N,N-dimethyl-p-toluidine

Endpoint summary

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the given test chemical. The LD50 value is 1650 mg/kg bw. The study 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 dose (LC50) was considered based on study conducted on rats for the given test chemical. The LC50 value is 1400 mg/m3 (1.4 mg/L). The study concluded that the LC50 value is between 1.0-5.0 mg/L, for acute inhalation toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 2” for acute inhalation toxicity.

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on study conducted on rabbts for the test chemical. 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:

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:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity study of the given test chemical was performed in rat.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: fasting was done

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not specified

Doses:

1250, 1800 and 2500 mg/kg bw

No. of animals per sex per dose:

groups of five male and five female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: The rats were observed for 14 days after test substance administration.
- Other examinations performed: Animals were observed for mortality and clinical signs.

Statistics:

not specified

Preliminary study:

not specified

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 300 mg/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 950 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 650 mg/kg bw

Based on:

test mat.

Mortality:

Mortality occurred on days 2 to 3 in 1/5, 5/5, and 5/5 male rats and in 1/5, 0/5, and 5/5 female rats dosed at 1250, 1800, and 2500 mg/kg, respectively.

Clinical signs:

other: other: other: Decreased activity (slight to moderate) was observed up to test day 9 in 7 rats dosed at 1250 mg/kg, in 6 rats dosed at 1800 mg/kg, and in 8 rats dosed at 2500 mg/kg. Decreased activity (extreme) was observed up to test day 2 in 2 rats dosed

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Acute oral toxicity dose (LD50) value was considered to be 1300 mg/kg in male rats, 1950 mg/kg in female rats and 1650 mg/kg in male and female rats combined.

Executive summary:

Acute oral toxicity study was conducted for the test chemical as per OECD 401. The test chemical was dosed via gavage to groups of five male and five female Sprague-Dawley rats at the test concentration of 1250, 1800 and 2500 mg/kg bw. The rats were observed for 14 days after test chemical administration for mortality and clinical signs. Mortality occurred on days 2 to 3 in 1/5, 5/5, and 5/5 male rats and in 1/5, 0/5, and 5/5 female rats dosed at 1250, 1800, and 2500 mg/kg, respectively. Decreased activity (slight to moderate) was observed up to test day 9 in 7 rats dosed at 1250 mg/kg, in 6 rats dosed at 1800 mg/kg, and in 8 rats dosed at 2500 mg/kg. Decreased activity (extreme) was observed up to test day 2 in 2 rats dosed at 1250 mg/kg and in 3 rats dosed at 2500 mg/kg. Hunched posture was observed on test days 5-8 in one rat dosed at 1800 mg/kg. Salivation (slight to moderate) was observed the day after dosing in one rat dosed at 2500 mg/kg.Under the conditions of the study, the acute oral toxicity dose (LD50) value was considered to be 1300 mg/kg in male rats, 1950 mg/kg in female rats and 1650 mg/kg in male and female rats combined.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 650 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:

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 databases

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute inhalation toxicity study of the test chemical was performed in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animals for this study were received in two shipments. Animals from the first shipment were used for the first three exposures and those from the second shipment were used for the fourth exposure.
- Age at study initiation: At arrival, the rats were approximately 36-43 days of age. The rats were approximately 43-58 days of age at exposure.
- Weight at study initiation: The body weight ranges at arrival were 121-158 g for male rats and 124-143 g for female rats from the first shipment and 130-156 g for male rats and 126-160 g for female rats from the second shipment.
- Housing: During the quarantine, exposure, and post-exposure observation periods, the rats were housed individually in stainless steel cages (18.4 x 16.5 x 15.9 cm).
- Diet (e.g. ad libitum): The NIH-07 open formula pellet diet, ad libitum
- Water (e.g. ad libitum): Water from an automatic watering system, ad libitum
- Acclimation period: The animals were held in quarantine for at least one week before use.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-25°C
- Humidity (%):28-63%RH
- Photoperiod (hrs dark / hrs light): Fluroscent lighting was provided automatically on a 12 hours light : 12 hours dark schedule.

Route of administration:

inhalation: mixture of vapour and aerosol / mist

Type of inhalation exposure:

whole body

Vehicle:

not specified

Mass median aerodynamic diameter (MMAD):

> 0.23 - <= 0.57 µm

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass Rochester-type inhalation exposure chamber
- Exposure chamber volume: 500 liter
- Source and rate of air: Conditioned room air, which was passed through coarse and HEPA filters before entering the exposure chamber, was used as supply air.
- Method of conditioning air: The air was passed through coarse and HEPA filters.
- System of generating particulates/aerosols: Test atmospheres of the chemical were generated by aerosolizing the test substance and approximately diluting the aerosols with filtered air. Test chemical aerosols were generated by a stainless-steel aspirator device (Laskin type) for the two higher exposure concentrations (5.27 and 1.73mg/l} and a modified commercial nebulizer (DeVilbiss, Mode! 40, Somerset, PA) for the two lower exposure concentrations (0.99 and 0.30 mg/l).
The Laskin fixture consisted of 1/4-inch diameter stainless-steel tube with two to four orifices spaced evenly around the periphery. At each orifice & 1/16-inch diameter stainless-steel aspirator tube was attached for delivery of the test substance. The test material was delivered from 3 reservoirs to the aspirator (by head pressure and suction) through Teflon tubing and a manifold equipped with a metering valve. The output of the generator was directed against an impaction surface to remove coarse particles and control particle size. Aerosol concentration was maintained at a constant level by adjusting air pressure to the aspirator and delivery rate of the test material.
- Method of particle size determination: Aerosol particle size was monitored with a Guartz Crystal Microbalance cascade impactor (California Measurements, inc., Sierra Madre, CA).
- Treatment of exhaust air: Chamber exhaust was passed through a HEPA filter.
- Temperature, humidity, pressure in air chamber: Chamber temperature and relative humidity were monitored with an electronic thermo hygrometer. The chamber airflow rate was monitored continuously with a Calibrated differential pressure gauge. Chamber temperature, relative humidity and airflow rate were recorded at approximately 30 min. intervals during tie exposures. The chamber oxygen concentration was Measured at least three times during the exposures using a Lynn Model 6200 or servomex Series 1490 oxygen analyzer.

TEST ATMOSPHERE
- Brief description of analytical method used: The sampling train consisted of a pre-weighed filter in series with two mini impingers filled with isopropyl alcohol connected to a constant flow vacuum pump. The filter and impinger samples were analyzed by a gas chromatographic method provided by the Sponsor and modified by quantitatively determine the amount of test substance. A dry-gas meter connected to the positive pressure side of the pump was used to record the corresponding volume of chamber air sampled and the weight to volume ratio was determined. In addition appropriate real-time sensors (aerosol sensor for the two high exposure levels and an infrared vapor sensor for the two low exposure levels) were used to monitor exposure concentrations. These sensors were used only as continuous indicators of short term changes In exposure concentration to guide laboratory personnel in correcting concentration excursions.
- Samples taken from breathing zone: yes, Mass concentration of test chemical in the breathing zone of the rats was determined chemically by analyzing filter samples (aerosol phase collection) and impinger samples (vapor phase collection) collected once each hour during the exposure.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.27, 1.73, 0.99, and 0.30 mg/l.

No. of animals per sex per dose:

four treatment groups of five male and five female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed carefully for signs af toxicity immediately after removal from the exposure chamber and at least once per day during the 14-day observation period. To the maximum extent possible, animals were also observed during the exposures. During the two highest concentration exposures, most or all rats could not be adequately observed to allow any documentation of clinical signs.
Body Weights: All test rats were weighed immediately before exposure, on post-exposure day 7 and just before necropsy.
- Necropsy of survivors performed: yes, All test animals found dead were subjected to gross necropsy. At the end of the 14-day observation period, all surviving rats were euthanized following an intraperitoneal injection of sodium pentobarbital or CO2 asphyxiation (by exsanguination) and subjected to gross necropsy. The necropsy included examination of all body surfaces and openings and of the external surface of the brain, heart, lungs end respiratory tract, liver, Spleen, kidneys, adrenals, gastrointestinal tract, gonads and urinary bladder. The gastrointestinal tract and urinary bladder were opened and examined if lesions were observed.

Statistics:

not specified

Preliminary study:

Animals were initially exposed to a target concentration of 5 mg/I. Target concentrations for the three subsequent exposures were selected based on mortality due to this initial
exposure end the results of each subsequent exposure.

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1.4 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

Mortality occurred as – At 5.27 mg/l – All animals found dead;
At 1.73 mg/l – 3 males and 5 females found dead and no mortality was observed at 0.30 and 0.99 mg/l.

Clinical signs:

other:

Body weight:

For the 5.27, 1.73, 0.99 and 0.30 mg/! exposure groups, MEAN pre-exposure body weights ranged from 137 to 262 g for male rats and 169 to 1392 g for female rats.
For male survivors of exposure to 1.72 mg/l and male and female Survivors of exposure to 0.99 or 0.20 mg/l (all rats), weight gain was observed during both the first and second weeks of the observation period. Mean cumulative weight gain ranged from 73 to 91 g for male rats and 28 to 33 g for female rats.

Gross pathology:

No gross lesions were found in animals exposed to 0.99 or 0.30 mg/l. In rats exposed to the two higher concentrations, mottled lungs and red ovaries were frequently found and may have been exposure-related. Several rats from these groups also had gas-filled gastrointestinal organs. A few other lesions were observed in individual rats, but were not considered to be toxicologically significant.

Other findings:

not specified

Interpretation of results:

Category 2 based on GHS criteria

Conclusions:

Acute inhalation toxicity dose (LC50) value was considered to be 1.4 mg/L (1400 mg/m3), when 40 male and female Sprague-Dawley rats were treated with the given test chemical via inhalation route to whole-body exposure by aerosol/vapor for 4-h period.

Executive summary:

Acute inhalation toxicity study was conducted by using the given test chemical in 40 Sprague-Dawley rats at the doses of 5.27, 1.73, 0.99, and 0.30 mg/l via inhalation route to whole-body exposure by aerosol/vapor for 4-h period. Animals were initially exposed to a target concentration of 5 mg/I. Test concentrations for the three subsequent exposures were selected based on mortality due to this initial exposure end the results of each subsequent exposure.All rats were observed carefully for signs af toxicity immediately after removal from the exposure chamber and at least once per day during the 14-day observation period. To the maximum extent possible, animals were also observed during the exposures. During the two highest concentration exposures, most or all rats could not be adequately observed to allow any documentation of clinical signs.All test rats were weighed immediately before exposure, on post-exposure day 7 and just before necropsy. All test animals found dead were subjected to gross necropsy. At the end of the 14-day observation period, all surviving rats were euthanized following an intraperitoneal injection of sodium pentobarbital or CO2 asphyxiation (by exsanguination) and subjected to gross necropsy. The necropsy included examination of all body surfaces and openings and of the external surface of the brain, heart, lungs end respiratory tract, liver, Spleen, kidneys, adrenals, gastrointestinal tract, gonads and urinary bladder. The gastrointestinal tract and urinary bladder were opened and examined if lesions were observed. Mortality occurred as – At 5.27 mg/l – All animals found dead; At 1.73 mg/l – 3 males and 5 females found dead and no mortality was observed at 0.30 and 0.99 mg/l.Clinical signs in rats exposed to 1.73 mg/l included hypo activity, a comatose / prostrate condition, dyspnea or rapid respiration and salivation. Other incidental signs observed for some animals from this group included urine stains, eye discharge, ptosis, limb paralysis, nasal discharge, red material around the nose and red material around the eyes. The most frequently observed signs in rats exposed to 0.99 or 0.30 mg/l were nasal discharge and red material around the nose. Two male rats and one female rat from the 0.30 mg/l group were also reported to have dyspnea immediately after the exposure. Rats exposed to one of the two lower concentrations were free of signs by 1-2 days post-exposure.For the 5.27, 1.73, 0.99 and 0.30 mg/! exposure groups, MEAN pre-exposure body weights ranged from 137 to 262 g for male rats and 169 to 1392 g for female rats.

For male survivors of exposure to 1.72 mg/l and male and female Survivors of exposure to 0.99 or 0.20 mg/l (all rats), weight gain was observed during both the first and second weeks of the observation period. Mean cumulative weight gain ranged from 73 to 91 g for male rats and 28 to 33 g for female rats. No gross lesions were found in animals exposed to 0.99 or 0.30 mg/l. In rats exposed to the two higher concentrations, mottled lungs and red ovaries were frequently found and may have been exposure-related. Several rats from these groups also had gas-filled gastrointestinal organs. A few other lesions were observed in individual rats, but were not considered to be toxicologically significant. Under the condition of the study, the LC50 value was considered to be 1.4 mg/L (1400 mg/m3), when 40 male and female Sprague-Dawley rats were treated with the given test chemical via inhalation route to whole-body exposure by aerosol/vapor for 4-h period.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

1 400 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:

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 databases.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Acute dermal toxicity study of the given test chemical was performed in rabbit.

GLP compliance:

not specified

Test type:

other: Acute Dermal Toxicity

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

not specified

Duration of exposure:

not specified

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Preliminary study:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at 2000 mg/kg bw

Clinical signs:

other: other: other: not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

Acute dermal toxicity dose (LD50) value was considered to be >2000 mg/kg bw, when 10 male and five female New Zealand White rabbits were treated with the given test chemical by dermal route.

Executive summary:

Acute dermal toxicity study was conducted as per OECD 402 by using the test chemical in 10 male and five female New Zealand White rabbits at the test concentration of 2000 mg/kg bw by dermal route. Animals were observed for mortality. No mortality was observed at 2000 mg/kg bw.Hence, the LD50 value was considered to be >2000 mg/kg bw, when 10 male and five female New Zealand White rabbits were treated with the test chemical by dermal route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from authoritative database.

Additional information

Acute oral toxicity:

In different studies, the 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 and mice for test chemical. The studies are summarized as below –

Acute oral toxicity study was conducted for the test chemical as per OECD 401. The test chemical was dosed via gavage to groups of five male and five female Sprague-Dawley rats at the test concentration of 1250, 1800 and 2500 mg/kg bw. The rats were observed for 14 days after test chemical administration for mortality and clinical signs. Mortality occurred on days 2 to 3 in 1/5, 5/5, and 5/5 male rats and in 1/5, 0/5, and 5/5 female rats dosed at 1250, 1800, and 2500 mg/kg, respectively. Decreased activity (slight to moderate) was observed up to test day 9 in 7 rats dosed at 1250 mg/kg, in 6 rats dosed at 1800 mg/kg, and in 8 rats dosed at 2500 mg/kg. Decreased activity (extreme) was observed up to test day 2 in 2 rats dosed at 1250 mg/kg and in 3 rats dosed at 2500 mg/kg. Hunched posture was observed on test days 5-8 in one rat dosed at 1800 mg/kg. Salivation (slight to moderate) was observed the day after dosing in one rat dosed at 2500 mg/kg. Under the conditions of the study, the acute oral toxicity dose (LD50) value was considered to be 1300 mg/kg in male rats, 1950 mg/kg in female rats and 1650 mg/kg in male and female rats combined.

This result is supported by another study where the test chemical was dosed at concentration of 980 mg/kg via oral routes to rats to evaluate the toxic potential of the test chemical. The rats were observed for mortality.50% mortality was observed at 980 mg/kg bw. Hence, the acute oral toxicity dose (LD50) value was considered to be 980 mg/kg bw, when rats were treated with the test chemical via oral route.

These results are further supported by a single dose oral toxicity study conducted in mice to evaluate the toxic nature of the test chemical . Mice were dosed with 139 mg/kgbw of the test chemical via oral route. The treated mice were observed for mortality.50% mortality was observed at 139 mg/kg bw. Hence, the acute oral toxicity dose (LD50) value was considered to be 139 mg/kg bw, when mice were treated with the given test chemical via oral route.

Based upon the study results and available information, the test substance is expected to show acute toxicity effect by the oral route and thus will be considered for further classification. Hence, the test chemical is classified under the category "Category 4" as per CLP Regulation.

Acute Inhalation Toxicity:

Acute inhalation toxicity study was conducted by using the given test chemical in 40 Sprague-Dawley rats at the doses of 5.27, 1.73, 0.99, and 0.30 mg/l via inhalation route to whole-body exposure by aerosol/vapour for 4-h period. Animals were initially exposed to a target concentration of 5 mg/I. Test concentrations for the three subsequent exposures were selected based on mortality due to this initial exposure end the results of each subsequent exposure. All rats were observed carefully for signs of toxicity immediately after removal from the exposure chamber and at least once per day during the 14-day observation period. To the maximum extent possible, animals were also observed during the exposures. During the two highest concentration exposures, most or all rats could not be adequately observed to allow any documentation of clinical signs. All test rats were weighed immediately before exposure, on post-exposure day 7 and just before necropsy. All test animals found dead were subjected to gross necropsy. At the end of the 14-day observation period, all surviving rats were euthanized following an intraperitoneal injection of sodium pentobarbital or CO2 asphyxiation (by exsanguination) and subjected to gross necropsy. The necropsy included examination of all body surfaces and openings and of the external surface of the brain, heart, lungs end respiratory tract, liver, Spleen, kidneys, adrenals, gastrointestinal tract, gonads and urinary bladder. The gastrointestinal tract and urinary bladder were opened and examined if lesions were observed. Mortality occurred as – At 5.27 mg/l – All animals found dead; At 1.73 mg/l – 3 males and 5 females found dead and no mortality was observed at 0.30 and 0.99 mg/l. Clinical signs in rats exposed to 1.73 mg/l included hypo activity, a comatose / prostrate condition, dyspnea or rapid respiration and salivation. Other incidental signs observed for some animals from this group included urine stains, eye discharge, ptosis, limb paralysis, nasal discharge, red material around the nose and red material around the eyes. The most frequently observed signs in rats exposed to 0.99 or 0.30 mg/l were nasal discharge and red material around the nose. Two male rats and one female rat from the 0.30 mg/l group were also reported to have dyspnea immediately after the exposure. Rats exposed to one of the two lower concentrations were free of signs by 1-2 days post-exposure. For the 5.27, 1.73, 0.99 and 0.30 mg/! exposure groups, MEAN pre-exposure body weights ranged from 137 to 262 g for male rats and 169 to 1392 g for female rats. For male survivors of exposure to 1.72 mg/l and male and female survivors of exposure to 0.99 or 0.20 mg/l (all rats), weight gain was observed during both the first and second weeks of the observation period. Mean cumulative weight gain ranged from 73 to 91 g for male rats and 28 to 33 g for female rats. No gross lesions were found in animals exposed to 0.99 or 0.30 mg/l. In rats exposed to the two higher concentrations, mottled lungs and red ovaries were frequently found and may have been exposure-related. Several rats from these groups also had gas-filled gastrointestinal organs. A few other lesions were observed in individual rats, but were not considered to be toxicologically significant. Under the condition of the study, the LC50 value was considered to be 1.4 mg/L (1400 mg/m3), when 40 male and female Sprague-Dawley rats were treated with the test chemical via inhalation route to whole-body exposure by aerosol/vapor for 4-h period.

Based upon the study results and available information, the test substance is expected to show acute toxicity effect by the inhalation route and thus will be considered for further classification. Hence, the test chemical is classified under the category "Category 2" as per CLP Regulation.

Acute Dermal Toxicity:

The study was conducted to determine acute dermal toxicity dose by using the given test chemical as per OECD 402 in 10 male and five female New Zealand White rabbits at the test concentration of 2000 mg/kg bw by dermal route. Animals were observed for mortality. No mortality was observed at 2000 mg/kg bw. Hence, the LD50 value was considered to be >2000 mg/kg bw, when 10 male and five female New Zealand White rabbits were treated with the test chemical by dermal route.

Based upon the details available for the test chemical, it is likely to classify under the category "Not Classified" for acute dermal toxicity as per CLP Regulation.

Justification for classification or non-classification

Based upon the details available for the test chemical, it is likely to classify under the category "Category 4" for acute oral and "'Category 2" for acute inhalation toxicity and "Not Classified" for acute dermal toxicity, but we are going with the harmonised classification for oral and dermal route, i.z., Category 3 for both acute oral and dermal toxicity.
Henceforth, final classification of the substance is Acute oral Cat. 3 (H301), Acute dermal Cat. 3 (H311) and Acute inhalation Cat. 2 (H330), respectively.