Registration Dossier

Administrative data

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 test chemical. The LD50 value is 510 mg/kg bw. The study concluded that LD50 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 0.00072 Pa. 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 different studies conducted on rats 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:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Data is from Danish QSAR.
Qualifier:
according to
Guideline:
other: Predicted data
Principles of method if other than guideline:
Data is predicted using the Danish (Q)SAR Database
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
510 mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
510 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Mortality:
not specified
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Reliability Index

0.65 (0.5-0.75 = moderate prediction quality)

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 value was estimated to be 510 mg/kg bw, when rats were treated with the given test chemical orally.
Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity dose was estimated for the given test chemical.

The LD50 was estimated to be 510 mg/kg bw with Reliability Index 0.65 (0.5-0.75 = moderate prediction quality), when rats were treated with the test chemical orally.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
510 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from prediction report.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
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:
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:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 3 acute dermal toxicity studies as- WoE 2, WoE-3 and WoE 4.
Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
other: 1. Wistar 2. Wistar 3. not specified
Sex:
male/female
Details on test animals and environmental conditions:
1. TEST ANIMALS
- Source: Institute for Industrial Research and Toxicology
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 200±20g
- Fasting period before study: Animals were fasted overnight prior to test and food was offered three hours after dosing.
- Housing: Groups of three animals of same sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.
- Diet (e.g. ad libitum): Pelleted feed (ad libitum)
- Water (e.g. ad libitum): Fresh and clean water filtered through ‘Aqua Guard on line water filter’, was kept in glass bottles Ad libitum
- Acclimation period: The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25 degC
- Humidity (%): 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours dark.
2. TEST ANIMALS
- Source: In-House Bred
- Weight at study initiation: Male: Minimum: 248 g and Maximum: 271 g
(Prior to Treatment) Female: Minimum: 202 g and Maximum: 249 g
Bedding : All cages were provided with corn cobs
Husbandry : The animals were housed individually in polycarbonate cages
Room Sanitation : The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
Cages and water bottle : All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum): animals were provided conventional laboratory rodent diet ad libitum
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles
- Acclimation period: All animals were acclimatized to the test conditions for 6 days prior to administration of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.80 °C Maximum: 23.20 °C
- Humidity (%): Minimum: 50.60% Maximum: 63.20%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
3. not specified
Type of coverage:
other: 1. occlusive 2. occlusive 3. Dermal
Vehicle:
other: 1. unchanged (no vehicle) 2. water 3. not specified
Details on dermal exposure:
1. TEST SITE
- Area of exposure: Back skin of total body surface area.
- % coverage: Approximate 10 percent back skin of total body surface area.
- Type of wrap if used: Adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site of application was cleaned with lukewarm water

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight.
2. TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: Approx. 10% of body surface area of rat
- Type of wrap if used: porous gauze dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using distilled water
- Time after start of exposure: 24-hour exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): Individual rat was applied with an amount of test item moistened with 0.2 ml distilled water
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2ml
3. not specified
Duration of exposure:
1. not specified
2. 24 hrs
3. not specified
Doses:
1. Two groups:
Group-I: 2000 mg/kg b.wt (limit test)
Group-II: 2000 mg/kg b.wt (confirmatory test)
2. 2000 mg/kg body weight
3. 4000 mg/kg
No. of animals per sex per dose:
1. 10 (5male & 5 female)
2. Five male and five female wistar rats
3. not specified
Control animals:
not specified
Details on study design:
1. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Body weight:
The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).

Clinical signs
The treated animals were closely observed for clinical signs of intoxication, first 4 hours and thereafter for every 1 hrs interval for 24 hrs after dosing and twice a day for 14 days. All the rats were observed at least twice daily with the purpose of recording any symptoms of ill-health or behavioral changes. These observations included changes in skin and fur in the eyes and mucous membranes, respiratory, circulatory, central nervous and autonomic systems, somatomotor activity and behavioral changes. The following clinical signs were observed in female rats to characterize with erythema, hypersensitivity, edema etc. The clinical sign will be graded as 0 = Normal, + = Mild, ++= Moderate, +++ =High & ++++ = Severe.

Mortality
All the animals were observed for mortality at 30 minutes time interval for first six hours on the day of test compound administration and thereafter twice a day for 14 days.
2. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology were observed
3. not specified
Statistics:
1. not specified
2. not specified
3. not specified
Preliminary study:
1. not specified
2. not specified
3. not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
1. The test compound did not produce any mortality throughout the observation period of 14 days.
2. No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period
3. No mortality was observed at 4000 mg/kg bw in treated animals.
Clinical signs:
1. The test compound did not elicit any clinical signs at the dose level of 2000 mg/kg b.wt. in entire observation period.
2. All the animals were observed with normal clinical signs throughout the experimental period
3. not specified
Body weight:
1. All the animals treated with the test compound at the dose level of 2000 mg/kg b.wt showed normal gain in body weight as compared to control group on day 0th (pre treatment).
2. Mean body weight of male and female was observed with increase on day 7 and 14, as compared to day 0
3. not specified
Gross pathology:
1. NECROPSY FINDING
EXTERNAL
i.Skin- Skin and hair coat was observed wet.
ii.All external orifices- Normal
B. INTERNAL
i. Subcutaneous- No changes was observed.
ii. Superficial and deep lymph nodes- No change in mesenteric lymph node.

1.ABDOMINAL CAVITY
i.Opening and general examination- In the abdominal cavity all the organs were present in normal position.
ii.Spleen- No changes were recorded.
iii.Digestive system- No gross changes were observed in stomach and intestine.
iv.Liver and biliary ducts- No gross pathological changes were observed
v.Excretory system- No gross pathological changes were observed.
vi.Adrenal- Observed normal.
vii.Male/female genital organs – Showed normal colour, consistency and no inflammatory changes.

2. THORACIC CAVITY
i.Opening and general examination- Thoracic cavity was found to be normal without any fluid, mucous or blood etc.
ii.Lungs- No changes were recorded.
iii.Heart- No changes were observed in color and consistency. Heart found normal.
iv.Thyroid- Normal in shape, size and surface.

3. CRANIAL CAVITY
I.Brain- Normal in shape and size.
2. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality
3. not specified
Other findings:
1. not specified
2. not specified
3. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the given test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

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 for test chemical. The studies are summarized as below -

 

The acute dermal toxicity study of the given test chemical was conducted on Wistar albino rats under OECD guideline-402 Guideline for Testing of Chemicals.

LIMIT TEST (2000 mg/kg b.wt): Ten healthy wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test chemical was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7thand 14th(post treatment). The necropsy was performed on all animals at the termination of the study.

The test compound applied at the dose level of 2000 mg/kg b.wt in Wistar albino rats did not show any clinical signs of toxicity throughout the observation period of 14 days.  Furthermore, no mortality was observed throughout the period of observation (14 days). The necropsy was performed on all animals at the termination of the study did not show any gross pathological changes.

CONFIRMATORY TEST: After 72 hrs, a confirmatory test was conducted in same species of animals to confirm the limit test of test compound (OECD-402 guidelines). Ten healthy Wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test chemical was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at the termination of the study.

The test compound did not produce any mortality at the tested dose level of 2000 mg/kg b.wt in wistar albino rats throughout the period of observation. Furthermore, the test compound did not elicit any clinical signs of toxicity during the entire the observation period.

The body weight of each animal treated with test compound observed on day 0th (pre treatment) and then 7th and 14th (post treatment) showed normal gain as compared to day 0. Necropsy was conducted on day 15th(end of study) did not reveal any significant gross pathological changes related to compound toxicity.

Based on the results obtained from present investigation, it can be concluded that the test compound is non toxic to Wistar albino rats at the dose level of 2000 mg/kg body weight. The acute dermal LD50 of test compound was considered to be >2000 mg/kg b.wt. Thus, according to CLP criteria the test compound can be classify under non toxic category at the tested dose level of 2000 mg/kg body weight.

 

The above study is supported with another study mentioned in report for the test chemical in rats and performed as per OECD No. 402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.

On test day 0, an amount of test item moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. All the animals were observed for mortality, clinical signs, body weight and gross pathology. No mortality was observed in any animal, normal clinical signs were observed. Mean body weight of male and female was observed with increase on day 7 and 14, as compared to day 0. No pathological abnormality was observed. Thus the LD50 value was considered to be >2000 mg/kg bw, when male and female wistar rats were treated with test chemical by dermal application.

 

Both the above studies are further supported with the study mentioned in authoritative database for the test chemical in rats at the concentration of 4000 mg/kg bw. Animals were observed for mortality. No mortality was observed at 4000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be >4000 mg/kg bw, when rats was treated with the given test chemical by dermal application.

Thus, based on the above summarised studies on test chemical, it can be 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from report.

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 and mice for test chemical. The studies are summarized as below -

 

Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity dose was estimated for the given test chemical. The LD50 was estimated to be 510 mg/kg bw with Reliability Index 0.65 (0.5-0.75 = moderate prediction quality), when rats were treated with the test chemical orally.

 

The above prediction is supported with the another QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity dose was estimated for the given test chemical. The LD50 was estimated to be 870 mg/kg bw with Reliability Index 0.7 (0.5-0.75 = moderate prediction quality), when mice were treated with the test chemical orally.

 

These predictions are supported by the study mentioned in authoritative database for the given test chemical. The study was conducted in rats at the concentration of 1000 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 1000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be 1000 mg/kg bw, when rats was treated with the given test chemical via oral route.

 

All the above studies are further supported with the study mentioned in study report for the given test chemical. The reported study was designed and conducted to determine the acute oral toxicity profile of the given test chemical as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) 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 loss of righting reflex, reduced locomotor activity and ataxic gait with onset at 10 minutes to 1 hour after the dosing and no mortality at 24 hours after the dosing. As no 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 loss of righting reflex, reduced locomotor activity and ataxic gait with onset at 10 minutes to 1 hour after the dosing and no mortality after the dosing.

No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea, exophthalmoses, and distension, loss of righting reflex, markedly reduced locomotor activity, reduced locomotor activity and ataxic gait with onset at 10 minutes to 6 hours after the dosing. Three animals died on day 1 after the dosing.

All animals from 300 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 300 mg/kg dose group. Gross pathological examination revealed unabsorbed residual test item in stomach in found dead animals from 2000 mg/kg dose group. 

Under the condition of the study, the acute oral LD50 value of the given test chemical was considered in between 300 - 2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category 4 (300 – ≤ 2000)” criteria of CLP.

 

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 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 0.00072 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

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 for test chemical. The studies are summarized as below -

 

The acute dermal toxicity study of the given test chemical was conducted on Wistar albino rats under OECD guideline-402 Guideline for Testing of Chemicals.

LIMIT TEST (2000 mg/kg b.wt): Ten healthy wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test chemical was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7thand 14th(post treatment). The necropsy was performed on all animals at the termination of the study.

The test compound applied at the dose level of 2000 mg/kg b.wt in Wistar albino rats did not show any clinical signs of toxicity throughout the observation period of 14 days.  Furthermore, no mortality was observed throughout the period of observation (14 days). The necropsy was performed on all animals at the termination of the study did not show any gross pathological changes.

CONFIRMATORY TEST: After 72 hrs, a confirmatory test was conducted in same species of animals to confirm the limit test of test compound (OECD-402 guidelines). Ten healthy Wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test chemical was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at the termination of the study.

The test compound did not produce any mortality at the tested dose level of 2000 mg/kg b.wt in wistar albino rats throughout the period of observation. Furthermore, the test compound did not elicit any clinical signs of toxicity during the entire the observation period.

The body weight of each animal treated with test compound observed on day 0th (pre treatment) and then 7th and 14th (post treatment) showed normal gain as compared to day 0. Necropsy was conducted on day 15th(end of study) did not reveal any significant gross pathological changes related to compound toxicity.

Based on the results obtained from present investigation, it can be concluded that the test compound is non toxic to Wistar albino rats at the dose level of 2000 mg/kg body weight. The acute dermal LD50 of test compound was considered to be >2000 mg/kg b.wt. Thus, according to CLP criteria the test compound can be classify under non toxic category at the tested dose level of 2000 mg/kg body weight.

 

The above study is supported with another study mentioned in report for the test chemical in rats and performed as per OECD No. 402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.

On test day 0, an amount of test item moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. All the animals were observed for mortality, clinical signs, body weight and gross pathology. No mortality was observed in any animal, normal clinical signs were observed. Mean body weight of male and female was observed with increase on day 7 and 14, as compared to day 0. No pathological abnormality was observed. Thus the LD50 value was considered to be >2000 mg/kg bw, when male and female wistar rats were treated with test chemical by dermal application.

 

Both the above studies are further supported with the study mentioned in authoritative database for the test chemical in rats at the concentration of 4000 mg/kg bw. Animals were observed for mortality. No mortality was observed at 4000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be >4000 mg/kg bw, when rats was treated with the given test chemical by dermal application.

Thus, based on the above summarised studies on test chemical, it can be 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 on 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 value and range 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.