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EC number: 619-372-6 | CAS number: 98730-04-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 February 1986 to 21 March 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- patch test
- Justification for non-LLNA method:
- The guinea pig miximisation test is the recommended adjuvant test for predictive sensitisation according to the above guidelines.
Test material
- Reference substance name:
- 2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one
- EC Number:
- 619-372-6
- Cas Number:
- 98730-04-2
- Molecular formula:
- C11H11Cl2NO2
- IUPAC Name:
- 2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Ten male Hartley-Albino Guinea Pigs
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 500 mg in 0.5 mL water
Challengeopen allclose all
- Route:
- other: Not applicable
- Vehicle:
- water
- Concentration / amount:
- 500 mg in 0.5 mL water
- No. of animals per dose:
- 10
- Details on study design:
- The sensitizing potential of test substance was assessed in a multiple insult patch sensitization test in Hartley-Albino Guinea Pigs. Each group of ten male Guinea Pigs were treated with 500 mg test substance, which was moistened with water, or with 0.5 ml of a 0.05% ethanolic solution of 2,4-dinitrochlorobenzene (DNCB), which served as a positive control. The test compounds were applied to the left, shaved flank of the animals, covered by a gauze pad (ca. 16x28mm) , which was held in place by an adhesive dressing, and the animals were placed in restrainers for approximately six hours. After this period the dressings were removed. Test material was applied on days 1, 3, 6, 8, 10, 13, 15, 17, 20 and 22. The skin reactions were scored according to the Draize scheme approximately 24 hours after every application and also 48 hours after the applications on days 1 and 22.
On day 36 the animals were challenged as described above on the left flank and on a previously untreated site on the right rump. Skin reactions were scored 24 and 48 hours after the challenge. - Challenge controls:
- Not applicable
- Positive control substance(s):
- yes
- Remarks:
- .05% ethanolic solution of 2,4-dinitrochlorobenzene (DNCB)
Results and discussion
- Positive control results:
- See Table.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 500 mg in 0.5 ml water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- dermal fissuring and eschar formation also observed at test sites
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 500 mg in 0.5 ml water. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: dermal fissuring and eschar formation also observed at test sites.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 500 mg in 0.5 ml water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- eschar formation observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 500 mg in 0.5 ml water. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: eschar formation observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5 ml DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- eschar formation observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 ml DNCB. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: eschar formation observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5 ml DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- eschar formation observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5 ml DNCB. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: eschar formation observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- All treated guinea pigs showed positive skin reactions to the test substance after challenge on day 36. No skin reactions were recorded 24 hours after the initial application of the test substance. It was concluded that the test substance was a potential skin sensitiser.
The reactions seen were similar to those in the positive control group, exposed to DNCB. - Executive summary:
The sensitising potential of the test substance was assessed in a multiple insult patch sensitization test in Hartley-Albino Guinea Pigs. Groups of of ten male guinea pigs were treated with 500 mg test substance, which was moistened with water, or with 0.5 mL of a 0.05% ethanolic solution of 2,4-dinitrochlorobenzene (DNCB), which served as a positive control. The test compounds were applied to the left, shaved flank of the animalson days 1, 3, 6, 8, 10, 13, 15, 17, 20 and 22. On day 36 the animals were challenged as described above on the left flank and on the previously untreated right rump. Skin reactions were scored 24 and 48 hours after the challenge.
All treated guinea pigs showed positive skin reactions to the test substance on the left flank and right rump after challenge on day 36. No skin reactions were recorded 24 hours after the initial application of benoxacor. It was concluded that the test substance was a potential skin sensitiser. The reactions seen were similar to those in the positive control group, exposed to DNCB.
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