Registration Dossier
Registration Dossier
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EC number: 951-779-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Human Repeat Insult Patch Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Human Repeat Insult Patch Test using generally-accepted methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed to confirm that repeated applications of the product under maximized conditions, in healthy subjetcs, does not induce delayed contact allergy reactions. A secondary objective is to determine the irritating potential of the product first after a single application and second after repeated applications.
- GLP compliance:
- no
- Remarks:
- study has been conducted in the spirit of the good Clinical Practice
- Type of study:
- patch test
- Justification for non-LLNA method:
- HRIPT study in human volunteers already available
Test material
- Reference substance name:
- Absolute of Nicotiana tabacum (Solanaceae) obtained from leaves by organic solvent treatment and subsequent ethanol extraction
- EC Number:
- 951-779-7
- Molecular formula:
- Not relevant, UVCB substance
- IUPAC Name:
- Absolute of Nicotiana tabacum (Solanaceae) obtained from leaves by organic solvent treatment and subsequent ethanol extraction
- Test material form:
- other: Semi-solid
- Details on test material:
- - Description: A dark brown, semi-solid mass
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Details on test animals and environmental conditions:
- - Number of subjects empanelled: 36 healthy inmate volunteers
- Number of subjects completed the study: 29 healthy inmate volunteers (4 dropped out, 2 transferred and one with SLS positive)
- Age: human 18+ yrs.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1% test item in petrolatum
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1% test item in petrolatum
- Details on study design:
- Maximization tests (Modified after JID 47393-409, 1966):
Test materials (1%) were applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only.
Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side.
Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Questionable reactions were followed on a daily basis for 1 week and retests were applied later at new sites. - Challenge controls:
- SLS controls were placed on the left and petrolatum on the right and labeled site 5.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1% test material presumably in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% test material presumably in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No evidence of irritation or sensitization were observed however with the other three materials applied. Therefore, the test item produced no reactions that were considered allergic or irritant in the twenty-nine subjects tested.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material can be considered as non-sensitizing at 1%.
- Executive summary:
In a Human Repeated Insult Patch Test, the primary irritation and sensitization properties of the test sample was tested on 29 volunteers. The test material (1%) was applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Questionable reactions were followed on a daily basis for 1 week and retests were applied later at new sites.
No evidence of skin irritation or sensitisation was observed in the 29 subjects tested.
Under the test conditions, the test material can be considered as non-sensitizing at 1%.
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