2,4,6-trichloroaniline

Endpoint summary

Description of key information

Acute oral Toxicity: 

In Acute oral toxicity,LD50 value for target substance 2,4,6-trichloroaniline (634-93-5) was considered to be 1180 mg/kg bw in mouse; 1600-3200 mg/kg bw in rat;800-1600 mg/kg bw and 800 mg/kg bw in mouse. All these studies concluded that the LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,4,6-trichloroaniline (634-93-5) can be classified as “Category IV” for acute oral toxicity.

Acute Inhalation Toxicity: 

2,4,6-trichloroaniline (634-93-5) has very low vapour pressure (0.0000195 Pa. = 1.4626200729e-7 P mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.

Acute Dermal Toxicity:

The acute dermal toxicity dose (LD50) for 2,4,6-trichloroaniline (634-93-5) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,4,6-trichloroaniline (634-93-5) cannot be classified for acute dermal toxicity. 

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)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from authoritative database

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of test chemical was performed in rodents.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material: 2,4,6-trichloroaniline
- Molecular formula : C6H4Cl3N
- Molecular weight : 196.464 g/mol
- Substance type: Organic
- Physical state: Solid

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Vehicle:

not specified

Details on oral exposure:

not specified

Doses:

1180 mg/kg bw

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

Details on study design:
- Other examinations performed: clinical signs

Statistics:

not specified

Preliminary study:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 180 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Mortality:

50% mortality was observed at dose 1180 mg/kg bw

Clinical signs:

other: In Clinical signs observations, behavioral changes in motor activity (specific assay); convulsions or effect on seizure threshold;Somnolence (general depressed activity) were seen.

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The lethal concentration (LD50) value for acute oral toxicity test was considered to be 1180 mg/kg bw,when mouse were treated with 2,4,6-trichloroaniline (634-93-5) orally.

Executive summary:

Acute oral toxicity study was performed in mouse using test chemical.50% mortality was observed at dose 1180 mg/kg bw. Hence,LD50 value was considered to be 1180 mg/kg bw,when mouse were treated with 2,4,6-trichloroaniline (634-93-5)orally.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 180 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from authoritative database

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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 two acute dermal toxicity studies as-
1.and 2. Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material: 2,4,6-trichloroaniline
- Molecular formula : C6-H4-Cl3-N
- Molecular weight : 196.464
- Substance type: Organic
- Physical state: Solid

Species:

other: 1. rabbit 2. rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

other: dermal

Vehicle:

not specified

Details on dermal exposure:

no data

Duration of exposure:

no data

Doses:

1.2000 mg/kg bw
2.6139 mg/kg bw

No. of animals per sex per dose:

No data

Control animals:

not specified

Details on study design:

1.No data
2.Details on study design:
- Other examinations performed: clinical signs

Statistics:

No data

Preliminary study:

No data

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Sex:

not specified

Dose descriptor:

LD50

Effect level:

6 139 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Mortality:

1.No mortality was observed at dose 2000 mg/kg bw
2.50% mortality was observed at dose 6139 mg/kg bw

Clinical signs:

other: 1.No data 2.In Clinical signs observations, behavioral somnolence (general depressed activity) and convulsions or effect on seizure threshold were seen.

Gross pathology:

No data

Other findings:

No data

Interpretation of results:

other: not classified

Conclusions:

According to CLP regulation,the test chemical 2,4,6-trichloroaniline (CAS no.: 634-93-5) cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical 2,4,6-trichloroaniline (CAS no.: 634-93-5).The studies are as mentioned below:

1.In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 2000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 2000 mg/kg bw.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rabbits were treated with test chemical by dermal application.  

2.In acute dermal toxicity study, rats were treated with test chemical in the concentration of 6139 mg/kg bw by dermal application.No mortality was observed in treated rats at dose 6139 mg/kg bw.Therefore, LD50 value was considered to be 6139 mg/kg bw,when rats were treated with test chemical by dermal application.  

Thus, based on the above summarised studies, 2,4,6-trichloroaniline (CAS no.: 634-93-5) and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,4,6-trichloroaniline (CAS no.: 634-93-5)cannot be classified for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 139 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from authoritative database

Additional information

Acute Oral Toxicity: 

In different studies, 2,4,6-trichloroaniline (634-93-5) has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experimental data in rodents, i.e. most commonly in rats for 2,4,6-trichloroaniline (634-93-5). The studies are summarized as below –

The experimental study mentioned in authoritative database (2018) and handbook (2012) and secondary source (2018) for the target chemical2,4,6-trichloroaniline (634-93-5)was designed and conducted for acute oral toxicity.Acute oral toxicity study was performed in mouse using test chemical.50% mortality was observed at dose 1180 mg/kg bw. Hence,LD50 value was considered to be 1180 mg/kg bw,when mouse were treated with 2,4,6-trichloroaniline (634-93-5)orally.

The above study is supported by another experimental study performed in rat and mouse which is mentioned in secondary source (1984) for the target chemical2,4,6-trichloroaniline (634-93-5)was designed and conducted for acute oral toxicity.Acute oral toxicity study was performed for the test material 2, 4, 6 trichloroaniline (634 -93 -5) in rats and mouse. The compound is slightly toxic having an acute oral LD50 value to be 1600-3200 mg/kg bw in rats and 800 -1600 mg/kg bw in mouse.

Based on the QSAR prediction done using the Danish (Q)SAR Database,the LD50 was estimated to be 800 mg/kg bw on mouse for 2,4,6-trichloroaniline (634-93-5) having Reliability Index: 0.74 (moderate prediction quality).

Thus, based on the above summarised studies on2,4,6-trichloroaniline (634-93-5), it can be concluded that LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,2,4,6-trichloroaniline (634-93-5) can be classified as “Category IV” for acute oral toxicity.

Acute Inhalation Toxicity: 

2,4,6-trichloroaniline (634-93-5) has very low vapour pressure (0.0000195 Pa. = 1.4626200729e-7 P mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.

Acute Dermal Toxicity:

Data available for the structurally similar read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical 2,4,6-trichloroaniline (CAS no.: 634-93-5).The studies are as mentioned below:

1.In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 2000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 2000 mg/kg bw.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rabbits were treated with test chemical by dermal application.  

2.In acute dermal toxicity study, rats were treated with test chemical in the concentration of 6139 mg/kg bw by dermal application.No mortality was observed in treated rats at dose 6139 mg/kg bw.Therefore, LD50 value was considered to be 6139 mg/kg bw,when rats were treated with test chemical by dermal application.  

Thus, based on the above summarised studies, 2,4,6-trichloroaniline (CAS no.: 634-93-5) and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,4,6-trichloroaniline (CAS no.: 634-93-5)cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above experimental studies on 2,4,6-trichloroaniline (CAS no.: 634-93-5)and it’s structurally similar read across substances, it can be concluded that LD50 value is between 300-2000 mg/kg bw for acute oral and >2000 mg/kg bw for acute dermal toxicity.Thus, comparing this value with the criteria of CLP regulation,2,4,6-trichloroaniline (CAS no.: 634-93-5) can be classified as “Category IV” for acute oral toxicityfor acute oral toxicity and cannot be classified for acute dermal toxicity.For Acute inhalation toxicity wavier was added so, not possible to classify.