N,N-diethylaniline

Endpoint summary

Description of key information

Acute oral toxicity: 

 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. 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 for acute oral toxicity class IV.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats and mice for the test chemical. The LC50 value is between 500-2500 ppm, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute inhalation toxicity class III.

 

Acute Dermal toxicity:

 

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is between 200-1000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute dermal toxicity class III.

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 of test chemical in rats

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

not reported

Doses:

782 mg/kg bw

No. of animals per sex per dose:

not reported

Control animals:

not specified

Details on study design:

not reported

Statistics:

not reported

Preliminary study:

not reported

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

782 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

50% mortality observed

Mortality:

50% mortality observed at 782 mg/kg bw dose

Clinical signs:

other: not reported

Gross pathology:

not reported

Other findings:

not reported

Interpretation of results:

Toxicity Category IV

Conclusions:

The Lethal concentration value for 50 percent mortality (LD 50) in rats by the oral administration of test chemical was reported to be 782 mg/kg body weight.

Executive summary:

Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 782 mg/kg bw. The test chemical was administered via oral unspeciified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. 50% mortality was observed at 782 mg/kg bw. Therefore, LD50 value was considered to be 782 mg/kg bw, when rats were treated with test chemical via oral route..

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

782 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

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from publication

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute inhalation toxicity of test chemical in mice

GLP compliance:

not specified

Test type:

fixed concentration procedure

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

Not available

Route of administration:

inhalation

Type of inhalation exposure:

head only

Vehicle:

not specified

Details on inhalation exposure:

Details not available

Duration of exposure:

4 h

Concentrations:

533ppm, 644 ppm, 782 ppm, and 923 ppm

No. of animals per sex per dose:

10 male rats each dose.

Control animals:

not specified

Details on study design:

Not specified

Statistics:

Not specified

Sex:

male

Dose descriptor:

LC50

Effect level:

4.14 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: 679 ppm equal to 4144.538 mg/m3

Mortality:

533 ppm (2/10), 644 ppm (6/10), 782ppm (5/10), AND 923ppm (9/10).

Clinical signs:

other: CLINICAL SIGNS DURING AND IMMEDIATELY AFTER EXPOSURE INCLUDED: CYANOSIS, TREMORS, SEMIPROSTRATION, REDDISHBROWN NASAL DISCHARGE, HIND IMB ATAXIA, SALIVATION, AND ABNORMAL ARCHED BACK POSTURE. SIGNS OBSERVED AFTER 24 HOURS INCLUDED: STAINED PERINEAL AREA,

Body weight:

WEIGHT LOSS WAS OBSERVED 13 DAYS AFTER EXPOSURE; THEREAFTER NORMAL WEIGHT GAIN WAS SEEN.

Gross pathology:

Not specified

Other findings:

Not specified

Interpretation of results:

Toxicity Category III

Conclusions:

Acute inhalation toxicity in male rats was reported to be 679 ppm(4144.538 mg/m3 =4.144 mg/L).

Executive summary:

Acute inhalation toxicity for test chemical was studied in male rats. male rats(head only) were exposed for a single 4 hour period at a concentration of 533ppm, 644 ppm, 782 ppm, and 923 ppm. Clinical signs during and immediately after exposure included cyanosis, tremors, semi prostration, reddish brown nasal discharge, hind limb ataxia, salivation, and abnormal arched back posture. Signs observed after 24 hours included: stained perineal area, pallor, and reddish brown nasal discharge. Thus, LC 50 value was reported to be 679 ppm(4144.538 mg/m3=4.144 mg/l)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

4 144.43 mg/m³ air

Quality of whole database:

Data is Klimisch 2 and from authoritative database

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)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from secondary source

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute dermal toxicity of test chemical in rabbits

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

not specified

Duration of exposure:

Exposure period unspecified

Doses:

468 and 935 mg/kg-bw

No. of animals per sex per dose:

4/dose

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Sex:

not specified

Dose descriptor:

LD0

Effect level:

468 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality

Sex:

not specified

Dose descriptor:

LD100

Effect level:

935 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 100 % mortality

Mortality:

No mortalities occurred at 468 mg/kg-bw and all animals died at 935 mg/kg-bw.

Clinical signs:

other: not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Toxicity Category III

Conclusions:

The acute dermal LD50 value was considered to be <935 mg/kg bw when rabbits were treated with test chemical via dermal route.

Executive summary:

Acute dermal toxicity study test chemicalwas conducted on rabbits at the dose concentration of 468 and 935 mg/kg bw. The test chemical was administered via dermal route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days.No mortalities were observed at 468 mg/kg-bw and all animals died at 935 mg/kg-bw. Thus the Lethal dose, 50 percent kill value (LD50) of test chemical for dermal toxicity in rabbit in between 468 and 935 mg/kg bw. This value suggests that test chemical is toxic by the dermal route and will be classified in category 3 for acute dermal toxicity. (LD0 is used for classification instead of LD50)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

935 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from authoritative database

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

 

1 Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 782 mg/kg bw. The test chemical was administered via oral unspecified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. 50% mortality was observed at 782 mg/kg bw. Therefore, LD50 value was considered to be 782 mg/kg bw, when rats were treated with test chemical via oral route.

 

2. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 720 mg/kg bw. The test chemical was administered via oral unspecified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Therefore, LD50 value was considered to be 720 mg/kg bw, when rats were treated with test chemical via oral route.

 

3. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 100, 500, 600, 700 and 800 mg/kg-bw mg/kg bw. The test chemical was administered via oral gavage route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. There were no mortalities at 100 mg/kg-bw, one at 500 mg/kg-bw, two at 600 mg/kg-bw and six at 700 mg/kg-bw; all animals died at 800 mg/kg-bw. Clinical signs like Cyanosis, palmospasms, disorders of balance, increased diuresis, impaired general condition were observed. Therefore, LD50 value was considered to be 606 mg/kg bw, when rats were treated with test chemical via oral route.

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

 

Acute Inhalation Toxicity:

In different studies, the given test chemical has been investigated for acute inhalation toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below – 

1. Acute inhalation toxicity for test chemical was studied in male rats. male rats(head only) were exposed for a single 4 hour period at a concentration of 533ppm, 644 ppm, 782 ppm, and 923 ppm. Clinical signs during and immediately after exposure included cyanosis, tremors, semi prostration, reddish brown nasal discharge, hind limb ataxia, salivation, and abnormal arched back posture. Signs observed after 24 hours included: stained perineal area, pallor, and reddish brown nasal discharge. Thus, LC 50 value was reported to be 679 ppm(4144.538 mg/m3=4.144 mg/l)

2. The Lethal concentration, 50 percent mortality value (LC50) of test chemical for inhalation toxicity in rat was reported as 1.92 mg/L in a four hour exposure. This value suggests that test chemical is toxic by the inhalation route and will be classified in category 2 for acute inhalation toxicity.

3. The acute LC50 of test chemical was 4.3 mg/L. when based on nominal chamber concentration and 1.92 mg/L when based on average actual chamber concentration. The upper and lower 95% confidence intervals were 4.8 mg/L to 3.7 mg/L (nominal) and 2.10 mg/L to 1.84 mg/L (actu.al), respectively. Daily observations indicated the presence of ataxia and tremors in animals exposed to nominal concentrations of 5.2 mg/L or greater of test article. In addition, at this concentration, nasal discharge and decreased body weights were evident post exposure. Thus, LC50 value was considered to be 1920 mg/L bw, when rats were treated with test chemical.

Thus, based on the above summarized studies on test chemical, it can be concluded that LC50 value is between 500-2500 ppm. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute inhalation toxicity class III.

 

Acute Dermal Toxicity:

 

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below –

 

1 Acute dermal toxicity study test chemicalwas conducted on rabbits at the dose concentration of 468 and 935 mg/kg bw. The test chemical was administered via dermal route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days.No mortalities were observed at 468 mg/kg-bw and all animals died at 935 mg/kg-bw. Thus the Lethal dose, 50 percent kill value (LD50) of test chemical for dermal toxicity in rabbit in between 468 and 935 mg/kg bw. This value suggests that test chemical is toxic by the dermal route and will be classified in category 3 for acute dermal toxicity. (LD0 is used for classification instead of LD50)

 

2. Acute dermal toxicity study oftest chemicalwas conducted on rabbits at the dose concentration of >5000 mg/kg bw. The test chemical was administered via dermal route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical via dermal route.

 

3. Acute dermal toxicity study of test chemical was conducted on rabbits at the dose concentration of >400 mg/kg bw. The test chemical was administered via dermal route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days.Therefore, LD50 value was considered to be >400 mg/kg bw, when rabbits were treated with test chemical via dermal route.

4. Acute dermal toxicity study of test chemical was conducted on 4 groups of male and female New Zealand white rabbits at the dose concentration of 100, 215 464 and 1000 mg/kg bw. The test chemical was administered occlusive. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Mortality was observed at a dose level of 215, 464 and 1000 mg/kg bw. Body weight changes were observed and systemic toxicity signs like excessive salivation, eyes exceptionally blue and partially closed, depression, diarrhea, nasal discharge were observed during 14 days observation period. Gross necropsy signs like externally, a sac-like protrusion in the genital area were observed. Therefore, LD50 value was considered to be 464 mg/kg bw, when rabbits were treated with test chemical via dermal route

 

Thus, based on the above summarized studies on test chemical, it can be concluded that LD50 value is between 200-1000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute dermal toxicity class III.

Justification for classification or non-classification

Based upon the LD50 and LC50 values of test chemical it is observed that the chemical is classified in the following category; Acute oral (category 4), acute inhalation (category 3) and acute dermal (category 3). However, since test chemical has a harmonized classification within the CLP regulation of Acute toxicity category 3 (oral, inhalation and dermal) the same classification shall be adhered to in the classification and labeling section of this dossier.