Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 619-372-6 | CAS number: 98730-04-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)