Registration Dossier
Registration Dossier
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EC number: 259-563-8 | CAS number: 55281-26-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- The category approach can be explained on the basis that all the category members are structurally similar disperse dyes and mono-azo halogen compounds presenting chlorine or bromine atom(s) which have similar physicochemical properties, particularly regarding their poor water soluble or not soluble behaviour. Five source substances can be considered part of the category: ID239 - Disperse Yellow UZ 3217-A (EC 400-090-5), ID248 - Disperse Red FC 38583 (EC 407-310-9), ID255 - Disperse Red CLA 282 (EC 416-240-8), ID257 - Disperse Red 378 (EC 424-290-7) and ID259 - Marine Cla 926 (EC 430-500-8).
These compounds have qualitatively similar effects and properties, but slight quantitative differences in water solubility values are present: a regular pattern variation of this physicochemical property can be identified within the category and related to the experimental results of each source substance.
Therefore, the prediction of eye irritating effects for the category members target substances ID346 - Disperse Blue 79 (EC 222-813-1), ID347 - Disperse Orange 30 (EC 226-070-4), ID348 - Disperse Orange 44 (EC 223-765-4), ID349 - Disperse Orange 61 (EC 259-563-8), ID350 - Disperse Yellow 211 (EC 274-660-5), ID370 - Disperse Blue 291 (EC 257-486-4) and ID371 - Disperse Violet 93:1 (EC 258-110-1) is based on the identified pattern according to the Scenario number 4 of RAAF (Read-Across Assessment Framework) [1]: different compounds have qualitatively similar properties.
Data source
Materials and methods
Test material
- Reference substance name:
- 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile
- EC Number:
- 259-563-8
- EC Name:
- 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile
- Cas Number:
- 55281-26-0
- Molecular formula:
- C17H15Br2N5O2
- IUPAC Name:
- 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile
Constituent 1
Results and discussion
In vivo
Results
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the information reported above it is possible to assert that the substance is not irritant to the eye.
- Executive summary:
On the basis of a robust and reliable category approach based on the source substances Disperse Yellow UZ 3217-A (EC 400-090-5), Disperse Red FC 38583 (EC 407-310-9), Disperse Red CLA 282 (EC 416-240-8), Disperse Red 378 (EC 424-290-7) and Marine Cla 926 (EC 430-500-8) and relying on the available data and information reported it is possible to assert that the target Disperse Orange 61 (EC 259-563-8) is not an eye irritant.
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.
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