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Registration Dossier
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EC number: 931-285-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report similar or equivalent to OECD 406 performed under GLP conditions on an analogue substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler skin sensitisation test is a scientifically valid method for assessing skin sensitisation potential. As the data exists and is adequate for hazard assessment, performing a new LLNA test is not scientifically justified
Test material
- Reference substance name:
- Naphtha (petroleum), light catalytic cracked
- EC Number:
- 265-056-2
- EC Name:
- Naphtha (petroleum), light catalytic cracked
- Cas Number:
- 64741-55-5
- IUPAC Name:
- Naphtha (petroleum), light catalytic cracked
- Reference substance name:
- Light catalytic cracked naphtha
- IUPAC Name:
- Light catalytic cracked naphtha
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction dose: 0.4 ml, neat
Challenge dose: 0.4 ml, 1:4 dilution in paraffin oil
Positive Control DNCB:
Induction dose: 0.4 ml, 0.3% dilution in 80% aq. ethanol
Challenge dose: 0.1% dilution in acetone
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction dose: 0.4 ml, neat
Challenge dose: 0.4 ml, 1:4 dilution in paraffin oil
Positive Control DNCB:
Induction dose: 0.4 ml, 0.3% dilution in 80% aq. ethanol
Challenge dose: 0.1% dilution in acetone
- No. of animals per dose:
- 4 males for dose-selection
10 males for induction/challenge
10 males for challenge control
10 males for vehicle control group
20 males for positive control group - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Frequency of applications: once per week
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 14 post-induction application
- Exposure period: 6 hours
- Evaluation (hr after challenge): 24 and 48 hrs
OTHER: response grade score = erythema + edema - Challenge controls:
- Naive guinea pigs receiving only the challenge dose in order to distinguish between “background” irritation response and actual allergenic response.
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
- Positive control results:
- DNCB:
Challenge: 24/48 hr average: 2.2 (response grade), 20/20 animals
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Challenge: Avg 24 and 48 hour readings
- Group:
- test chemical
- Dose level:
- 25% v/v dilution challenge phase
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 0.0 Erythema
0.0 Edema - Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Sensitizing Phase: Avg 24 and 48 hour readings
- Group:
- test chemical
- Dose level:
- 100% (applied neat)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 1.8 Erythema Avg
1.4 Edema Avg - Remarks on result:
- other: mild irritation
- Key result
- Reading:
- other: Challenge: Avg 24 and 48 hour readings
- Group:
- positive control
- Dose level:
- 2,4-dinitrochlorobenzene, was administered at a concentration of 0.3% w/v in 80% aqueous ethanol, wit. a dosage volume of 0.4 mL for the sensitizing phase.
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- 1.6 Erythema
0.75 Edema - Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: Sensitizing Phase: Avg 24 and 48 hour readings
- Group:
- positive control
- Dose level:
- 2,4-dinitrochlorobenzene, was administered at a concentration of 0.3% w/v in 80% aqueous ethanol, wit. a dosage volume of 0.4 mL for the sensitizing phase.
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- 2.25 Erythema
1.9 Edema - Remarks on result:
- other: Moderate Irritation
- Reading:
- other: Challenge: Avg 24 and 48 hour readings
- Group:
- negative control
- Dose level:
- 0.4% Paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 0.0 Erythema
0.0 Edema - Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Sensitizing Phase: Avg 24 and 48 hour readings
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0.4% Paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 0.0 Erythema
0.0 Edema - Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Light catalytic cracked naphtha (API 83-20) did not induce a sensitisation response in guinea pigs in this study. This finding does not warrant the classification of the test article as a skin sensitiser under the new 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:
Male Hartley Albino guinea pigs were dermally exposed to light catalytic cracked naphtha (API 83-20), neat, at a volume of 0.4 ml for each of the three induction phases. For the challenge phase, light catalytic cracked naphtha was administered as a 1:4 dilution in paraffin oil for the challenge and challenge control group animals. Response grades, severity and incidence at the time of the challenge exposure for the test article indicated no dermal responsiveness in the induction/challenge group above that observed in the naive challenge control group. 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. This finding does not warrant the classification of light catalytic cracked naphtha (API 83-20) as a skin sensitiser under the new 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.
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