Registration Dossier
Registration Dossier
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EC number: 605-404-6 | CAS number: 16535-55-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 7 experimental animals, 3 control animals
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 7 experimental animals, 3 control animals
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The maximisation test was already available and therefore a LLNA test was considered unnecessary.
Test material
- Reference substance name:
- (2,4-dioxo-1,3-benzoxazin-7-yl) ethyl carbonate
- EC Number:
- 605-404-6
- Cas Number:
- 16535-55-0
- Molecular formula:
- C11 H9 N O6
- IUPAC Name:
- (2,4-dioxo-1,3-benzoxazin-7-yl) ethyl carbonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.1N NaOH
- Concentration / amount:
- 10% concentration intradermally injected,
50% concentration epidermally exposed - Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: 0.1N NaOH
- Concentration / amount:
- 50% concentration
- No. of animals per dose:
- 7
- Details on study design:
- Based on a test substance pretest, 0.1N NaOH was selected as the most suitable vehicle for V194024.
Test concentrations selected for the main study were based on the results of a preliminary study using four animals. In the main study, seven animals were intradermally injected with a 10% concentration and epidermally exposed to a 50% concentration, while three control animals were similarly treated, but with 0.1 N NaOH only. Since no signs of irritation were observed at the concentration selected for the epidermal induction, all animals were treated with 10% SDS approximately 24 hours before the epidermal induction.
Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and 0.1N NaOH. The challenge reactions were assessed 24 and 48 hours after bandage removal. - Challenge controls:
- 3 animals
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% concentration
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% concentration
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 N NaOH
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 N NaOH
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No evidence was obtained that V194024 caused skin hypersensitivity in the guinea pig. This result lead to a sensitisation rate of 0%, indicating that V194024 need not be regarded as a potential skin sensitiser.
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