N,N-dimethylaniline

Endpoint summary

Description of key information

Acute toxicity oral

The acute toxicity by oral route was examined on 5 non-fasted, male Carworth-Wistar rats by gastric intubation. In this study, lethal dose (LD50) concentration was found to be 1348 mg/kg.

Acute toxicity: inhalation

Lowest lethal concentration (LCLo) by inhalation route of N,N-dimethylaniline to rat was found to be 250 mg/m3 indicating that the chemical is moderately toxic.

Acute toxicity: dermal

The acute toxicity by dermal route was examined on the groups of 4 male New Zealand rabbits. All animals were tested using a technique similar to the Draize method. The dose was placed on clipped skin and retained beneath an impervious plastic film for 24 hours. The lethal dose (LD50) of N,N-dimethylaniline (LD50) was found to be 1692 mg/kg body weight.

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)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Compound was administered by gastric intubation to groups of 5 non-fasted, male Carworth-Wistar rats, 90 to 120 gm weight. The LD50 value was determined using Thompson method.

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

other: Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

weight: 90 to 120 gm

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Compound was administered by gastric intubation to groups of 5 non-fasted, male Carworth-Wistar rats, 90 to 120 gm weight. The LD50 value was determined using Thompson method.

Doses:

no data

No. of animals per sex per dose:

5

Control animals:

not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

1 348 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Other details not available

Mortality:

The LD50 value was reported as 1.41 mL/kg, and was determined using Thompson method. (Conversion of 1.41 mL/kg to mg/kg using specific gravity of 0.956 at 20/4°C). No fiducial range was calculated since no dose resulted in partial mortality.

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute toxicity by oral route was examined on 5 non-fasted, male Carworth-Wistar rats by gastric intubation. In this study, lethal dose (LD50) concentration was found to be 1348 mg/kg.

Executive summary:

The acute toxicity by oral route was examined on 5 non-fasted, male Carworth-Wistar rats by gastric intubation. In this study, lethal dose (LD50) concentration was found to be 1348 mg/kg. This value indicates that, N,N-dimethylaniline exhibits acute toxicity by the oral route and will be classified as Acute oral category 4.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 348 mg/kg bw

Quality of whole database:

The data is of K2 level

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:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Standard acute method

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

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

Concentrations:

not reported

No. of animals per sex per dose:

not reported

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LCLo

Effect level:

250 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Other details not available

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Lowest lethal concentration (LCLo) of N,N-dimethylaniline to rat by inhalation route was found to be 250 mg/m³ indicating that the chemical is moderately toxic.

Executive summary:

Lowest lethal concentration (LCLo) of N,N-dimethylaniline to rat by inhalation route was found to be 250 mg/m³ indicating that the chemical is moderately toxic.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Value:

250 mg/m³ air

Quality of whole database:

The data is of K2 level

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)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Groups of 4 male New Zealand rabbits (weight 2.5 to 3.5 kg) were tested using a technique similar to the Draize method. The dose was placed on clipped skin and retained beneath an impervious plastic film for 24 hours.

GLP compliance:

not specified

Test type:

other: technique similar to the Draize method.

Species:

rabbit

Strain:

other: New Zealand

Sex:

male

Details on test animals or test system and environmental conditions:

New Zealand rabbits (weight 2.5 to 3.5 kg)

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

Groups of 4 male albino New Zealand rabbits (weight 2.5 to 3.5 kg) were tested using a technique similar to the Draize method. The dose was placed on clipped skin and retained beneath an impervious plastic film for 24 hours.

Duration of exposure:

24 hrs.

Doses:

no data

No. of animals per sex per dose:

4

Control animals:

not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

1 692 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Other details not available

Mortality:

The LD50 was reported as 1.77 mL/kg, with a standard deviation range of 1.09 to 2.86 mL/kg.
Conversion to mg/kg used the specific gravity of 0.956 at 20/4°C.

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute toxicity by dermal route was examined on the groups of 4 male New Zealand rabbits. All animals were tested using a technique similar to the Draize method. The dose was placed on clipped skin and retained beneath an impervious plastic film for 24 hours. In this study, lethal dose (LD50) concentration was found to be 1692 mg/kg.

Executive summary:

The acute toxicity by dermal route was examined on the groups of 4 male New Zealand rabbits. All animals were tested using a technique similar to the Draize method. The dose was placed on clipped skin and retained beneath an impervious plastic film for 24 hours.

The lethal dose (LD50) was found to be 1.77 mL/kg, with a standard deviation range of 1.09 to 2.86 mL/kg. Conversion to mg/kg used the specific gravity of 0.956 at 20/4°C.

Hence, Dermal toxicity of N,N-dimethylaniline (LD50) was found to be 1692 mg/kg body weight. This value indicates that N,N-dimethylaniline is classified as category IV for acute toxicity through dermal route.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 692 mg/kg bw

Quality of whole database:

The data is of K2 level

Additional information

Acute toxicity: Oral

Based on studies of target substance N,N-dimethylaniline reviewed for acute oral toxicity from reliable sources having Klimisch rating 1, 2 and 4 considering the weight of evidence approach. The summary of the results are presented below

Sr. No	End point	Value	Species	Remark
1.	LD50	1348 mg/kg bw	Rat	Publication
2.	LD50	1410 mg/kg bw	Rat	Publication
3.	LD50	951 mg/kg bw	Rat	RTECS

Based on above table, the endpoint value was found to vary between LD50 =951mg/kg bw to1410mg/kg bw .Considering the CLP criteria for classification of substance it is concluded that N,N-dimethylaniline will show toxicity via oral route and classified in acute toxicity 4 category.

Acute toxicity: inhalation

Based on studies of target substance N,N-dimethylaniline reviewed for acute oral toxicity from reliable sources having Klimisch rating 2 and 4 considering the weight of evidence approach. The summary of the results are presented below 

Sr. No	End point	Value	Species	Remark
1.	LC50	34.299674988 mg/L air	Mouse	QSAR Prediction
2.	LC50	46.786670685 mg/L air	Rat	QSAR Prediction
3.	LCLo	250 mg/m³ air	Rat	Publication
4.	LCLo	980 mg/m³ air	Guinea pig	Publication

 

Based on the above values it can be concluded thatN,N-dimethylanilineis not toxic in nature based on the CLP criteria. But since substance has the harmonized classification for acute toxicity, thus can be considered as toxic vial inhalation route to proceed with the harmonized classification.

Acute toxicity: dermal

The acute toxicity by dermal route was examined on the groups of 4 male New Zealand rabbits. All animals were tested using a technique similar to the Draize method. The dose was placed on clipped skin and retained beneath an impervious plastic film for 24 hours.

The lethal dose (LD50) of N,N-dimethylaniline (LD50) was found to be 1692 mg/kg body weight. This value indicates that N,N-dimethylaniline is classified as category 4 for acute toxicity through dermal route.The above value is also supported by publication data in which the LD50 value of N,N-dimethylaniline in rabbit was found to be 1770 mg/kg.

Justification for selection of acute toxicity – oral endpoint

The acute toxicity by oral route was examined on 5 non-fasted, male Carworth-Wistar rats by gastric intubation. In this study, lethal dose (LD50) concentration was found to be 1348 mg/kg.

Justification for selection of acute toxicity – inhalation endpoint

Lowest lethal concentration (LCLo) by inhalation route of N,N-dimethylaniline to rat was found to be 250 mg/m3 indicating that the chemical is moderately toxic.

Justification for selection of acute toxicity – dermal endpoint

The acute toxicity by dermal route was examined on the groups of 4 male New Zealand rabbits. In this study, the dermal toxicity of N,N-dimethylaniline (LD50) was found to be 1692 mg/kg body weight. This value indicates that N,N-dimethylaniline is classified as category IV for acute toxicity through dermal route.

Justification for classification or non-classification

All the values for the route study indicate that the substance N,N-dimethylaniline will qualify for the classification category of Acute tox 4, but since the substance have harmonised classification the same has not been considered for self classification of N,N-dimethylaniline.and would like to go ahead with the harmonized classification.