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EC number: 202-548-8 | CAS number: 96-97-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Control animals:
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 243.829 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- In Combined Repeated Dose Toxicity Study with the Reproduction Test NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in female rat by oral (gavage)route was estimated at a dose concentration of 243.8289 mg/kg bw/day.
- Executive summary:
In Combined Repeated Dose Toxicity Study with the Reproduction Test NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in female rat by oral (gavage)route was estimated at a dose concentration of 243.8289 mg/kg bw/day.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((((("a"
and ("b"
and (
not "c")
)
)
and ("d"
and (
not "e")
)
)
and "f" )
and "g" )
and "h" )
and ("i"
and "j" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Group 14 - Carbon C AND Group 15
- Nitrogen N AND Group 16 - Oxygen O by Chemical elements
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.1
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
acylation involving a leaving group OR Acylation >> Direct acylation
involving a leaving group >> Carbamates OR Acylation >> Direct acylation
involving a leaving group >> N-acylamides OR Acylation >> Ring opening
acylation OR Acylation >> Ring opening acylation >> Active cyclic agents
OR Michael addition OR Michael addition >> Michael addition on
conjugated systems with electron withdrawing group OR Michael addition
>> Michael addition on conjugated systems with electron withdrawing
group >> alpha,beta-carbonyl compounds with polarized double bonds OR
Michael addition >> Quinone type compounds OR Michael addition >>
Quinone type compounds >> Quinone (di)imines OR Schiff base formation OR
Schiff base formation >> Pyrazolones and pyrazolidinones derivatives OR
Schiff base formation >> Pyrazolones and pyrazolidinones derivatives >>
Pyrazolones and pyrazolidinones OR SN2 OR SN2 >> Nucleophilic
substitution at Nitrogen atom OR SN2 >> Nucleophilic substitution at
Nitrogen atom >> N-halogenated diketones or sulfoxides/sulfones OR SN2
>> Nucleophilic substitution on heterocyclic sulfenamides OR SN2 >>
Nucleophilic substitution on heterocyclic sulfenamides >> Heterocyclic
sulfenamides by Protein binding by OASIS v1.1
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OECD
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
Acylation Involving a Leaving group OR Acylation >> Direct Acylation
Involving a Leaving group >> Acetates by Protein binding by OECD
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as High (Class III) by Toxic hazard
classification by Cramer (original)
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis
Domain
logical expression index: "h"
Similarity
boundary:Target:
C(=O)(O)c1c(O)ccc(N(=O)=O)c1
Threshold=10%,
Dice(Atom centered fragments)
Domain
logical expression index: "i"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 2.14
Domain
logical expression index: "j"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 2.73
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 243.829 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The data is K2 level as the data has been obtained from QSAR model considered by OECD.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Toxicity to reproduction
In Combined Repeated Dose Toxicity Study with the Reproduction Test NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in female rat by oral (gavage)route was estimated at a dose concentration of 243.8289 mg/kg bw/day.
Short description of key information:
5-nitrosalicylic acid does not show any reperotoxic effects in rats.
Justification for selection of Effect on fertility via oral route:
In Combined Repeated Dose Toxicity Study with the Reproduction Test NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in female rat by oral (gavage)route was estimated at a dose concentration of 243.8289 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
5-nitrosalicylic acid does not show any developmental effects in rats.
Link to relevant study records
- Endpoint:
- developmental toxicity
- 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:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Control animals:
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 220.8 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- other: not specified
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- The fetotoxicity NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in rat by oral exposure was observed at a dose concentration of
220.8 mg/kg bw/day. - Executive summary:
The fetotoxicity NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in rat by oral exposure was observed at a dose concentration of 220.8 mg/kg bw/day
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((((("a"
and ("b"
and (
not "c")
)
)
and ("d"
and (
not "e")
)
)
and "f" )
and "g" )
and "h" )
and ("i"
and "j" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Group 14 - Carbon C AND Group 15
- Nitrogen N AND Group 16 - Oxygen O by Chemical elements
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.1
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
acylation involving a leaving group OR Acylation >> Direct acylation
involving a leaving group >> Carbamates OR Acylation >> Direct acylation
involving a leaving group >> N-acylamides OR Michael addition OR Michael
addition >> Michael addition on conjugated systems with electron
withdrawing group OR Michael addition >> Michael addition on conjugated
systems with electron withdrawing group >> alpha,beta-carbonyl compounds
with polarized double bonds OR Michael addition >> Michael addition on
conjugated systems with electron withdrawing group >> Cyanoalkenes OR
SN2 OR SN2 >> Interchange reaction with sulphur containing compounds OR
SN2 >> Interchange reaction with sulphur containing compounds >> Thiols
and disulfide compounds OR SN2 >> Nucleophilic substitution at Nitrogen
atom OR SN2 >> Nucleophilic substitution at Nitrogen atom >>
N-halogenated diketones or sulfoxides/sulfones OR SN2 >> Nucleophilic
substitution on heterocyclic sulfenamides OR SN2 >> Nucleophilic
substitution on heterocyclic sulfenamides >> Heterocyclic sulfenamides
OR SNAr OR SNAr >> Nucleophilic aromatic substitution on activated
halogens OR SNAr >> Nucleophilic aromatic substitution on activated
halogens >> Activated haloarenes by Protein binding by OASIS v1.1
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OECD
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
Acylation Involving a Leaving group OR Acylation >> Direct Acylation
Involving a Leaving group >> Acetates by Protein binding by OECD
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No superfragment by
Superfragments
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis
Domain
logical expression index: "h"
Similarity
boundary:Target:
C(=O)(O)c1c(O)ccc(N(=O)=O)c1
Threshold=20%,
Dice(Atom centered fragments)
Domain
logical expression index: "i"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 1.98
Domain
logical expression index: "j"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 2.67
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 220.8 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The data is K2 level as the data has been obtained from QSAR model considered by OECD.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Developmental toxicity / teratogenicity
The fetotoxicity NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in rat by oral exposure was observed at a dose concentration of 220.8 mg/kg bw/day.
Justification for selection of Effect on developmental toxicity: via oral route:
The fetotoxicity NOAEL (no observed adverse effect level) of 5-nitrosalicylic acid in rat by oral exposure was observed at a dose concentration of
220.8 mg/kg bw/day.
Justification for classification or non-classification
The chemical 5-nitrosalicylic acid does not exhibit toxicity to the reproductive system upto the doses mentioned in the study end points.
Additional information
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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