Registration Dossier
Registration Dossier
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EC number: 250-001-7 | CAS number: 30007-47-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
- Principles of method if other than guideline:
- Method: Wahlberg, J. E., Boman, A., Guinea Pig Maxirnization Test, in: K. E. Andersen, H. I. Maibach (eds.), Contact Allergy Predictive Tests in Guinea Pig, p. 59-106. S. Karger, Basel (1985)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted due to non-REACH regulatory requirements. With the existing data from this study this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
Test material
- Reference substance name:
- 5-bromo-5-nitro-1,3-dioxane
- EC Number:
- 250-001-7
- EC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Cas Number:
- 30007-47-7
- Molecular formula:
- C4H6BrNO4
- IUPAC Name:
- 5-bromo-5-nitro-1,3-dioxane
Constituent 1
- Specific details on test material used for the study:
- 10% in w/v Propylenglycol
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 400 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Intradermal: propylene glycol; Topical: ethanol
- Concentration / amount:
- 0.25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Intradermal: propylene glycol; Topical: ethanol
- Concentration / amount:
- 0.25%
- No. of animals per dose:
- 24
- Details on study design:
- RANGE FINDING TESTS: The topical irritancy of the substances used for induction and challenge was studied by means of a 48-h closed patch test in 4-8 animals. On each animal the compound was applied on three patches on the flank: one near the back, one near the abdomen, and one in the middle.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal and Epicutaneous)
- Exposure period: The testing was performed one week after pretreatment with Freund's complete adjuvant
- Test groups: 24 animals
- Control group: 12 animals
- Concentrations: For intradermal sensitization the test substance was diluted with propylene glycol at 0.25 % w/v a. i. For topical sensitization, 200 μL in ethanol 99.5 % at 0.50 % w/v a. i. was used.
B. CHALLENGE EXPOSURE
- Concentrations: Test substance was tested in ethanol 99.5 % at 0.25 % w/v a. i.
- Evaluation (hr after challenge): 24 h after removal of the patches with unknown criteria and grading
C. Rechallenge
Animals were rechallenged ethanol solutions of equimolar concentrations (0.012 mol/L) of test substance at 0.25 % w/v a. i.
On each patch 30 μL of the test solution was applied. - Challenge controls:
- Control group: Control animals only exposed to the suspected sensitizer at challenge.
Vehicle group: Test animals receiving the suspected sensitizer during sensitization but the vehicle alone at challenge. - Positive control substance(s):
- yes
- Remarks:
- 2-methylol phenol
Results and discussion
- Positive control results:
- Positive control animals sensitized to and challenged with the known sensitizer 2-methylol phenol showed the expected results.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Group:
- other: control group
- Dose level:
- 0.25%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.25%
- No. with + reactions:
- 19
- Total no. in group:
- 24
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0.25%
- No. with + reactions:
- 4
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 0.25%
- No. with + reactions:
- 18
- Total no. in group:
- 24
- Key result
- Reading:
- rechallenge
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 12
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
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