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EC number: 930-936-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report similar or equivalent to OECD 406. GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- Mono-, and di-(sec-hexadecyl)naphthalene
- EC Number:
- 930-936-3
- Molecular formula:
- C26H40 + C42H72
- IUPAC Name:
- Mono-, and di-(sec-hexadecyl)naphthalene
- Details on test material:
- - Name of test material (as cited in study report): MCP 917
- Physical state: pale yellow liquid
- Storage condition of test material: airtight metal can; stored in a ventilated cabinet at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Kingston, Kingston, NJ 12484
- Age at study initiation: ~ 1 month old
- Weight at study initiation: 326-416 g
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): standard pellet diet, ad libitum
- Acclimation period: at least 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-75
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Squibb mineral oil (SMO)
- Concentration / amount:
- 0.4 ml, 100% w/w in squibb mineral oil (SMO)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Squibb mineral oil (SMO)
- Concentration / amount:
- 0.4 ml, 75% w/w in squibb mineral oil (SMO)
- No. of animals per dose:
- Induction and Challenge: 20 guinea pigs
Challenge Control: 10 guinea pigs
Positive Control: 10 guinea pigs - Details on study design:
- RANGE FINDING TESTS: Four guinea pigs from a previous shipment were randomly treated with four concentrations of the study substance (100%, 75%, 50%, or 25% in SMO). In the evaluation of the irritation potential, the 100% concentration produced no significant dermal response. Therefore, the 100% concentration was chosen as a reasonable induction dose and as an exaggerated human exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test group: Induction group (20 animals)
- Site: Back
- Frequency of applications: once per week
- Duration: 3 weeks
- Concentrations: 0.4 ml, neat
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days post-induction
- Exposure period: 6 hrs
- Test groups: Induction group (20 animals)
- Control group: Naive group (10 animals)
- Site: back
- Concentrations: 0.4 ml, 75% in SMO
- Evaluation (hr after challenge): 24 hours with additional depilation and 48 hours without additional depilation - Challenge controls:
- a naive control group
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
- Positive control results:
- The 0.05% w/v concentration of DNCB in acetone has been determined to be the highest non-irritating concentration for challenge. No skin irritation was observed during the induction phase. During the challenge phase, the positive control animals were considered to have been sensitized, based on the test criterion of a minimum of "+2" response for positively-responding animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% w/w in SMO
- No. with + reactions:
- 5
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: test group. Dose level: 75% w/w in SMO. No with. + reactions: 5.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% w/w in SMO
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. Hours after challenge: 48.0. Group: test group. Dose level: 75% w/w in SMO. No with. + reactions: 3.0. Total no. in groups: 19.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% w/w in SMO
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: Control group. Dose level: 75% w/w in SMO. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75% w/w in SMO
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. Hours after challenge: 48.0. Group: control group. Dose level: 75% w/w in SMO. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% w/w DNCB in acetone
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Positive control study conducted by testing facility demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitisers.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05% w/w DNCB in acetone
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Positive control study conducted by testing facility demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitisers.
Any other information on results incl. tables
At the 24 hour time point, 5 of 19 animals exposed to the study substance showed positive responses graded as 1 but at the 48 hour time point, 3 of 19 animals. Grade 1 responses were also observed in 2 of 10 naive challenge control animals at the 24 hour time point and 4 of 10 animals at the 48 hour time point. Because the responses were not more severe in the study substance exposed animals than in control animals, these were not considered positive responses. By comparison, 5 of 5 positive control animals exposed to DNCB had responses graded as 2 or more.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the results at challenge, the study substance did not induce a sensitisation response in guinea pigs in this study. This finding does not warrant the classification of the study substance 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:
Hartley Albino guinea pigs were dermally exposed to the study substance neat, 75% or 50% in Squibb mineral oil (SMO). For the challenge phase, the study substance concentration was 75% in SMO. Response grades, severity and incidence at the time of the challenge exposure for the study substance 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. The animals were clinically observed five days per week and no treatment-related changes were noted. Based on the results at challenge, the study substance did not induce a sensitisation response in guinea pigs in this study. This finding does not warrant the classification of the study substance 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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