Registration Dossier
Registration Dossier
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EC number: 664-495-0 | CAS number: 740817-98-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HRIPT(Human Repeat Insult Patch Testing)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Use repetitive epidermal contact to determine the potential of the title compound to induce primary or cumulative irritation and/or allergic contact sensitization.
- GLP compliance:
- no
- Type of study:
- patch test
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml of the test material (SugaNate 160)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml of the test material (SugaNate 160)
- No. of animals per dose:
- 6
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 x week 9 aplications (10% SugaNate) 0.5ml path
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 0.0. Total no. in groups: 6.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3 x week 9 aplications (10% SugaNate) 0.5ml path
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Clinical observations:
- barely perceptible or spotty erithema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: barely perceptible or spotty erithema.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, test material Suga®Nate 160, lot # 19518D08, did not indicate a potential for dermal irritation or allergic contact sensitization.
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