Registration Dossier
Registration Dossier
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EC number: 202-770-5 | CAS number: 99-59-2
Endpoint summary
Administrative data
Description of key information
The substance 5-nitro-o-anisidine was found to be moderatelly irritating to the human skin and irritating to the human eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: other guideline:;OECD Guideline 404 (Acute dermal irritation / corrosion)
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 2.3.
- GLP compliance:
- no
- Species:
- other: rabbit;human
- Type of coverage:
- other: semiocclusive;occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 3.2
- Reversibility:
- no data
- Remarks on result:
- other: moderately irritating
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- By primary dermal irritation index (PDII) from QSAR, skin irritation score of 5-nitro-o-anisidine was estimated as 3.2. Based on this score 5-nitro-o-anisidine was found to be moderately irritating to the human skin.
- Executive summary:
By primary dermal irritation index (PDII) from QSAR, skin irritation score of 5-nitro-o-anisidine was estimated as 3.2. Based on this score 5-nitro-o-anisidine was found to be moderately irritating to the human skin.
Reference
The prediction was based on dataset comprised from the following descriptors: "Primary Irritation Index"
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(("a" and "b" ) and ("c" and "d" ) )
Domain logical expression index: "a"
Similarity boundary:Target: c1(OC)c(N)cc(N(=O)=O)cc1
Threshold=50%,
Dice(Atom pairs)
Domain logical expression index: "b"
Similarity boundary:Target: c1(OC)c(N)cc(N(=O)=O)cc1
Threshold=60%,
Dice(Atom pairs)
Domain logical expression index: "c"
Parametric boundary:The target chemical should have a value of log Kow which is >= 0.684
Domain logical expression index: "d"
Parametric boundary:The target chemical should have a value of log Kow which is <= 2.46
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from dose.
- GLP compliance:
- not specified
- Species:
- other: unspecified
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- other: irritating
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the DOSE, the substance 2-nitro-p-anisidine exhibit irritating effect.
- Executive summary:
According to the DOSE, the substance 2 -nitro-p-anisidine exhibit irritating effect.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation:-
By primary dermal irritation index (PDII) from QSAR, skin irritation score of 5-nitro-o-anisidine was estimated as 3.2. Based on this score 5-nitro-o-anisidine was found to be moderately irritating to the human skin.
Eye irritation:-
According to the DOSE, the substance 5-nitro-o-anisidine exhibit irritating effect.
Justification for selection of skin irritation / corrosion endpoint:
By primary dermal irritation index (PDII) from QSAR, skin irritation score of 5-nitro-o-anisidine was estimated as 3.2. Based on this score 5-nitro-o-anisidine was found to be moderately irritating to the human skin.
Justification for selection of eye irritation endpoint:
According to the DOSE, the substance 5-nitro-o-anisidine exhibit irritating effect.
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
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.
