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Administrative data

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on guinea pig for the test chemical 2, 5-Dichloronitrobenzene. The LD50 value is 800 mg/kg bw. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.

Acute Inhalation Toxicity:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.005 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on study conducted on rats for the given test chemical 2, 5-Dichloronitrobenzene. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical 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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
2, 5-Dichloronitrobenzene was evaluated for its toxic nature upon its acute oral administration in Guinea pigs.
GLP compliance:
not specified
Test type:
other: No data available
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route of administration:
oral: gavage
Vehicle:
other: 5% gum acacia solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1200, 1000, 800, 600 and 500 mg/Kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Doses:
1200, 1000, 800, 600 and 500 mg/Kg
No. of animals per sex per dose:
14
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
800 mg/kg bw
Based on:
test mat.
Clinical signs:
2, 5 dichloronitrobenzene was fairly toxic and likewise produced some irritation in the kidneys.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral LD50 for the test material 2, 5 dichloronitrobenzene is found to be 800mg/Kg.
Executive summary:

2, 5-Dichloronitrobenzene was evaluated for its toxic nature upon its acute oral administration in Guinea pigs.

 

The test compoundwas fairly toxic and likewise produced some irritation in the kidneys.

 

The acute oral LD50 for the test material2, 5 dichloronitrobenzene is found to be 800mg/Kg.

 

According to the publication, the test material classifies as an acute toxicant Category 4 chemical.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
800 mg/kg bw
Quality of whole database:
Data is secondary source (K4)

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
Acute dermal toxicity of chemical 2,5-Dichloronitrobenzene was determined in rats
GLP compliance:
not specified
Test type:
other: no data
Species:
rat
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: not classified
Conclusions:
The LD50 value was found to be >2000 mg/kg in rats exposed to chemical 2,5-Dichloronitrobenzene in acute dermal test.
Executive summary:

Acute dermal toxiciyt test was performed to evaluate lethality of chemical 2,5-Dichloronitrobenzene.The animals were exposed by dermal route with dose concentration of 2000 mg/kg.

The animal only showed only a decrease of their spontaneous activity.2000 mg/kg did not lead to any deaths for rats.

The LD50 value was found to be >2000 mg/kg in rats exposed to chemical 2,5-Dichloronitrobenzene in acute dermal test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Data is from authoritative database (K2)

Additional information

Acute oral toxicity

Various experimental studies of the test chemical were reviewed for acute oral toxicity endpoint which are summarised as below:

 

In an experimental key study from secondary source, test chemical 2, 5-Dichloronitrobenzene was evaluated for its toxic nature upon its acute oral administration in Guinea pigs. The test compound was fairly toxic and likewise produced some irritation in the kidneys. The acute oral LD50 for the test material 2, 5 dichloronitrobenzene is found to be 800mg/Kg. According to the publication, the test material classifies as an acute toxicant Category 4 chemical.

 

For the test chemical 2, 5-Dichloronitrobenzene, it was evaluated for its toxic nature upon its acute oral administration in rats. The acute oral LD50 for the test material Benzene, 1, 4-Dichloro-2-Nitro is found to be 2503 mg/Kg. According to the CLP classification, the test material does not classify as an acute oral toxicant.

Thus, based on the above summarised studies on test chemical, it can be concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.

 

Acute inhalation toxicity

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.005 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.

 

Acute dermal toxicity

Various experimental studies of the test chemical were reviewed for acute dermal toxicity endpoint which are summarised as below:

 

In an experimental key study from authoritative database, acute dermal toxicity test was performed to evaluate lethality of test chemical 2,5-Dichloronitrobenzene.The animals were exposed by dermal route with dose concentration of 2000 mg/kg. The animal only showed only a decrease of their spontaneous activity.2000 mg/kg did not lead to any deaths for rats. The LD50 value was found to be >2000 mg/kg in rats exposed to chemical 2,5-Dichloronitrobenzene in acute dermal test.

 

For the test chemical, 2, 5-Dichloronitrobenzene was evaluated for its toxic nature upon its acute dermal application in rats (secondary source). The acute dermal LD50 for the test material Benzene, 1, 4-Dichloro-2-Nitro is found to be >2000 mg/Kg. According to the CLP classification, the test material does not classify as an acute dermal toxicant.

 

The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies for the test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity and LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this range and value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity and cannot be classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.