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Diss Factsheets

Administrative data

Description of key information

The substance 3-chloroaniline shows acute toxicity effect by the oral,inhalation and dermal route in category 3.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Principles of method if other than guideline:
The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to rat by the oral route.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
256 mg/kg bw
Based on:
test mat.
Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral lethal dose (LD50) of 3 -Chloroaniline in rat was found to be 256 mg/kg of body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the oral route in category 3.

Executive summary:

The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to rat by the oral route. The rats were given the test substance by the oral route at a dose concentration of 256 mg/kg of 3-chloroaniline.The lethal dose (LD50) of 3 -Chloroaniline in rat was found to be 256 mg/kg of body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the oral route in category 3.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
256 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Principles of method if other than guideline:
The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to mouse by the inhalative route.
GLP compliance:
not specified
Test type:
standard acute method
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LC50
Effect level:
550 other: mg/m3
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: LC50=550 mg/m3,when converted into mg/L it is equivalent to 0.55 mg/L.
Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The lethal concentration (LC50) of 3 -Chloroaniline in mouse by the inhalative route was found to be 550 mg/m3. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the inhalative route in category 3.
Executive summary:

The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to mouse by the inhalative route.The mouse were given the test substance by the inhalative route at a dose concentration of 550 mg/m3 of 3-chloroaniline.The lethal concentration (LC50) of 3 -Chloroaniline in mouse was found to be 550 mg/m3. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the inhalative route in category 3.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
550 mg/m³ air
Quality of whole database:
The data is K4 level.The data has been obtained from the experimental study from the journal of ‘Toxicometric Parameters of Industrial Toxic Chemicals Under Single Exposure'.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Principles of method if other than guideline:
The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to cat by the dermal route.
GLP compliance:
not specified
Test type:
standard acute method
Species:
cat
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
223 mg/kg bw
Based on:
test mat.
Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal lethal dose (LD50) of 3 -Chloroaniline in cat was found to be 223 mg/kg of body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the dermal route in category 3.
Executive summary:

The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to cat by the dermal route.The cat were given the test substance by the dermal route at a dose concentration of 223 mg/kg of 3-chloroaniline.The lethal dose (LD50) of 3 -Chloroaniline in cat was found to be 223 mg/kg of body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the dermal route in category 3.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
223 mg/kg bw
Quality of whole database:
The data is K4 level.The data has been obtained from the experimental study from the reliable journal ‘Gigiena Truda i Professional'nye Zabolevaniya'.

Additional information

Acute toxicity: oral

Based on various studies were reviewed for acute oral toxicity with Klimish rating 4 for the target as well as the read across substances for CAS: 108-42-9 considering the weight of evidence approach.

The results for target substance as well as analogues are summarized as follows

 Sr. No

Endpoint

Effect values

Species

Sources

1

LD50

256 mg/kg bw

Rat

Data from Publication for CAS :108-42-9

2

LD50

250 mg/kg bw

Guinea pig

Data from publication for CAS: 108-42-9

3

LD50

280 mg/kg bw

Rat

Data from publication for RA CAS: 108-45-2

 

Based on the studies summarized in the above table for target substance 3-chloroaniline and the read across substance m-phenylenediamine, the acute oral lethal dose (LD50) value was found to vary between 250 mg/kg bw to 280 mg/kg bw which qualifies for acute toxicity via the oral route as per CLP regulation. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3-chloroaniline exhibits acute toxicity via the oral route in the category 3.

Acute toxicity: inhalation

Based on various studies were reviewed for acute toxicity via the inhalation route for the target substances for CAS: 108-42-9 considering the weight of evidence approach.

The results for target substance are summarized as follows

Sr. No

Endpoint

Effect values

Species

Sources

1

LC50

550 mg/m3

Mouse

Data from Publication for CAS :108-42-9

2

LC50

500 – 800 mg/m3

Rat

Data from publication for CAS: 108-42-9

 

Based on the studies summarized in the above table for target substance 3-chloroaniline, the lethal concentration (LC50) value was found to vary between 500-800 mg/m3 which qualifies for acute toxicity via the inhalation route as per CLP regulation. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3-chloroaniline exhibits acute toxicity via the inhalation route in the category 3.

 

Acute toxicity: dermal

Based on various studies were reviewed for acute dermal toxicity for the target substance for CAS: 108-42-9 considering the weight of evidence approach.

The results for target substance are summarized as follows

 Sr. No

Endpoint

Effect values

Species

Sources

1

LD50

223 mg/kg bw

Cat

Data from Publication for CAS :108-42-9

2

LD50

250 mg/kg bw

Rat

Data from publication for CAS: 108-42-9

Based on the studies summarized in the above table for target substance 3-chloroaniline,the acute dermal lethal dose (LD50) value was found to vary between 223 mg/kg bw to 250 mg/kg bw which qualifies for acute toxicity via the dermal route as per CLP regulation. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3-chloroaniline exhibits acute toxicity via the dermal route in the category 3.

Justification for selection of acute toxicity – oral endpoint

The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to rat by the oral route. The rats were given the test substance by the oral route at a dose concentration of 256 mg/kg of 3-chloroaniline.The lethal dose (LD50) of 3 -Chloroaniline in rat was found to be 256 mg/kg of body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the oral route in category 3.

Justification for selection of acute toxicity – inhalation endpoint

The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to mouse by the inhalative route.The mouse were given the test substance by the inhalative route at a dose concentration of 550 mg/m3 of 3-chloroaniline.The lethal concentration (LC50) of 3 -Chloroaniline in mouse was found to be 550 mg/m3. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the inhalative route in category 3.

Justification for selection of acute toxicity – dermal endpoint

The acute toxicity study was conducted to evaluate the toxic effects of administration of 3-chloroaniline to cat by the dermal route.The cat were given the test substance by the dermal route at a dose concentration of 223 mg/kg of 3-chloroaniline.The lethal dose (LD50) of 3 -Chloroaniline in cat was found to be 223 mg/kg of body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that 3 -Chloroaniline exhibits acute toxicity via the dermal route in category 3.

Justification for classification or non-classification

Based upon the study results and available information,the substance 3-chloroaniline shows acute toxicity effect via the oral,inhalation and dermal route in category 3 as per CLP regulation.