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Diss Factsheets

Administrative data

Description of key information

Skin irritation:

Skin irritation study was conducted to determine the adverse effects caused by the chemical 2-CHLORO-4-NITROPHENOL (CAS No: 619-08-9) by performing Draize test. The PII value observed for the chemical was 0.95. Thus on the basis of score, the chemical 2-CHLOR0-4-NITROPHENOL (CAS No: 619-08-9) was considered to be mild irritant to skin and can be classified under the category “Category 2” as per CLP regulation.

 

Eye irritation:

An eye irritation study was conducted on rabbits to determine the adverse effects caused by the chemical 2-CHLORO-4-NITROPHENOL (CAS No: 619-08-9) by performing Draize test. The chemical produced PII value of 34 out of maximum score of 110 when the chemical installed into the eye of each rabbit. Therefore 2-CHLORO-4-NITROPHENOL (CAS No: 619-08-9) was considered to be moderately irritating to the eye of rabbitsand can be classified under the category “Category 2” as per CLP regulation.

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:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal.
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin irritation study was conducted on rabbits to determine the adverse effects caused by the chemical 2-CHLORO-4-NITROPHENOL (CAS No: 619-08-9) by performing Draize test.
GLP compliance:
not specified
Specific details on test material used for the study:
- IUPAC Name: 2-chloro-4-nitrophenol
- Common Name: Nitrofungin
- Mol. formula: C6H4ClNO3
- Molecular Weight: 173.555 g/mol
- Smiles: c1(cc(c(O)cc1)Cl)[N+](=O)[O-]
- InChI: 1S/C6H4ClNO3/c7-5-3-4(8(10)11)1-2-6(5)9/h1-3,9H
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
intact
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data available
Duration of treatment / exposure:
4 hour
Observation period:
24, 48 and 72 hours
Number of animals:
6
Details on study design:
Details on study design
TEST SITE
- Area of exposure: clipped dorsum of the rabbit
- Type of wrap if used: The patches are secured by adhesive tape and the entire trunk of the animal is wrapped in a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24hr

SCORING SYSTEM: According to Draize method. (Draize, 1944)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0.95
Max. score:
8
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
mild irritation was observed in treated rabbits.

OBSERVATION TABLE

1.           Erythema and Eschar Formation

              No erythema....................................................................................... 0

              Very slight erythema (barely perceptible)............................................... 1

              Well defined erythema......................................................................... 2

              Moderate to severe erythema............................................................... 3

              Severe erythema (beet redness) to slight

              Eschar formation (injuries in depth)....................................................... 4

              Maximum possible = 4

 

2.           Oedema Formation

              No oedema......................................................................................... 0

              Very slight edema (barely perceptible)................................................... 1

              Slight edema (edges of area well defined by definite raising).................... 2

              Moderate edema (raised approximately 1 mm........................................ 3

              Severe edema (raised more than 1 mm and extending

              Beyond area of exposure)......................................................................4

               Maximum possible = 4

 

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The PII value observed for the chemical was 0.95. Thus on the basis of score, the chemical 2-CHLOR0-4-NITROPHENOL (619-08-9) was considered to be mild irritant to skin.
Executive summary:

Skin irritation study was conducted to determine the adverse effects caused by the chemical 2-CHLORO-4-NITROPHENOL (CAS No:619-08-9) by performing Draize test.

 

In the Draize skin irritation test, the test material is introduced under gauze patches to intact sites on the clipped dorsum of the rabbit. Applications are normally made on 6 rabbits. The patches are secured by adhesive tape and the entire trunk of the animal is wrapped in a semi-occlusive dressing for 4 h. After 4 h the patches are removed, the test sites cleaned, and any resulting reaction graded for erythema and oedema. The reactions are also scored at 24, 48, and 72 h (Draize, 1944). Skin reactions are graded separately for erythema/eschar and edema, each on a 0–4 grading scale.

 

These grades are averaged across all animals and grading time points, and then the averages are combined to derive a primary index (PII). Test materials producing PII values less than 2 are considered mildly irritating, 2 to 5 are moderately irritating, and greater than 5 are severely irritating.

 

The PII value observed for the chemical was 0.95. Thus on the basis of score, the chemical 2-CHLOR0-4-NITROPHENOL (619-08-9) was considered to be mild irritant to skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal.
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An eye irritation study was conducted on rabbits to determine the adverse effects caused by the chemical 2-CHLORO-4-NITROPHENOL (CAS No:619-08-9) by performing Draize test.
GLP compliance:
not specified
Specific details on test material used for the study:
- IUPAC Name: 2-chloro-4-nitrophenol
- Common Name: Nitrofungin
- Mol. formula: C6H4ClNO3
- Molecular Weight: 173.555 g/mol
- Smiles: c1(cc(c(O)cc1)Cl)[N+](=O)[O-]
- InChI: 1S/C6H4ClNO3/c7-5-3-4(8(10)11)1-2-6(5)9/h1-3,9H
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data available
Duration of treatment / exposure:
No data available
Observation period (in vivo):
No data available
Duration of post- treatment incubation (in vitro):
No data available
Number of animals or in vitro replicates:
No data available
Details on study design:
No data available
Irritation parameter:
overall irritation score
Basis:
mean
Score:
34
Max. score:
110
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
moderate irriation was observed in treated rabbits.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The chemical produced PII value of 34 out of maximum score of 110 when the chemical installed into the eye of each rabbit.

Therefore 2-CHLORO-4-NITROPHENOL (619-08-9) was considered to be Moderately irritating to the eye of rabbits.
Executive summary:

An eye irritation study was conducted on rabbits to determine the adverse effects caused by the chemical 2-CHLORO-4-NITROPHENOL (619-08-9) by performing Draize test.

 

The chemical produced PII value of 34 out of maximum score of 110 when the chemical installed into the eye of each rabbit.

 

Therefore 2-CHLORO-4-NITROPHENOL (619-08-9) was considered to be Moderately irritating to the eye of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Various studieshas been investigated for the test chemical2-chloro- 4-nitrophenol (CAS No: 619-08-9)to observe the potential for skin irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical2-chloro- 4-nitrophenol (CAS No: 619-08-9) and its structurally similar read across substances1,2-Dichloro-4-nitrobenzene (CAS no: 99-54-7)andSodium m-Nitrobenzenesulfonate (CAS no: 127-68-4)which have been summarized as below;

 

The Kiran Kodithala et al., {TOXICOLOGICAL SCIENCES 66, 336–346 (2002)}conducted skin irritation study to determine the adverse effects caused by the test chemical 2-CHLORO-4-NITROPHENOL (CAS No: 619-08-9) by performing Draize test. In the Draize skin irritation test, the test material is introduced under gauze patches to intact sites on the clipped dorsum of the rabbit. Applications are normally made on 6 rabbits. The patches are secured by adhesive tape and the entire trunk of the animal is wrapped in a semi-occlusive dressing for 4 h. After 4 h the patches are removed, the test sites cleaned, and any resulting reaction graded for erythema and oedema. The reactions are also scored at 24, 48, and 72 h (Draize, 1944). Skin reactions are graded separately for erythema/eschar and edema, each on a 0–4 grading scale. These grades are averaged across all animals and grading time points, and then the averages are combined to derive a primary index (PII). Test materials producing PII values less than 2 are considered mildly irritating, 2 to 5 are moderately irritating, and greater than 5 are severely irritating. The PII value observed for the chemical was 0.95. Thus on the basis of score, the chemical 2-CHLOR0-4-NITROPHENOL (CAS No: 619-08-9) was considered to be mild irritant to skin.

 

Another skin irritation study was conducted for the target chemical2-CHLORO-4-NITROPHENOL (CAS No:619-08-9) by NTRL (National Technical Reports Library) {OTS0570573; 08/28/92} on albino rabbits according to the method of Draize, Woodard and Calvery. The study was carried out by applying the dry substance on closely clipped intact skin and the degree of irritation score was calculated based on Draize test. The patch was removed after 24 hours and compound was brushed off. After 2 hours, there was very slight erythema on two animals and well defined redness on the third one for an average score of 1.5 for out of possible 8.0. Overnight the average score increased to 1.6 consisting of erythema with no edema. A trace of redness persisted in all animals until the third day when two were given a score of zero. The resulted average score was 1.6 out of possible score of 8. Thus under the test condition, the chemical 2-CHLORO-4-NITROPHENOL (CAS No:619-08-9) can be considered as mild skin irritant in dry form.

 

The above results were supported by the patch test study of read across substance 1,2-Dichloro-4-nitrobenzene (CAS no: 99-54-7) conducted on six rabbits under occlusive condition by theMAK Collection for Occupational Health and Safety{1,2-Dichlor-4-nitrobenzol [MAK Value Documentation in German language, 2006]. The MAK Collection for Occupational Health and Safety. 1–14. 2012.} The chemical was applied at 10% dilution in in sesame oil on the intact and scarified skin of each rabbits under occlusive conditions at 24 hours exposure time and skin reactions were examined at 24 and 72 hours. The observed mean follow-up index (24-72 hours) was 0.58 out of a maximum of 8. Since the chemical produced slight irritation, 1,2-Dichloro-4-nitrobenzene (CAS no: 99-54-7) was considered to be slightly irritating to the intact and scarified skin of six rabbits.

 

The above results were further supported by the dermal irritation study carried out by Cosmetic Ingredient Review Expert Panel{Journal of the American College of Toxicology 15(4):337-347,} on read across substanceSodium m-Nitrobenzenesulfonate (CAS no: 127-68-4).The chemical was applied dermally at a dose of 500 mg for 24 hours onto the skin of each rabbits, which produced moderate irritation. Therefore the chemicalSodium m-Nitrobenzenesulfonate (CAS no: 127-68-4)was considered to be moderately irritating to the skin of rabbits.

 

Based on the available data for the target as well as it read across substances and applying the weight of evidence approach, it can be concluded that 2-chloro- 4-nitrophenol (CAS No: 619-08-9) was irritating to skin. Comparing the above annotations with the criteria of CLP regulation, 2-chloro- 4-nitrophenol (CAS No: 619-08-9) can be classified under the category “Category 2”.

 

Eye irritation

Various studieshas been investigated for the test chemical2-chloro- 4-nitrophenol (CAS No: 619-08-9)to observe the potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical2-chloro- 4-nitrophenol (CAS No: 619-08-9) and its structurally similar read across substances1,2-Dichloro-4-nitrobenzene (CAS no: 99-54-7)andSodium m-Nitrobenzenesulfonate (CAS no: 127-68-4)which have been summarized as below;

 

The Kiran Kodithala et al., {TOXICOLOGICAL SCIENCES 66, 336–346 (2002)}conducted an eye irritation study to determine the adverse effects caused by the test chemical 2-CHLORO-4-NITROPHENOL (CAS No: 619-08-9) by performing Draize test.The chemical produced PII value of 34 out of maximum score of 110 when the chemical installed into the eye of each rabbit. Therefore 2-CHLORO-4-NITROPHENOL (CAS No:619-08-9) was considered to be moderately irritating to the eye of rabbits.

 

Another eye irritation study was conducted for the target chemical2-CHLORO-4-NITROPHENOL (CAS No:619-08-9)byNTRL (National Technical Reports Library) {OTS0570573; 08/28/92} onalbino rabbitsvia Draize method.Three albino rabbits were applied few milligrams of finely grounded powdered substance in right eye resulted in to the inflammation score according to Draize test. The animals were observed for 120 hours and the possible maximum score was 110. The average score after 120 hours was 2.0.No permanent damage to iris or cornea observed.Severe erythema and edema of lids about half closed with excessive lacrimation. Eris was cloudy and somewhat congested although still reacting to light. Two of the animals show worsened condition overnight leading to the score of 34.0. Some improvement was observed by third day with average score of 12.0. One animal was free from inflammation after five day and there was no permanent damage to cornea or iris.Hence based on the irritation score the 2-chloro- 4-nitrophenol (CAS No: 619-08-9) was considered to be irritating to the eyes of rabbits.

 

The above results were supported by the ocular irritation study of read across substance 1,2-Dichloro-4-nitrobenzene (CAS no: 99-54-7) conducted on three rabbits by theMAK Collection for Occupational Health and Safety{1,2-Dichlor-4-nitrobenzol [MAK Value Documentation in German language, 2006]. The MAK Collection for Occupational Health and Safety. 1–14. 2012.}. In three other rabbits, the introduction of 0.1 ml (presumably 100 mg) of undiluted 1,2-dichloro-4-nitrobenzene into the conjunctival sac of the eye was moderately irritating and led to tear flow, moderate erythema and edema, corneal clouding. After 72 hours inflammatory signs were still visible, which were reversible after five days. The observed mean follow-up index (24-72 hours) was 6.5 out of a maximum of 110. Since the chemical produced moderate irritation, 1,2-Dichloro-4-nitrobenzene (CAS no: 99-54-7) was considered to be moderately irritating to the eyes of rabbits.

 

The above results were further supported by an eye irritation study carried out by Cosmetic Ingredient Review Expert Panel{Journal of the American College of Toxicology 15(4):337-347,} on read across substanceSodium m-Nitrobenzenesulfonate (CAS no: 127-68-4).The chemical was installed at a dose of 20 mg for 24 hours into the eye of each rabbits, which produced moderate irritation. Therefore the chemicalSodium m-Nitrobenzenesulfonate (CAS no: 127-68-4)was considered to be moderately irritating to the eye of rabbits.

 

Based on the available data for the target as well as it read across substances and applying the weight of evidence approach, it can be concluded that 2-chloro- 4-nitrophenol (CAS No: 619-08-9) was irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, 2-chloro- 4-nitrophenol (CAS No: 619-08-9) can be classified under the category “Category 2”. 

 

Justification for classification or non-classification

The skin and eye irritation potential of test chemical2-chloro- 4-nitrophenol (CAS No: 619-08-9) and its structurally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical 2-chloro- 4-nitrophenolis likely to cause skin and eye irritation. Hence 2-chloro- 4-nitrophenol (CAS No: 619-08-9)can be classified under the category “Category 2” for skin and eye as per CLP.