Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified 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 3.28E-013 Pa (2.46E-015 mm Hg). 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 and rabbits for the test chemical. The 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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Data from experimental study report.
Qualifier:
equivalent or similar to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity of the given test chemical was performed in female rats
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes
Species:
rat
Strain:
other: SPF Wistar,Hoe: WISKF (SPF 71)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 234-244g (average weight 238g)
- Fasting period before study: The rats were not given any food for 16 hours before administered, 2 hours after the dye was administered,
- Housing: the animals were kept in plastic cages on plane rakes
- Diet (e.g. ad libitum): The animals were fed as the Postural diet ALTROMIN 1324 of the company Altromin GmbH in Lage / Lippe, ad libitum
- Water (e.g. ad libitum): tap water. libitum


Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5000mg/kg bw

- Justification for choice of vehicle: Test material suspended in 25% sesame oil

DOSAGE PREPARATION (if unusual): Test material suspended in 25% sesame oil
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 female rat
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination were performed
Statistics:
not specified
Preliminary study:
not specified
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No animal died on administration of 5000 mg/kg body weight.
Clinical signs:
The animals showed normal behavior
Body weight:
The body weight gain at the follow-up was regular.
Gross pathology:
not specified
Other findings:
After administration of the dye, a dark blue feces and blue urine staining were observed.
Interpretation of results:
other: Not classified
Conclusions:
The LD50 value was considered to be >5000 mg/kg bw, when female rats were treated with the given test chemical orally via gavage.
Executive summary:

In an acute oral toxicity study, 10 female SPF Wistar rats strain Hoe: WISKF (SPF 71) weighing 234-244g (average weight 238g) rats were treated with the given test chemical at the dose concentration of 5000 mg/kg bw.

The 25% suspension of test material was dissolved in sesame oil and was administered once via oral gavage route.

The rats were not given any food for 16 hours before application. 2 hours after the dye was administered, the animals were fed again. The observation time after administration was 14 days. During this time, the animals were kept Weekly weighed, the animals received as feed the ALTROMIN stabilizer 1324 of the company Altromin GmbH in Lage/Lippe and tap water. Food and water were offered ad libitum.

Animals were observed for mortality and clinical signs changes for 14 days. The experimental animals were killed at the end of the follow-up period in anesthesia, dissected and examined macroscopically.

No animal died on administration of 5000 mg/kg body weight. After the application, the animals showed normal behavior. The body weight gain at the follow-up was regular. After administration of the dye, a dark blue feces and blue urine staining were observed.

Under the condition of the study, the LD50 value was considered to be >5000 mg/kg bw, when female rats were treated with the given test chemical orally via gavage.  

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 1 and from experimental study 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:
other: 1. rat 2. rabbit 3. rat
Strain:
other: 1. Sprague-Dawley 2. not specified 3. Wistar
Sex:
male/female
Details on test animals and environmental conditions:
1. TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Age at study initiation: Young adult male and female rats aged between 6 – 9 weeks were used.
- Weight at study initiation: The weight range of approximately 233.1 to 271.0 grams at initiation of dosing were used.
Body weights at the start : Male Mean : 268.48 g (= 100 %); Minimum : 264.2 g (- 1.59 %); Maximum : 271.0 g (+ 0.94 %)
Female Mean: 241.38 g (= 100 %); Minimum : 233.1 g (- 3.43 %); Maximum : 248.3 g (+ 2.87 %)
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period : 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was maintained at 20.1 to 22.3 degree centigrade.
- Humidity (%): Room humidity was maintained at 55.7% to 59.6%.
- Air changes (per hr): The animal room was independently provided with at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
2. not specified
3. TEST ANIMALS
- Source: Institute for Industrial Research and Toxicology.
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 200±20 g
- Identification : By cage tag and corresponding colour body marking.
- Housing: Groups of two 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 supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi, India.
- 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: One week
- Randomization : After acclimatization and veterinary examination all the animals randomly divided into two groups and each group having five male and five female rats.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 degC
- Humidity (%): 40-60 %
- Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): Illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Type of coverage:
other: 1. occlusive 2. Dermal 3. occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
1. TEST SITE
- Area of exposure: Dorsal surface and sides from scapular to pelvic area.
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: Porous gauze dressing and non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
2. not specified
3. TEST SITE
- Area of exposure: Back skin of total body surface area.
- % coverage: Approximate 10% area.
- Type of wrap if used: Adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cleaned with lukewarm water wiping the test compound.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg b.wt
Duration of exposure:
1. 24 hours
2. not specified
3. 24 hours
Doses:
1. A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).
2. 2000 mg/kg bw
3. Group - I : 2000 mg/kg b.wt
Group - II : 2000 mg/kg b.wt
No. of animals per sex per dose:
1. 10 (5/sex).
2. not specified
3. Group - I : 2000 mg/kg b.wt : 5 female and 5 male
Group - II : 2000 mg/kg b.wt : 5 female and 5 male
Control animals:
not specified
Details on study design:
1. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.

Evaluation of Dermal Reaction:
Dermal reaction was observed daily for study period of 14 days.

Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.

Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
2. not specified
3. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes, necropsy was carried out on all animals that died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes.
- 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 hours 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 autonomous systems, somatomotor activity and behavior changes. The following clinical signs were observed in rats to characterize with erythema, hypersensitivity, edema etc.
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.
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 was observed
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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
Mortality:
1. Mortality was not observed during the study period of 14 days.
2. No mortality was observed at 2000 mg/kg bw.
3. The test compound did not produce any mortality throughout the observation period of 14 days.
Clinical signs:
1. Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days.
2. not specified
3. The test compound did not elicit any clinical signs at the dose level of 2000 mg/kg b.wt. in entire observation period.
Body weight:
1. Sex : Male Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 8.63% and 17.60% respectively.
Sex : Female Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.20% and 9.02% respectively.
2. not specified
3. 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).
Gross pathology:
1. Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
2. not specified
3. Necropsy finding:
A.EXTRENAL:
i:skin: skin and hair coat was observed wet
ii:all external orifices: normal

B.INTERNAL:
i:subcutaneous: no chnage was observed
ii:superficial and deep lymph node: no chnage in mesenteric lymph node

ABDOMINAL CAVITY:
i. opening and general examination: in the abdominal cavity all the organs were present in normal position
ii. spleen:no changes were observed
iii. digestive sysytem: no gross changes were observed in stomach and intestine
iv. liver and biliary ducts: no gross pathological changes were observed
v. excretory sysytem: no gross pathological changes were observed
vi. adrenal: observed normal
vii. male/female genital organs: showed normal color,consistancy and no inflammartory 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 observed
iii. heart: no changes were observed in color and consistancy. heart found normal
iv. thyroid: normal in shape,size and surface

3. CRANIAL CAVITY:
brain: normal in shape and size
Other findings:
1. - Other observations: Evaluation of Dermal Reaction
Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
2. not specified
3. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the 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 and rabbits for test chemical. The studies are summarized as below -

 

The reported study was mentioned in study report to determine the acute dermal toxicity profile of the given test chemical in Sprague Dawley rats according to OECD Guideline 402 (Acute Dermal Toxicity).

The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Animals were observed for clinical signs, mortality, until sacrifice.Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern. Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14. Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).

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, LD50 was considered to be >2000mg/kg bw,when male and female Sprague Dawley rats was treated with test chemical by dermal application.

The above study is supported with another study mentioned in database for the test chemical. The acute dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 2000 mg/kg bw. Animals were observed for mortality. No mortality was observed in treated rabbits at2000 mg/kg bw. Therefore, LD50 value was considered to be >2000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application to the skin.

 

All the above studies are further supported with the study mentioned in report for the test chemical. 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.

In 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 (pretreatment), 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.

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 (pretreatment), 7thand 14th(post treatment). The necropsy was performed on all animals at the termination of the study. The test compound did not produce any mortality throughout the observation period of 14 days.

Furthermore, the test compound did not elicit any clinical signs at the dose level of 2000 mg/kg b.wt. in entire observation period. 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). Necropsy was conducted on day 15th (end of study) did not reveal any significant gross pathological changes related to compound toxicity.

The results obtained from present investigation can be concluded that the LD50 value was considered to be >2000 mg/kg bw, when Wistar albino rats were occlusively treated with the given test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity). Thus, according to CLP criteria for acute toxicity rating for the chemicals, the test chemical can be classify under non toxic category at the tested dose level of 2000 mg/kg body weight.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. 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
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from report.

Additional information

Acute oral toxicity:

In an acute oral toxicity study, 10 female SPF Wistar rats strain Hoe: WISKF (SPF 71) weighing 234-244g (average weight 238g) rats were treated with the given test chemical at the dose concentration of 5000 mg/kg bw.

The 25% suspension of test material was dissolved in sesame oil and was administered once via oral gavage route. The rats were not given any food for 16 hours before application. 2 hours after the dye was administered, the animals were fed again. The observation time after administration was 14 days. During this time, the animals were kept Weekly weighed, the animals received as feed the ALTROMIN stabilizer 1324 of the company Altromin GmbH in Lage/Lippe and tap water. Food and water were offered ad libitum.

Animals were observed for mortality and clinical signs changes for 14 days. The experimental animals were killed at the end of the follow-up period in anaesthesia, dissected and examined macroscopically.

No animal died on administration of 5000 mg/kg body weight. After the application, the animals showed normal behaviour. The body weight gain at the follow-up was regular. After administration of the dye, a dark blue faeces and blue urine staining were observed.

Under the condition of the study, the LD50 value was considered to be >5000 mg/kg bw, when female rats were treated with the given test chemical orally via gavage.  

 

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 3.28E-013 Pa (2.46E-015 mm Hg). 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 and rabbits for test chemical. The studies are summarized as below -

 

The reported study was mentioned in study report to determine the acute dermal toxicity profile of the given test chemical in Sprague Dawley rats according to OECD Guideline 402 (Acute Dermal Toxicity).

The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Animals were observed for clinical signs, mortality, until sacrifice.Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern. Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14. Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).

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, LD50 was considered to be >2000mg/kg bw,when male and female Sprague Dawley rats was treated with test chemical by dermal application.

The above study is supported with another study mentioned in database for the test chemical. The acute dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 2000 mg/kg bw. Animals were observed for mortality. No mortality was observed in treated rabbits at2000 mg/kg bw. Therefore, LD50 value was considered to be >2000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application to the skin.

 

All the above studies are further supported with the study mentioned in report for the test chemical. 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.

In 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 (pretreatment), 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.

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 (pretreatment), 7thand 14th(post treatment). The necropsy was performed on all animals at the termination of the study. The test compound did not produce any mortality throughout the observation period of 14 days.

Furthermore, the test compound did not elicit any clinical signs at the dose level of 2000 mg/kg b.wt. in entire observation period. 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). Necropsy was conducted on day 15th (end of study) did not reveal any significant gross pathological changes related to compound toxicity.

The results obtained from present investigation can be concluded that the LD50 value was considered to be >2000 mg/kg bw, when Wistar albino rats were occlusively treated with the given test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity). Thus, according to CLP criteria for acute toxicity rating for the chemicals, the test chemical can be classify under non toxic category at the tested dose level of 2000 mg/kg body weight.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. 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 the LD50 value is >2000 mg/kg bw, for acute oral and acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.