Registration Dossier

Administrative data

Description of key information

Acute Toxicity: Oral

Based on the available studies and applying the weight of evidence approach , the acute oral LD50 value of the test chemical can be considered to lie between 50- 300 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity.

Acute Toxicity: Inhalation

The study need not be conducted because the exposure of the test chemical via inhalation is not likely owing its vapour pressure and/or the possibility of exposure to aerosols, particles or droplets of inhalable size. The estimated vapour pressure of the test chemical was 5.47E-14 mm Hg. Hence, this endpoint was considered for waiver.

Acute Toxicity: Dermal

Based on the available studies and applying the weight of evidence approach , the acute dermal LD50 value of the test chemical can be considered to be greater than 2000 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Not 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
WoE report is based on 3 acute oral toxicity studies as - WoE 2, WoE 3 and WoE 4.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: 2. not specified; 3,4. Sprague Dawley
Sex:
female
Route of administration:
oral: gavage
Vehicle:
other: 2. not specified; 3. PEG 400; 4. 1% aqueous Tween 80
Details on oral exposure:
2. no data available
3.VEHICLE
- Concentration in vehicle: 300 mg/kg, 300 mg/kg, 50 mg/kg and 50 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: 10 ml/kg body weight.

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available

4.3.VEHICLE
- Concentration in vehicle: 300 mg/kg, 300 mg/kg, 50 mg/kg and 50 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: 10 ml/kg body weight.

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Doses:
2. 0- 2000 mg/kgbw
3. 50 and 300 mg/kgbw
4. 50 and 300 mg/kgbw
No. of animals per sex per dose:
2. no data available
3. 9 females
4. 9 females
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
90 mg/kg bw
Based on:
test mat.
Remarks on result:
other: study 2
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - <= 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: study 3
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - <= 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Study 4
Mortality:
2. no data available
3. One animal died at 1 hour, one animal died at 2hoursand 1 animal died at 4 hours after the dosing.
4. One animal died at 4 hours after the dosing.
Clinical signs:
2. no data available
3. Administration of the test item at 50 mg/kg resulted did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed was observed at 24 hours after the dosing, three additional female animals were added to the study and treated with the dose of 50mg/kg of the test item (Step-II). Administration of the test item at 50 mg/kg resulted did not result in any signs of toxicity and mortality at 24 hours after the dosing. Administration of the test item at 300 mg/kg resulted in reduced locomotor activity, ataxic gait and loss of righting reflex with onset at 10minutes to 2 hours after dosing.
4. Administration of the test item at 300 mg/kg resulted in diarrhoea, reduced locomotor activity, ataxic gait and convulsions with onset at 30 minutes to 2 hours after the dosing. (Step - II). Administration of the test item at 300 mg/kg resulted in diarrhoea, reduced locomotor activity, ataxic gait and convulsions with onset at 30 minutes after the dosing. Two animals died at 1 hour after the dosing. As mortality was observed at 300 mg/kg dose group, hence three female animals were treated with the lower dose of 50 mg/kg of the test item (Step - I).Administration of the test item at 50 mg/kg resulted in diarrhoea, piloerection and ataxic gait with onset at 4 to 6 hours after the dosing and no mortality after the dosing.(Step - II). Administration of the test item at 50 mg/kg resulted in diarrhoea and ataxic gait with onset at 4 to 6 hours after the dosing and no mortality after the dosing. All animals from 50 mg/kg dose group survived and exhibited normal body weight gain through the study period of 14 days.
Body weight:
2. no data available
3. no data available
4. All animals from 50 mg/kg dose group survived and exhibited normal body weight gain through the study period of 14 days
Gross pathology:
2. no data available
3. Gross pathological examination test item colored stomach mucosa and intestine with test item colored ingesta in all animals from 300 mg/kg dose group.
Gross pathological examination did not reveal any abnormalities in all animals from 50mg/kg dose group.
4. Gross pathological examination did not reveal any abnormalities in animals sacrificed terminally from 50 mg/kg and 300 mg/kg dose groups. Gross pathological examination revealed stomach, small and large intestine distended with yellowish liquid ingesta in found dead animals from 300 mg/kg dose group.
4.
Other findings:
2. no data available
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Based on the available studies and applying the weight of evidence approach , the acute oral LD50 value of the test chemical can be considered to lie between 50- 300 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity.
Executive summary:

Various studies have been reviewed to determine the exact single dose of the test chemical which is required to kill 50% of the test animals when dosed orally. These include in vivo experimental studies performed on rats for the test chemicals.

The acute oral toxicity study was carried out to ascertain single oral dose of the test chemical which is required to kill 50% of the test animals. Rats were dosed with 0 -2000 mg/kgbw of the test chemical orally and observed for toxic signs till 14 days.The acute oral LD50 in rats was 90 mg/kgbw in rats.

This is supported by the results of OECD 423 Guideline study was designed and conducted to determine the acute oral toxicity profile of the given test chemical in Sprague Dawley rats.

Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in reduced locomotor activity, ataxic gait and loss of righting reflex with onset at 10minutes to 2 hours after dosing. One animal died at 1 hour, one animal died at 2 hours and 1 animal died at 4 hours after the dosing. As mortality was observed at 300mg/kg dose group, additional three female animals were treated with lower dose of 50mg/kg of test chemical (Step - I).

Administration of the test item at 50 mg/kg resulted did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed was observed at 24 hours after the dosing, three additional female animals were added to the study and treated with the dose of 50mg/kg of the test item (Step-II). Administration of the test item at 50 mg/kg resulted did not result in any signs of toxicity and mortality at 24 hours after the dosing. All animals from 50 mg/kg survived through the study period of 14 days. Gross pathological examination test item colored stomach mucosa and intestine with test item colored ingesta in all animals from 300 mg/kg dose group. Gross pathological examination did not reveal any abnormalities in all animals from 50mg/kg dose group.Under the condition of this, the lethal concentration (LD50) value for acute oral toxicity test was considered in between 50-300 mg/kg bw, when female Sprague Dawley rats were treated with the given test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

These results are supported by the another OECD 423 Guideline study designed and conducted to determine the acute oral toxicity profile of the test chemical in Sprague Dawley rats.

Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in diarrhoea, reduced locomotor activity, ataxic gait and convulsions with onset at 30 minutes to 2 hours after the dosing. One animal died at 4 hours after the dosing. As mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg resulted in diarrhoea, reduced locomotor activity, ataxic gait and convulsions with onset at 30 minutes after the dosing. Two animals died at 1 hour after the dosing. As mortality was observed at 300 mg/kg dose group, hence three female animals were treated with the lower dose of 50 mg/kg of the test item (Step - I).Administration of the test item at 50 mg/kg resulted in diarrhoea, piloerection and ataxic gait with onset at 4 to 6 hours after the dosing and no mortality after the dosing. As no mortality was observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 50 mg/kg of the test item (Step - II). Administration of the test item at 50 mg/kg resulted in diarrhoea and ataxic gait with onset at 4 to 6 hours after the dosing and no mortality after the dosing. All animals from 50 mg/kg dose group survived and exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities in animals sacrificed terminally from 50 mg/kg and 300 mg/kg dose groups. Gross pathological examination revealed stomach, small and large intestine distended with yellowish liquid ingesta in found dead animals from 300 mg/kg dose group.

Hence, The lethal concentration (LD50-Cut-off value) value for acute oral toxicity test was considered to be 300 mg/kg bw, when female Sprague Dawley rats were treated with test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Based on the available studies and applying the weight of evidence approach , the acute oral LD50 value of the test chemical can be considered to lie between 50- 300 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw
Quality of whole database:
Klimisch Rating 1

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
14 days
Doses:
2. DRF - 200, 1000, 2000 mg/kgbw; Main study- 2000 mg/kgbw
3. 2000 mg/kgbw
No. of animals per sex per dose:
2. 5 females
3. 5 male and 5 female animals
Control animals:
not specified
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2. As the dose range finding study revealed no mortality or clinical signs at the maximum dose of 2000 mg/kg. Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days.
3. . Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days.
Clinical signs:
2. Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days.
3. . Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days.
Body weight:
2. Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days.
3. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days.
Gross pathology:
2. Gross pathological examination did not reveal any abnormalities attributable to the treatment.
3. Gross pathological examination did not reveal any abnormalities attributable to the treatment.
Interpretation of results:
other: not classified
Conclusions:
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The acute dermal LD50 for the test chemical was estimated to be greater than 2000 mg/kgbw . Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Executive summary:

Various studies have been reviewed to determine the exact single dose of the test chemical which is required to kill 50% of the test animals when dosed dermally. These include in vivo experimental studies performed on rats for the test chemicals.

A study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) in Sprague Dawley rats.

In the dose range finding study a single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered with the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight. Administration of 2000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours.As the dose range finding study revealed no mortality or clinical signs at the maximum dose of 2000 mg/kg, the main study was initiated with two additional animals. The animals were administered with a dose of 2000 mg/kg body weight in sequential manner at 48 hours intervals.Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

This is supported by the results of another OECD 402 Guideline study designed and conducted to evaluate the acute dermal toxicity profile of the test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. Hence, The LD50 value was considered to be >2000 mg/kg bw, when male and female Sprague Dawley rats were semi-occlusively treated with test chemical  by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity). 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value was greater than 2000 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Not Classified” for acute dermal toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Klimisch rating 1

Additional information

Acute Toxicity: Oral

Various studies have been reviewed to determine the exact single dose of the test chemical which is required to kill 50% of the test animals when dosed orally. These include in vivo experimental studies performed on rats for the test chemicals.

The acute oral toxicity study was carried out to ascertain single oral dose of the test chemical which is required to kill 50% of the test animals. Rats were dosed with 0 -2000 mg/kgbw of the test chemical orally and observed for toxic signs till 14 days.The acute oral LD50 in rats was 90 mg/kgbw in rats.

This is supported by the results of OECD 423 Guideline study was designed and conducted to determine the acute oral toxicity profile of the given test chemical in Sprague Dawley rats.

Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in reduced locomotor activity, ataxic gait and loss of righting reflex with onset at 10minutes to 2 hours after dosing. One animal died at 1 hour, one animal died at 2 hours and 1 animal died at 4 hours after the dosing. As mortality was observed at 300mg/kg dose group, additional three female animals were treated with lower dose of 50mg/kg of test chemical (Step - I).

Administration of the test item at 50 mg/kg resulted did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed was observed at 24 hours after the dosing, three additional female animals were added to the study and treated with the dose of 50mg/kg of the test item (Step-II). Administration of the test item at 50 mg/kg resulted did not result in any signs of toxicity and mortality at 24 hours after the dosing. All animals from 50 mg/kg survived through the study period of 14 days. Gross pathological examination test item colored stomach mucosa and intestine with test item colored ingesta in all animals from 300 mg/kg dose group. Gross pathological examination did not reveal any abnormalities in all animals from 50mg/kg dose group.Under the condition of this, the lethal concentration (LD50) value for acute oral toxicity test was considered in between 50-300 mg/kg bw, when female Sprague Dawley rats were treated with the given test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

These results are supported by the another OECD 423 Guideline study designed and conducted to determine the acute oral toxicity profile of the test chemical in Sprague Dawley rats.

Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in diarrhoea, reduced locomotor activity, ataxic gait and convulsions with onset at 30 minutes to 2 hours after the dosing. One animal died at 4 hours after the dosing. As mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg resulted in diarrhoea, reduced locomotor activity, ataxic gait and convulsions with onset at 30 minutes after the dosing. Two animals died at 1 hour after the dosing. As mortality was observed at 300 mg/kg dose group, hence three female animals were treated with the lower dose of 50 mg/kg of the test item (Step - I).Administration of the test item at 50 mg/kg resulted in diarrhoea, piloerection and ataxic gait with onset at 4 to 6 hours after the dosing and no mortality after the dosing. As no mortality was observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 50 mg/kg of the test item (Step - II). Administration of the test item at 50 mg/kg resulted in diarrhoea and ataxic gait with onset at 4 to 6 hours after the dosing and no mortality after the dosing. All animals from 50 mg/kg dose group survived and exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities in animals sacrificed terminally from 50 mg/kg and 300 mg/kg dose groups. Gross pathological examination revealed stomach, small and large intestine distended with yellowish liquid ingesta in found dead animals from 300 mg/kg dose group.

Hence, The lethal concentration (LD50-Cut-off value) value for acute oral toxicity test was considered to be 300 mg/kg bw, when female Sprague Dawley rats were treated with test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Based on the available studies and applying the weight of evidence approach , the acute oral LD50 value of the test chemical can be considered to lie between 50- 300 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity.

Acute Toxicity: Inhalation

The study need not be conducted because the exposure of the test chemical via inhalation is not likely owing its vapour pressure and/or the possibility of exposure to aerosols, particles or droplets of inhalable size. The estimated vapour pressure of the test chemical was 5.47E-14 mm Hg. Hence, this endpoint was considered for waiver.

Acute toxicity: Dermal

Various studies have been reviewed to determine the exact single dose of the test chemical which is required to kill 50% of the test animals when dosed dermally. These include in vivo experimental studies performed on rats for the test chemicals.

A study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) in Sprague Dawley rats.In the dose range finding study a single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered with the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight. Administration of 2000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours.As the dose range finding study revealed no mortality or clinical signs at the maximum dose of 2000 mg/kg, the main study was initiated with two additional animals. The animals were administered with a dose of 2000 mg/kg body weight in sequential manner at 48 hours intervals.

Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

This is supported by the results of another OECD 402 Guideline study designed and conducted to evaluate the acute dermal toxicity profile of the test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. Hence, The LD50 value was considered to be >2000 mg/kg bw, when male and female Sprague Dawley rats were semi-occlusively treated with test chemical  by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity). 

Based on the available studies and applying the weight of evidence approach , the acute dermal LD50 value of the test chemical can be considered to be greater than 2000 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Not Classified” for acute dermal toxicity.

Justification for classification or non-classification

Based on the available results, the test chemical is likely to classify as acute oral toxicant in the "Category 3" as per CLP Regulation, and is not likely to classify for dermal and inhalation route of exposure.