4-nitroaniline

Endpoint summary

Description of key information

Though the supporting studies for acute oral toxicity for 4-nitroaniline indicate toxicity category IV, since 4-nitroaniline has a harmonized classification of acute oral Category III; therefore for the purpose of this dossier and chemical safety assessment the value of the key study shall be used.
For acute toxicity by the inhalation route; the key study does not indicate that 4-nitroaniline shall have toxic effect by the inhalation route. However since 4-nitroaniline has a harmonized classification of acute inhalation Category III; this dossier agrees to the harmonized classification though a key study is not available supporting the classification.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

standard acute method

GLP compliance:

not specified

Test type:

standard acute method

Species:

other: Bird - wild bird species

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

75 mg/kg bw

Based on:

test mat.

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The lethal dose value (LD50) causing acute oral toxicity to wild bird species is 75 mg/kg body weight. This value indicates that 4-nitroaniline shall exhibit acute oral toxicity Category III to birds as per the CLP criteria. This is in agreement with the harmonized system of classification for 4-Nitroaniline.

Executive summary:

The lethal dose value (LD50) causing acute oral toxicity to wild bird species is 75 mg/kg body weight. This value indicates that 4-nitroaniline shall exhibit acute oral toxicity of the level of Category III to birds as per the CLP criteria.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

75 mg/kg bw

Quality of whole database:

The key study is from an authoritative database. Supporting studies indicte that 4-nitroaniline shall exhibit acute oral toxicity in the Category IV. However, since this chemical has a harmonized classification within CLP, for the purpose of chemical safety report the key study LD50 value shall be used.

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:

other: Not Applicable;OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

other: Acute Rodent Inhalation Toxicity Test

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

inhalation

Type of inhalation exposure:

other: Inhalation: Vapor

Vehicle:

other: Unchanged (No Vehicle/Air)

Duration of exposure:

4 h

No. of animals per sex per dose:

6 animals

Control animals:

not specified

Sex:

male

Dose descriptor:

LC50

Effect level:

47.485 ppm

Based on:

test mat.

Exp. duration:

4 h

The prediction was based on dataset comprised from the following descriptors: LC50
Estimation method: Taking average value from the 4 nearest neighbours
Domain logical expression:Result: In Domain

("a" and ("b" and "c" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(N)ccc(N(=O)=O)cc1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Parametric boundary:The target chemical should have a value of log Kow which is >= 0.348

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is <= 2.58

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Inhalation toxicity (LC50 value) of 4-nitroaniline vapours was examined for 4 hrs.in male Wistar rat at a dose concentration (LC50) of 47.48475 ppm.This value suggests that the chemical 4-nitroaniline is non toxic to Wistar rat by the inhalation route.

Executive summary:

Inhalation toxicity (LC50 value) of 4-nitroaniline vapours was examined for 4 hrs.in male Wistar rat at a dose concentration (LC50) of 47.48475 ppm.This value suggests that the chemical 4-nitroaniline is non toxic to male Wistar rat by the inhalation route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

47.485 mg/m³ air

Quality of whole database:

SSS QSAR generated data

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

standard acute method

GLP compliance:

not specified

Test type:

standard acute method

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

not specified

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

test mat.

4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route according to Toxicity Category III.

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.

Executive summary:

4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

Quality of whole database:

4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.

Additional information

Acute oral toxicity:

The lethal dose value (LD50) causing acute oral toxicity to wild bird species is 75 mg/kg. This value indicates that 4-nitroaniline shall exhibit acute oral toxicity of the level of Category III to birds as per the CLP criteria.

Acute toxicity inhalation:-

Inhalation toxicity (LC50) of 4-nitroaniline vapours was examined for 4 hrs.in male Wistar rat at a dose concentration of 47.48475 ppm.This value

suggest that the chemical 4-nitroaniline is non toxic by inhalation route.

Acute dermal toxicity:

4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.

Justification for selection of acute toxicity – oral endpoint
The result is from an authoritative database and therefore was selected as a key study.

Justification for selection of acute toxicity – inhalation endpoint
The results obtained through QSAR do not indicate 4-nitroaniline to be toxic by the inhalation route. However, since this chemical has a harmonized classification within CLP, this chemical shall be considered to exhibit acute toxicity category 3 (by the inhalation route)

Justification for selection of acute toxicity – dermal endpoint
The result is from an authoritative database and therefore was selected as a key study.

Justification for classification or non-classification

All the values in the toxicity end point for the 4 nitro aniline indicate that the substance will certainly qualify for acute toxicity in category 3 for all the three routes of exporsure that is oral, dermal and inhalation.