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Description of key information

Skin irritation

The dermal irritation potential of target chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) was assessedin various experimental studies which were conducted onguinea pigs and rabbitfor target chemical2,4,6-trichloroaniline (CAS No: 634-93-5) and its structurally similar read across substances.Based on the available data for the target and read across substances and applying the weight of evidence approach, it can be concluded that chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) is able to cause skin irritation and thus considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2 (irritant)”.

 

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5). Based on the summarized studies for target chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The skin irritation study of test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) was conducted on guinea pigs to observe its irritation efficacy.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,4,6-trichloroaniline
- Molecular formula: C6-H4-Cl3-N
- Molecular weight: 196.464 g/mol
- Smiles notation: c1(c(cc(Cl)cc1Cl)Cl)N
- InChl (if other than submission substance): 1S/C6H4Cl3N/c7-3-1-4(8)6(10)5(9)2-3/h1-2H,10H2
- Substance type: organic
- Physical state: Solid
Species:
guinea pig
Strain:
not specified
Details on test animals or test system and environmental conditions:
not specified
Type of coverage:
occlusive
Controls:
not specified
Amount / concentration applied:
Not specified
Duration of treatment / exposure:
24 hours
Observation period:
24 hours
Number of animals:
Not specified
Details on study design:
Not specified
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
slight irritation was observed in treated guinea pigs.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test material 2,4,6-trichloroaniline (CAS No: 634-93-5) was considered to be irritating to skin of guinea pigs.
Executive summary:

The skin irritation study of test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) was conducted on guinea pigs to observe its irritation efficacy.

 

When the chemical was applied on skin of guinea pigs for 24 hours, slight irritation was observed in treated guinea pigs.

 

Hence the test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) was considered to be irritating to the skin of guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on 2 eye irritation studies as- WoE-2 and WoE-3.
An eye irritation study of test chemical was conducted on rabbits to assess its eye irritating effects.
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,4,6-trichloroaniline
- Molecular formula: C6-H4-Cl3-N
- Molecular weight: 196.464 g/mol
- Smiles notation: c1(c(cc(Cl)cc1Cl)Cl)N
- InChl (if other than submission substance): 1S/C6H4Cl3N/c7-3-1-4(8)6(10)5(9)2-3/h1-2H,10H2
- Substance type: organic
- Physical state: Solid
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
not specified
Vehicle:
other: 1. unchanged (no vehicle) 2.not specified
Amount / concentration applied:
1.100% (undiluted)
2.100 mg
Duration of treatment / exposure:
1.72 hours
2.7 days
Observation period (in vivo):
1.72 hours
2.7 days
Duration of post- treatment incubation (in vitro):
not specified
Number of animals or in vitro replicates:
not specified
Details on study design:
1.- Area of exposure: conjunctival sac
2.REMOVAL OF TEST SUBSTANCE
- Area of exposure: conjunctival sac
- Washing (if done): rinsing after 30 sec, 5 min, 24 h or no rinsing
Irritation parameter:
other: 1.overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: 2.overall irritation score
Basis:
mean
Time point:
7 d
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
1.The chemical produced reddening and swelling of the conjunctiva for a short time. Only a few animals showed slight opacity of the cornea and this was reversible after 72 hours (as a rule).
2.The chemical produced reddening, conjunctival swelling and secretions of varied intensity. The effects were altogether weak and reversible within 7 days, even if the eye had not been rinsed.
Interpretation of results:
other: Not irritating
Conclusions:
The test material 2,4,6-trichloroaniline (CAS No: 634-93-5) was considered to be irritating to the rabbits' eye.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5). The studies are as mentioned below:

 

An eye irritation study was conducted by authoritative database to determine the adverse effects caused by the read across chemical.When the undiluted chemical was instilled into the eyes of each rabbit, the chemical producedreddening and swelling of the conjunctiva for a short time. Only a few animals showed slight opacity of the cornea and this was reversible after 72 hours (as a rule).Since the observed effects were not persisted during the observation period, the test chemical was considered to be not irritating to the eyes of rabbits.

 

An ocular irritation study of another read across chemical was conducted on rabbits to determine its irritation potential.About 100 mg of test chemical was instilled into the conjunctival sac of eyes of each rabbit (rinsing after 30 sec, 5 min, 24 h or no rinsing) which causedreddening, conjunctival swelling and secretions of varied intensity. The effects were altogether weak and reversible within 7 days, even if the eye had not been rinsed.Since the observed effects were cleared within 7 days, the test chemical was considered to be not irritating to the eyes of rabbits.

 

Based on the above summarized studies for target chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Various studieshas been investigated for the test chemical2,4,6-trichloroaniline (CAS No: 634-93-5)to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and rabbits for target chemical2,4,6-trichloroaniline (CAS No: 634-93-5) and its structurally similar read across substanceswhich have beensummarized as below;

 

The skin irritation study of test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) was reported by safety assessment report on guinea pigs to observe its irritation efficacy. When the chemical was applied on skin of guinea pigs for 24 hours, slight irritation was observed in treated guinea pigs. Hence the test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) was considered to be irritating to the skin of guinea pigs.

 

The above result was supported by the skin irritation study of similar read across chemical on skin of rabbits. About 500mg of test chemical was applied on the intact or abraded skin of rabbits and observed for skin reactions. After 24 hours the chemical caused erythema and oedema in all animals and after 72 hours erythema was seen in only 3 animals. On the basis of observed effects, the test chemical was considered as irritating to the skin.

 

The above results were further supported by the skin irritation study of another read across chemical conducted on guinea pigs. The test chemical was moistened with water and applied on skin of guinea pigs under occlusive condition. The animals were observed for skin irritation after 24 hours. The chemical caused moderate irritation on treated guinea pigs. Hence the chemical was considered to be irritating to the skin of guinea pigs.

 

Based on the available data for the target and read across substances and applying the weight of evidence approach,it can be concluded that thechemical 2,4,6-trichloroaniline (CAS No: 634-93-5) is able to cause skin irritation and considered as irritating.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2 (irritant)”.

 

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5). The studies are as mentioned below:

 

An eye irritation study was conducted by authoritative database to determine the adverse effects caused by the read across chemical.When the undiluted chemical was instilled into the eyes of each rabbit, the chemical producedreddening and swelling of the conjunctiva for a short time. Only a few animals showed slight opacity of the cornea and this was reversible after 72 hours (as a rule).Since the observed effects were not persisted during the observation period, the test chemical was considered to be not irritating to the eyes of rabbits.

 

An ocular irritation study of another read across chemical was conducted on rabbits to determine its irritation potential.About 100 mg of test chemical was instilled into the conjunctival sac of eyes of each rabbit (rinsing after 30 sec, 5 min, 24 h or no rinsing) which causedreddening, conjunctival swelling and secretions of varied intensity. The effects were altogether weak and reversible within 7 days, even if the eye had not been rinsed.Since the observed effects were cleared within 7 days, the test chemical was considered to be not irritating to the eyes of rabbits.

 

Based on the above summarized studies for target chemical 2,4,6-trichloroaniline (CAS No: 634-93-5) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical 2,4,6-trichloroaniline (CAS No: 634-93-5)  and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical  is likely to cause skin irritation but unable to cause eye irritation. Hence 2,4,6-trichloroaniline (CAS No: 634-93-5) can be classified under the category “Category 2 (irritant)” for skin and “Not Classified” for eye as per CLP.