermal response. Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group.
Under the conditions of the test, the test article F-64-01 was not a delayed contact sensitizer and the positive control DNCB was a delayed contact sensitizer.
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