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Description of key information

Skin Irritation

In a skin irritation test in rabbits with 0.5 ml, 2.5%w/v 2-chloro-p-phenylenediamine in distilled water , no irritation  was observed after 24 and 72 hours of observation period. Thus, the test chemical 2-chloro-p-phenylenediamine can be judged as a non irritant.

Eye Irritation

The substance 2-chloro-p-phenylenediamine is non-irritating to the 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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal.
Qualifier:
no guideline available
Principles of method if other than guideline:
The skin irritation study was conducted on albino rabbits to assess the irritation potential of 2-chloro-p-phenylenediamine.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-chloro-p-phenylenediamine
- Molecular formula: C6H7N2Cl
- Molecular weight: 142.588 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: 99%
- Impurities (identity and concentrations):1 %
Species:
rabbit
Strain:
not specified
Remarks:
Albino
Details on test animals or test system and environmental conditions:
Albino rabbits were used for the study.
Type of coverage:
other: Patch tests
Preparation of test site:
other: one intact and one abraded site
Vehicle:
water
Remarks:
Distilled water
Controls:
not specified
Amount / concentration applied:
0.5 ml of 2.5% w/v 2-chloro-p-phenylenediamine in distilled water.
Observation period:
24 hours and 72 hours
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: one intact and one abraded site on the dorsum
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

SCORING SYSTEM: After 24 hours of exposure, the patches were removed and the test sites scored on a scale of 0 to 4 (CFR, Title 16, Section 1500.41). Sites were scored again 72 h after the application.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: No observable response were observed
Irritant / corrosive response data:
None of the animals showed any observable response to treatment throughout the 72 hours observation period.
Interpretation of results:
other: not irritating based on CLP criteria
Conclusions:
In a skin irritation test in rabbits with 0.5 ml, 2.5%w/v 2-chloro-p-phenylenediamine in distilled water , no irritation was observed after 24 and 72 hours of observation period.
Thus, the test chemical 2-chloro-p-phenylenediamine can be judged as a non irritant.
Executive summary:

The skin irritation study was conducted on albino rabbits to assess the irritation potential of the test compound 2-chloro-p-phenylenediamine. 3 albino rabbits were clipped free of hair. A patch with 0.5 ml of 2.5% w/v 2-chloro-p-phenylenediamine in distilled water was applied to both one abraded and one intact site on each animal. After 24 hours of exposure, the patches were removed and the test sites scored on a scale of 0 to 4 (CFR, Title 16, Section 1500.41). Sites were scored again 72 h after the application. None of the animals showed any observable response to treatment throughout the 72 hours observation period. Thus, based on the study 2-chloro-p-phenylenediamine (CAS No: 615-66-7) is not considered to be an irritant to rabbit skin and being classified as "not classified" as per CLP regulation.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal.
Qualifier:
no guideline available
Principles of method if other than guideline:
Eye irritation study was conducted on rabbits to evaluate the irritation potential of the test compound 2-chloro-p-phenylenediamine (CAS No.- 615 -66-7).
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report):2-chloro-p-phenylenediamine
- Molecular formula:C6-H7-Cl-N2
- Molecular weight:142.588 g/mole
- Substance type:Organic
- Physical state:Solid
- Purity: 99%
- Impurities (identity and concentrations): 1 %
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available
Vehicle:
water
Remarks:
Water buffered to pH 7 with 0.05% sodium sulfite
Controls:
not specified
Amount / concentration applied:
2.5 % (w/v)
Duration of treatment / exposure:
No data available
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: Eye
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were rinsed with 20 mL of distilled water.
- Time after start of exposure: Ten seconds

SCORING SYSTEM: No data available
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
other: non-irritating
Irritant / corrosive response data:
One animal showed mild conjunctival inflammation. Two animals did not show any observable response to treatment throughout the 7 days observa tion period.
Interpretation of results:
other: not irritating based on CLP criteria
Conclusions:
The substance 2-chloro-p-phenylenediamine is non-irritating to the eyes of rabbits.
Executive summary:

Eye irritation study was conducted on 3 rabbits to evaluate the irritation potential of the test compound 2-chloro-p-phenylenediamine (CAS No.- 615 -66 -7). 2.5% (w/v) 2-chloro-p-phenylenediamine in water (pH 7) was instilled into one eye of each of the three rabbits. Ten seconds after instillation the eyes were rinsed with 20 mL of distilled water.  

In one animal mild conjunctival inflammation was observed. Two animals did not show any observable response to treatment throughout the 7 days observati on period.  

2-chloro-p-phenylenediamine is non-irritating to the eyes of rabbits and being classified as "not classified" as per CLP regulation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

The test compound 2-chloro-p-phenylenediamine (CAS No: 615-66-7) was investigated for its dermal irritation potential to a greater or lesser extent. Often are the studies based on in vivo experiment and estimated data in rodents, i.e. most commonly in rabbits for 2-chloro-p-phenylenediamine. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data. The studies are summarized as below:

 

The skin irritation study was conducted by Lynn Willis (Journal Of The American College Of Toxicology Volume 11, Number 4,1992) on albino rabbits to assess the irritation potential of the test compound 2-chloro-p-phenylenediamine. 3 albino rabbits were clipped free of hair. A patch with 0.5 ml of 2.5% w/v 2-chloro-p-phenylenediamine in distilled water was applied to both one abraded and one intact site on each animal. After 24 hours of exposure, the patches were removed and the test sites scored on a scale of 0 to 4 (CFR, Title 16, Section 1500.41). Sites were scored again 72 h after the application. None of the animals showed any observable response to treatment throughout the 72 hours observation period. Thus, based on the study 2-chloro-p-phenylenediamine (CAS No: 615-66-7) is not considered to be an irritant to rabbit skin.

 

Moreover, the skin irritation potential of 2-chloro-p-phenylenediamine (CAS No: 615-66-7) was estimated using OECD QSAR toolbox version 3.3 with log Kow as the primary descriptor. The substance 2-chloro-p-phenylenediamine (CAS No: 615-66-7) was estimated to be not irritating to the skin of New Zealand White rabbits.

 

Thus, on the basis of the above studies for the target substance, it was concluded that 2-chloro-p-phenylenediam ine (CAS No: 615-66-7) was considered to be not irritating to the skin and being classified as “Not Classified” as per CLP Regulation.

Eye irritation

The test compound 2-chloro-p-phenylenediamine (CAS No: 615-66-7) was investigated for its ocular irritation potential to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rabbits for 2-chloro-p-phenylenediamine. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data. The studies are summarized as below:

 

Eye irritation study was conducted by Lynn Willis (Journal Of The American College Of Toxicology Volume 11, Number 4,1992) on 3 rabbits to evaluate the irritation potential of the test compound 2-chloro-p-phenylenediamine (CAS No.- 615 -66 -7). 2.5% (w/v) 2-chloro-p-phenylenediamine in water (pH 7) was instilled into one eye of each of the three rabbits. Ten seconds after instillation the eyes were rinsed with 20 mL of distilled water.  In one animal mild conjunctival inflammation was observed. Two animals did not show any observable response to treatment throughout the 7 days observati on peri od. Thus, based on the study 2-chloro-p-phenylenediamine is non-irritating to the eyes of rabbits.

 

Moreover, the ocular irritation potential of 2-chloro-p-phenylenediamine (CAS No: 615-66-7) was estimated using OECD QSAR toolbox version 3.3 with log Kow as the primary descriptor. 2-chloro-p-phenylenediamine (CAS No: 615-66-7) was estimated to be not irritating to the eyes of albino rabbits.

 

Thus, on the basis of the above studies for the target substance, it was concluded that 2-chloro-p-phenylenediami ne (CAS No: 615-66-7) was not considered to be an irritant to eyes and being classified as “Not Classified” as per CLP Regulation.

Justification for classification or non-classification

According to CLP Regulation EC No. 1272/2008 and based on the studies of skin and eye irritation, it is concluded that the substance 2-chloro-p-phenylene diamine is ‘’not classified’’as skin and eye irritant.

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