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Administrative data

Description of key information

The substance is found to be non irritating to skin and eyes of rabbits

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41).
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data available
Type of coverage:
not specified
Preparation of test site:
other: intact and abraded skin
Vehicle:
other: Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3
Controls:
not specified
Amount / concentration applied:
2.5% (w/v) Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.
Duration of treatment / exposure:
no data
Observation period:
72-hr observation period
Number of animals:
3
Details on study design:
SCORING SYSTEM: Based on the definition of skin irritation given in the (Code of Federal Regulations, Title 16, Sec. 1500.41).
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hrs
Score:
0
Reversibility:
no data
Remarks on result:
other: No irritation was observed
Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine.According to the Code of Federal Regulations, Test for Skin Irritants, the primary irritation index for 2 nitro p phenylene diamine was scored as 0 , due to the no irritation observed during the 72 hour observation period.
Executive summary:

The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine. The albino rabbits used for the assessment of irritation potential were of the New Zealand White strain.

The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41). Each of the twelve compounds to be tested was applied as a 2.5% (w/v) preparation to the intact and abraded skin of three animals.

The primary irritation index was estimated to be 0 for test material as it showed no response to treatment during the 72-hr observation period.Based on the above information the test substancecan be classified as "not irritating: ,in accordence with CLP criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42).
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
other: Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.
Controls:
other: Other eye acted as control in all the groups
Amount / concentration applied:
2.5%(w/v) Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
No data
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Categorized as + or - according to whether extrapolation of the result would be expected to give a positive or negative test for eye irritation based on the definition in the Code of Federal Regulations, Test for Eye Irritants (Title 16, Sec. 1500.42).REMOVAL OF TEST SUBSTANCEWashing (if done): 50 ml of lukewarm water (37°C) Time after start of exposure: 10 seconds after instillation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hrs
Reversibility:
fully reversible
Remarks on result:
other: occasional transient mild conjunctival inflammation
Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.Thus, the substance is considered to be non irritating to eyes.
Executive summary:

The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.

 

The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42). 2 nitro p phenylenediamine was prepared as a 2.5% (w/v) solution or suspension. (Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3). Eleven groups of three rabbits were used to test solutions, each of which was instilled into one eye of each of three rabbits.

 

None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.

 

Thus, the substance is consudered to be non irritating to eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine. The albino rabbits used for the assessment of irritation potential were of the New Zealand White strain.

The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41). Each of the twelve compounds to be tested was applied as a 2.5% (w/v) preparation to the intact and abraded skin of three animal

The primary irritation index was estimated to be 0 for test material as it showed no response to treatment during the 72-hr observation period. In supporting study by (Danish (Q)SAR Database 2016),the skin irritation was observed . Skin irritation effects were estimated by three different models i.e, Battery and SciQSAR used within Danish QSAR database for chemical 2-nitro-p-phenylenediamine.

Based on estimation No severely skin irritation effect were known when test chemical2-nitro-p-phenylenediamine exposed to rabbit skin.

In another suppoting study by (KEMI Swedish Chemical Agency ,2011) with similar substance(89 -62 -3),the skin irritation was observed in rabbit. 2-nitro-p-toluidine is found to be non-irritating to skin of the rabbit.

On the basis of available information for the target and read across substance , the test substance can be considered as not irritating tothe skin, inaccordance with the CLP criteria.

Eye Irritation:

The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42). 2 nitro p phenylenediamine was prepared as a 2.5% (w/v) solution or suspension. (Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3). Eleven groups of three rabbits were used to test solutions, each of which was instilled into one eye of each of three rabbits. None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.Thus, the substance is consudered to be non irritating to eyes.

In another suppoting study by (ACTOR,2007) with similar substance(100 -01 -6),the eye irritation was observed in rabbit.

In-vivo studies on rabbits indicate that 4-nitroaniline was not irritating to eyes of rabbit.

Inanother suppoting study by ( KEMI,2011) with similar substance(89 -62 -3),the eye irritation was observed in rabbit.

2-nitro-p-toluidine is found to be non-irritating to eye of the rabbit as per the information available in the database of the Swedish chemical agency.

On the basis of available information for the target and read across substance , the test substance can be considered as not irritating tothe eye, inaccordance with the CLP criteria.


Justification for selection of skin irritation / corrosion endpoint:
The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine.
According to the Code of Federal Regulations, Test for Skin Irritants, the primary irritation index for 2 nitro p phenylene diamine was scored as 0 , due to the no irritation observed during the 72 hour observation period.

Justification for selection of eye irritation endpoint:
The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.
None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.
Thus, the substance is considered to be non irritating to eyes.

Justification for classification or non-classification

On the basis of available information, the substance, 2 nitro p phenylene diamine, is likely to be non irritating to skin and eyes.