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Administrative data

Description of key information

The substance 5-nitrosalicylic acid  does not exhibit repeated dose toxicity by oral,inhalation and dermal route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
452.16 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.

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: inhalation
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:
other: Estimated data
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.1
GLP compliance:
no
Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Control animals:
not specified
Dose descriptor:
LOEL
Effect level:
19.56 other: mg/kg/day
Based on:
test mat.
Sex:
male/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

The prediction was based on dataset comprised from the following descriptors: "study LOEL"
Estimation method: Takes average value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

((((("a" and "b" )  and "c" )  and "d" )  and "e" )  and ("f" and "g" )  )

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 Bioavailable by Lipinski Rule Oasis

Domain logical expression index: "c"

Similarity boundary:Target: C(=O)(O)c1c(O)ccc(N(=O)=O)c1
Threshold=10%,
Dice(Atom centered fragments)

Domain logical expression index: "d"

Similarity boundary:Target: C(=O)(O)c1c(O)ccc(N(=O)=O)c1
Threshold=20%,
Dice(Atom centered fragments)

Domain logical expression index: "e"

Similarity boundary:Target: C(=O)(O)c1c(O)ccc(N(=O)=O)c1
Threshold=30%,
Dice(Atom centered fragments)

Domain logical expression index: "f"

Parametric boundary:The target chemical should have a value of log Kow which is >= 1.81

Domain logical expression index: "g"

Parametric boundary:The target chemical should have a value of log Kow which is <= 3.1

Conclusions:
The repeated dose toxicity LOEL (Low observed effect level) of 5-nitrosalicylic acid to mouse by the inhalation route was estimated at a dose concentration of 19.56 mg/kg bw/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to mouse by the inhalative route below the above mentioned dose.
Executive summary:

The repeated dose toxicity LOEL (Low observed effect level) of 5-nitrosalicylic acid to mouse by the inhalation route was estimated at a dose concentration of 19.56 mg/kg bw/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to mouse by the inhalative route below the above mentioned dose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
19.56 mg/m³
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.

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
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:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Control animals:
not specified
Dose descriptor:
NOAEL
Effect level:
766.666 mg/kg bw/day
Based on:
test mat.
Sex:
male/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

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 "c" )  )

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"

Parametric boundary:The target chemical should have a value of log Kow which is >= -10.1

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is <= 2.69

Conclusions:
The repeated dose toxicity NOAEL (No observed adverse effect level) of 5-nitrosalicylic acid to rabbit by the dermal route was estimated at a dose concentration of 766.666 mg/kg bw/day.On the basis of this NOAEL value it is concluded that the test substance is not toxic to rabbit by the dermal
route.
Executive summary:

The repeated dose toxicity NOAEL (No observed adverse effect level) of 5-nitrosalicylic acid to rabbit by the dermal route was estimated at a dose concentration of 766.666 mg/kg bw/day.On the basis of this NOAEL value it is concluded that the test substance is not toxic to rabbit by the dermal route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
766.666 mg/kg bw/day
Study duration:
subacute
Species:
rabbit
Quality of whole database:
The data is K2 level as the data has been obtained from QSAR model considered by OECD.

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity: oral

The repeated dose toxicity LOEL (Lowest observed effect level) of 5-nitrosalicylic acid to rat by the oral (Feed) route was estimated at a dose concentration of 452.16 mg/kg bw/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to rat by the oral route below the above mentioned dose.

Repeated dose toxicity: inhalation

The repeated dose toxicity LOEL (Low observed effect level) of 5-nitrosalicylic acid to mouse by the inhalation route was estimated at a dose concentration of 19.56 mg/kg bw/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to mouse by the inhalative route below the above mentioned dose.

Repeated dose toxicity: dermal

The repeated dose toxicity NOAEL (No observed adverse effect level) of 5-nitrosalicylic acid to rabbit by the dermal route was estimated at a dose concentration of 766.666 mg/kg bw/day.On the basis of this NOAEL value it is concluded that the test substance is not toxic to rabbit by the dermal route.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

The repeated dose toxicity LOEL (Lowest observed effect level) of 5-nitrosalicylic acid to rat by the oral (Feed) route was estimated at a dose concentration of 452.16 mg/kg bw/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to rat by the oral route below  the above mentioned dose.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

The repeated dose toxicity LOEL (Low observed effect level) of 5-nitrosalicylic acid to mouse by the inhalation route was estimated at a dose concentration of 19.56 mg/kg bw/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to mouse by the inhalative route below the above mentioned dose.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:

The repeated dose toxicity NOAEL (No observed adverse effect level) of 5-nitrosalicylic acid to rabbit by the dermal route was estimated at a dose concentration of 766.666 mg/kg bw/day.On the basis of this NOAEL value it is concluded that the test substance is not toxic to rabbit by the dermal

route.

Justification for classification or non-classification

The substance 5-nitrosalicylic acid do not show repeated dose toxicity effect for oral,dermal and inhalation route and thus will not be considered for further classification.