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Description of key information

The substance 5-nitrosalicylic acid does not showed toxicity effect by oral,dermal and inhalation route within the dose levels mentioned in the respective end points.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
No. of animals per sex per dose:
6 animals
Control animals:
not specified
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
2 400 mg/kg bw
Based on:
test mat.





The prediction was based on dataset comprised from the following descriptors: "approx. LD50"
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 "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 Not possible to classify according to these rules (GSH) by Protein binding potency

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Moderately reactive (GSH) OR Moderately reactive (GSH) >> 2-Vinyl carboxamides (MA) by Protein binding potency

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as No superfragment by Superfragments

Domain logical expression index: "e"

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

Domain logical expression index: "f"

Parametric boundary:The target chemical should have a value of log Kow which is >= -2.29

Domain logical expression index: "g"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.23

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (approx. LD50) of 5-nitrosalicylic acid in rat was found to be 2400 mg/kg of body weight. Acute toxicity of 5-nitrosalicylic acid to male and female rat indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the oral route within above mention dose.
Executive summary:

The acute oral median lethal dose (approx. LD50) of 5-nitrosalicylic acid in rat was found to be 2400 mg/kg of body weight. Acute toxicity of 5-nitrosalicylic acid to male and female rat indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the oral route within above mention dose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 400 mg/kg bw
Quality of whole database:
The data is K2 level as the data has been obtained from QSAR model considered by OECD.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute 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:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
No. of animals per sex per dose:
6 animals
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LC50
Effect level:
1 255 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h





The prediction was based on dataset comprised from the following descriptors: LC50
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 "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 Group 14 - Carbon C AND Group 15 - Nitrogen N AND Group 16 - Oxygen O by Chemical elements

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Group 16 - Sulfur S OR Group 17 - Halogens Cl OR Group 17 - Halogens F OR Group 17 - Halogens F,Cl,Br,I,At by Chemical elements

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Bioavailable by Lipinski Rule Oasis

Domain logical expression index: "e"

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

Domain logical expression index: "f"

Parametric boundary:The target chemical should have a value of log Kow which is >= 2.36

Domain logical expression index: "g"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.37

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 4 hrs acute inhalation median lethal concentration (LC50) of 5-nitrosalicylic acid in rat was found to be 1255mg/L.Acute toxicity of 5-nitrosalicylic acid to rat by the inhalation route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the inhalative route within the doses mentioned.

Executive summary:

The 4 hrs acute inhalation median lethal concentration (LC50) of 5-nitrosalicylic acid in rat was found to be 1255mg/L.Acute toxicity of 5-nitrosalicylic acid to rat by the inhalation route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the inhalative route within the doses mentioned.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 255 mg/m³
Quality of whole database:
The data is K2 level as the data has been obtained from QSAR model considered by OECD.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute 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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
not specified
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
9 862.85 mg/kg bw
Based on:
test mat.





The prediction was based on dataset comprised from the following descriptors: LD50
Estimation method: Takes average value from the 6 nearest neighbours
Domain  logical expression:Result: In Domain

((((("a" and ("b" and ( not "c") )  )  and "d" )  and "e" )  and "f" )  and ("g" and "h" )  )

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 Group 14 - Carbon C AND Group 15 - Nitrogen N AND Group 16 - Oxygen O by Chemical elements

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr OR Group 14 - Metalloids Si,Ge OR Group 15 - Phosphorus P OR Group 16 - Sulfur S OR Group 17 - Halogens Cl OR Group 17 - Halogens F OR Group 17 - Halogens F,Cl,Br,I,At by Chemical elements

Domain logical expression index: "d"

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

Domain logical expression index: "e"

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

Domain logical expression index: "f"

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

Domain logical expression index: "g"

Parametric boundary:The target chemical should have a value of log Kow which is >= 1.03

Domain logical expression index: "h"

Parametric boundary:The target chemical should have a value of log Kow which is <= 3.74

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal concentration (LC50) of 5-nitrosalicylic acid in rabbit was found to be 9862.85 mg/L.Acute toxicity of 5-nitrosalicylic acid to rabbit by the dermal route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the dermal route within the doses mentioned.
Executive summary:

The acute dermal median lethal concentration (LC50) of 5-nitrosalicylic acid in rabbit was found to be 9862.85 mg/L.Acute toxicity of 5-nitrosalicylic acid to rabbit by the dermal route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the dermal route within the doses mentioned.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
9 862.85 mg/kg bw
Quality of whole database:
The data is K2 level as the data has been obtained from QSAR model considered by OECD.

Additional information

Acute toxicity: oral

The acute oral median lethal dose (approx. LD50) of 5-nitrosalicylic acid in rat was found to be 2400 mg/kg of body weight. Acute toxicity of 5-nitrosalicylic acid to male and female rat indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the oral route within above mention dose.

Acute toxicity: inhalation

The 4 hrs acute inhalation median lethal concentration (LC50) of 5-nitrosalicylic acid in rat was found to be 1255mg/L.Acute toxicity of 5-nitrosalicylic acid to rat by the inhalation route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the inhalative route within the doses mentioned.

Acute toxicity: dermal

The acute dermal median lethal concentration (LC50) of 5-nitrosalicylic acid in rabbit was found to be 9862.85 mg/L.Acute toxicity of 5-nitrosalicylic acid to rabbit by the dermal route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the dermal route within the doses mentioned.

Justification for selection of acute toxicity – oral endpoint

The acute oral median lethal dose (approx. LD50) of 5-nitrosalicylic acid in rat was found to be 2400 mg/kg of body weight. Acute toxicity of 5-nitrosalicylic acid to male and female rat indicates that 5-nitrosalicylic acid does not  exhibits acute toxicity by the oral route within above mention dose.

Justification for selection of acute toxicity – inhalation endpoint

The 4 hrs acute inhalation median lethal concentration (LC50) of 5-nitrosalicylic acid in rat was found to be 1255mg/L.Acute toxicity of 5-nitrosalicylic acid to rat by the inhalation route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the inhalative route within the doses mentioned.

Justification for selection of acute toxicity – dermal endpoint

The acute dermal median lethal concentration (LC50) of 5-nitrosalicylic acid in rabbit was found to be 9862.85 mg/L.Acute toxicity of 5-nitrosalicylic acid to rabbit by the dermal route indicates that 5-nitrosalicylic acid does not exhibits acute toxicity by the dermal route within the doses mentioned.

Justification for classification or non-classification

The substance 5-nitrosalicylic acid is not classified as per the C & L criteria set by EU.