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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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
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
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 air
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
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.