Registration Dossier
Registration Dossier
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EC number: 620-448-6 | CAS number: 566200-79-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study suitable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Adjuvant and Patch test
- Principles of method if other than guideline:
- This maximisation test involves intradermal injection of FCA and abrasion of skin, application (topically) of the test material onto the abraded skin and then covering the test site with an occlusive patch. The topical challenge was made without a covering.
- GLP compliance:
- no
- Type of study:
- other: Adjuvant and Patch test
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: assumed to be ethanol (challenge control treatment)
- Concentration / amount:
- 1% S-DHMN used
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: assumed to be ethanol (challenge control treatment)
- Concentration / amount:
- 1% S-DHMN used
- No. of animals per dose:
- 10 in test group
- Challenge controls:
- 5
- Positive control substance(s):
- yes
- Remarks:
- 0.1% 2,4-dinitrochlorobenzene (DNCB)
Results and discussion
- Positive control results:
- Positive control results gave the expected results confirming that the conditions of this test were valid (see table 1 for positive control results).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Mean score 3.0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% challenge. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Mean score 3.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Mean score 2.8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1% challenge. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Mean score 2.8.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0.1% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Mean score 2.6
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 0.1% challenge. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Mean score 2.6.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, S-DHMN was not considered to be sensitising in female guinea pigs (Hartley strain).
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