Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on study conducted for the test chemical. 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 0.000750 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 study conducted on rats for the test chemical. The studies concluded that 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:
guideline study
Justification for type of information:
Experimental test result performed using standard test guidelines
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
To assess the toxicity potential of test chemical after single oral administration in rats and an observation period of 14 days.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Supplier / Source: In-house animals, bred at Animal House, sa-FORD. CPCSEA Registration No. 1256/bc/09/CPCSEA.
Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
Body weight of animals :Minimum: 132 g Maximum: 158 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
Age: 8- 10 weeks at the time of dosing.
Acclimatisation:Animal nos. 1-3 were acclimatized for 5 days and 4-6 for 10 days, prior to administration of the test item.
Identification :The animals were marked temporarily on tail, permanently on toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number experimental start and completion date.

Husbandry Conditions
Diet :All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 400004.
Bedding :All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) SPAR – 25 /2014.
Water : Aqua guard filtered tap water was provided ad libitum via drinking bottles.
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.

Experimental Room Condition
Temperature :Minimum: 19.80 °C Maximum: 23.20 °C
Relative humidity :Minimum: 48.70% Maximum: 69.20%
Light-dark-rhythm : 12:12
Air Changes : More than 12 changes per hour
Route of administration:
oral: feed
Vehicle:
corn oil
Details on oral exposure:
The maximum dose volume administered was 10 ml/kg body weight.
Six female Wistar rats fasted for 16-18 hrs; were selected for acute oral toxicity study. The feed was withheld prior to dosing and 4 hours post dosing but drinking water was provided ad libitum. The time interval between dosing was determined by the onset, duration and severity of toxic signs. Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and one mortality was observed on day 1 post dosing. Hence, further dosing was stopped. The duration of dosing was between 11:09 to 11:29 a.m.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Six femal rates
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After test item administration, individual animals were frequently observed at 30 minutes, 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 Observation
After test item administration, individual animals were frequently observed at 30 minutes, 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.
Mortality
All animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Body weight
All rats were weighed on days 0 (prior to dosing), 7 and 14.
Pathology
At the end of 14 day observation period, all rats were euthanised by overdose of CO2 for external and internal observations.
Statistics:
Not specified
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No mortality was observed in the animals treated with 2000 mg/kg dose throught out the 14 days observation period, except animal no. 5 was found dead on day 1 post dosing (refer table 4).
Clinical signs:
At 2000 mg/kg, animal no. 1 was observed with normal signs at 30 minutes and 1 hour, mild lethargy at 2, 3 and 4 hours, mild diarrhea at 2, 3, 4 hours and on day 1 and normal thereafter till the end. Animal no. 2 was observed with normal signs at 30 minutes and 1 hour, mild lethargy and diarrhea at 2, 3 and 4 hours and normal from day 1 till the end. Animal no. 3 was observed with normal signs at 30 minutes and 1 hour, mild lethargy at 2, 3 and 4 hours, mild diarrhea at 3, 4 hours and on day 1 and normal from day 2 till the end. Animal no. 4 was observed with normal signs at 30 minutes and 1 hour, mild lethargy at 2, 3, 4 hours, on day 1 and 2, mild diarrhea at 2, 3 and 4 hours and normal from day 3 till the end. Animal no. 5 was observed with normal signs at 30 minutes and 1 hour, mild lethargy at 2, 3, 4 hours and on day 1, mild diarrhea, abdominal breathing and found dead on day 1. Animal no. 6 was observed with normal signs at 30 minutes and 1 hour, mild lethargy at 2, 3, 4 hours, on day 1 and 2, mild diarrhea at 3 and 4 hours and normal from day 3 till the end (refer table 3).
Body weight:
Mean Body weight of all surviving animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0 (refer table 1 and 2).
Gross pathology:
Found dead animal no. 5 was observed with soiled anal region with feces during external examination, whereas mild red discoloration of lungs and moderately enlarged adrenals during internal examination. No external and internal gross pathological changes were seen in the other animals treated with 2000 mg/kg body weight during terminal sacrifice (refer table 5).

Table 1: Individual Animal Body Weight (g) and Body Weight Changes(%)

 

Sex:Female

Animal No.

Group/ Dose (mg/kg)

Body Weight (gram)

Body Weight Change (%)

Day 0

Day 7

Day 14

Found Dead

Day

0-7

Day

0-14

1

G1/ 2000

138

165

180

-

19.57

30.43

2

144

183

189

-

27.08

31.25

3

132

157

156

-

18.94

18.18

4

158

174

186

-

10.13

17.72

5

137

-

-

122

-

-

6

139

162

175

-

16.55

25.90

Key:- = Not applicable

Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)

 

Sex:Female

Group/ Dose (mg/kg)

Rats Body Weight (g)

Body Weight Changes (%)

Day 0

Day 7

Day 14

0-7

0-14

G1/ 2000

Mean

141.33

168.20

177.20

18.45

24.70

SD

9.03

10.33

13.03

6.10

6.49

n

6

5

5

5

5

Keys:SD = Standard Deviation, n = Number of Animals

Table 3: Individual Animal Clinical Signs and Symptoms

 

Sex:Female

Animal No.

Group/ Dose (mg/kg)

Hours (Day 0)

1/2

1

2

3

4

1

G1/ 2000

1

1

49+

99+

49+

99+

49+

99+

2

1

1

49+

99+

49+

99+

49+

99+

3

1

1

99+

49+

99+

49+

99+

4

1

1

49+

99+

49+

99+

49+

99+

5

1

1

99+

99+

99+

6

1

1

99+

49+

99+

49+

99+

 

Animal No.

Group/ Dose (mg/kg)

Days post dosing

1

2

3

4

5

6

7

8

9

10

11

12

13

14

1

G1/ 2000

49+

1

1

1

1

1

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

1

1

1

1

1

3

49+

1

1

1

1

1

1

1

1

1

1

1

1

1

4

99+

99+

1

1

1

1

1

1

1

1

1

1

1

1

5

49+

99+

4+

2

-

-

-

-

-

-

-

-

-

-

-

-

-

6

99+

99+

1

1

1

1

1

1

1

1

1

1

1

1

Keys:  - = Not applicable, 1 = Normal, 2 = Found dead, 4 = Abdominal breathing, 49 = Diarrhoea,                    99 = Lethargy,+= Mild.

Table 4: Individual Animal Mortality Record

 

Sex:Female

Animal No.

Group/ Dose (mg/kg)

Day of Observation (Day 0 to 14)

Morning Observations

Evening Observations

1

G1/ 2000

No mortality and morbidity

No mortality and morbidity

2

No mortality and morbidity

No mortality and morbidity

3

No mortality and morbidity

No mortality and morbidity

4

No mortality and morbidity

No mortality and morbidity

5

No mortality and morbidity till day 1 Found dead on day 1

No mortality and morbidity on day 0

 

6

No mortality and morbidity

No mortality and morbidity

Table 5: Gross Necropsy Observation

Sex:Female                                                                                                                                        

Animal No.

Group/ Dose (mg/kg)

Mode of Death

Gross Observation

External

Internal

1

G1/ 2000

Terminal sacrifice

No abnormality detected

No abnormality detected

2

Terminal sacrifice

No abnormality detected

No abnormality detected

3

Terminal sacrifice

No abnormality detected

No abnormality detected

4

Terminal sacrifice

No abnormality detected

No abnormality detected

5

Found

dead

No abnormality detected

Lungs: Red discoloration (mild)

Adrenal glands: Enlarged (moderate)

6

Terminal sacrifice

No abnormality detected

No abnormality detected

 



Interpretation of results:
other: Not classified
Conclusions:
Acute Oral Toxicity of test chemical was studied in Rats, This study was performed as per OECD No. 423.
Under the condition of the study,Acute oral LD50 of test chemical was determined to be >2000 mg/kg body weight
Executive summary:

Acute Oral Toxicity of test chemical was studied in Rats, This study was performed as per OECD No. 423.

Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.

Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and one mortality was observed on day 1 post dosing. Hence, further dosing was stopped.

Body weights of surviving animals were recorded on day 0 (prior to dosing) 7 and 14. The animal was weighed immediately after found dead. Mean Body weight of all surviving animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0

Under the conditions of this; the LD50 value of test chemical in female rats was >2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 1 and from 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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental result performed using standard test methods
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
To assess the dermal toxicity of test chemical after dose application by dermal route in rats and an observation period of 14 days.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animals and Husbandry
Test System Specifications
Species :Rat (Rattus norvegicus)
Strain :Wistar
Sex :Male and Female
Number of Animals :10 (Five per sex)
Supplier/Source :In-House Bred at Sa-Ford, Animal Facility
(CPCSEA Registration No. 1256/bc/09/CPCSEA)
Health Status : Healthy young adult animals were used for the study. Females were nulliparous and non pregnant
Body weight of animals :Male: Minimum: 228 g and Maximum: 255 g
(Prior to Treatment) Female: Minimum: 213 g and Maximum: 238 g
Acclimatisation :All animals were acclimatized to the test conditions for 5 days prior to administration of the test item.
Identification : During Acclimatization, animals were temporarily marked by permanent marker, on their tails. After acclimatization, the animals were marked by toe pad micro tattooing and cage cards. Individual cage cards were labeled with study no., study type, test system, sex, dose, group, animal number, experimental start and completion date.
Randomization: Animals were selected manually. No computer generated randomization program was used.

Husbandry Conditions
Diet : All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004.
Bedding : All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 25/2014
Water : Aqua guard filtered tap water was provided ad libitum via drinking bottles.
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.

Experimental Room Condition
Temperature : Minimum: 19.80 °C Maximum: 23.20 °C
Relative humidity: Minimum: 50.60% Maximum: 61.10%
Light-dark-rhythm: 12:12
Air Changes : More than 12 changes per hour
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
8.2 Preparation of Application Site
Approximately 24 h prior to treatment, the fur of dorsal area of the trunk (approximately 10% body surface area) of rats was clipped by using clipper.
8.3 Test Item Application Procedure
The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with an amount of test item, calculated based on the density (1.0898) and latest body weight. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item. At the end of the exposure period, residual test item was removed by using distilled water. The animals were dosed between 11:19 to 11:32 a.m.
8.4 Limit Test
Five male and five female wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight.
Since no test item related mortality was observed, the study was terminated with limit test only.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 per sex (male and female)
Control animals:
not required
Details on study design:
Preparation of Application Site
Approximately 24 h prior to treatment, the fur of dorsal area of the trunk (approximately 10% body surface area) of rats was clipped by using clipper.

Test Item Application Procedure
The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with an amount of test item, calculated based on the density (1.0898) and latest body weight. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item. At the end of the exposure period, residual test item was removed by using distilled water. The animals were dosed between 11:19 to 11:32 a.m.

Limit Test
Five male and five female wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight.
Since no test item related mortality was observed, the study was terminated with limit test only.


Clinical Observation
After test item administration, 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.

Mortality
Animals were observed twice daily for any mortality during the experimental period.

Body weight
All rats were weighed on days 0 (prior to dosing), 7 and 14.

Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs).

Statistical Analysis
No statistical analysis was performed since the study was terminated with limit test.

Pathology
At the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.
Preliminary study:
No details available
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no other details available
Mortality:
No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period (refer table 3).
Clinical signs:
All the animals were observed with normal clinical signs throughout the experimental period (refer table 2).
Body weight:
Mean body weight of both males and females were observed with increase on day 7 and 14, as compared to day 0. ( refer table 1 and 4).
Gross pathology:
The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality (refer table 5).

Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)

 

Dose:2000 mg/ kg bodyweight                                                                              Density:1.0898

Animal No.

Sex

Dose Volume*

(ml)

Body Weight (gram)

Body Weight Change (%)

Day 0

Day 7

Day 14

Day 0-7

Day 0-14

1

Male

0.46

251

262

276

4.38

9.96

2

0.47

254

257

236

1.18

-7.09

3

0.43

236

256

283

8.47

19.92

4

0.47

255

284

306

11.37

20.00

5

0.42

228

247

279

8.33

22.37

6

Female

0.39

213

208

210

-2.35

-1.41

7

0.42

231

236

237

2.16

2.60

8

0.41

224

224

233

0.00

4.02

9

0.44

238

237

245

-0.42

2.94

10

0.40

217

223

232

2.76

6.91

Key:* = based on density and day 0 body weight


Table 2: Individual Animal Clinical Signs and Symptoms

 

Dose:2000 mg/kg body weight

Animal

No.

Sex

Hour(s) - Day 0

Day

1

2

3

4

1

2

3

4

5

6

7

1

Male

1

1

1

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

1

1

3

1

1

1

1

1

1

1

1

1

1

1

4

1

1

1

1

1

1

1

1

1

1

1

5

1

1

1

1

1

1

1

1

1

1

1

6

Female

1

1

1

1

1

1

1

1

1

1

1

7

1

1

1

1

1

1

1

1

1

1

1

8

1

1

1

1

1

1

1

1

1

1

1

9

1

1

1

1

1

1

1

1

1

1

1

10

1

1

1

1

1

1

1

1

1

1

1

 

Animal

No.

Sex

Day

8

9

10

11

12

13

14

1

Male

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

3

1

1

1

1

1

1

1

4

1

1

1

1

1

1

1

5

1

1

1

1

1

1

1

6

Female

1

1

1

1

1

1

1

7

1

1

1

1

1

1

1

8

1

1

1

1

1

1

1

9

1

1

1

1

1

1

1

10

1

1

1

1

1

1

1

Keys: 1 = Normal

Table 3: Individual Animal Mortality Record

 

Dose:2000 mg/kg body weight

       Animal No.

Sex

Days of Observation (0 to 14)

Morning Observations

Evening Observations

1

Male

No mortality and morbidity

No mortality and morbidity

2

No mortality and morbidity

No mortality and morbidity

3

No mortality and morbidity

No mortality and morbidity

4

No mortality and morbidity

No mortality and morbidity

5

No mortality and morbidity

No mortality and morbidity

6

Female

No mortality and morbidity

No mortality and morbidity

7

No mortality and morbidity

No mortality and morbidity

8

No mortality and morbidity

No mortality and morbidity

9

No mortality and morbidity

No mortality and morbidity

10

No mortality and morbidity

No mortality and morbidity

Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)

 

Dose:2000 mg/kg body weight

Sex

Body Weight (gram)

Body Weight Changes (%)

Day 0

Day 7

Day 14

Day 0-7

Day 0-14

Male

Mean

244.80

261.20

276.00

6.75

13.03

SD

12.11

13.85

25.29

3.98

12.22

n

5

5

5

5

5

Female

Mean

224.60

225.60

231.40

0.43

3.01

SD

10.16

11.80

13.01

2.07

3.00

n

5

5

5

5

5

Keys:SD= Standard deviation, n = Number of animals



Table 5: GrossNecropsyObservation

 

 Dose:2000 mg/kg body weight                                               Mode of Death:Terminal Sacrifice

Animal No.

Sex

Gross Observation

External

Internal

1

Male

No abnormalities detected

No abnormalities detected

2

No abnormalities detected

No abnormalities detected

3

No abnormalities detected

No abnormalities detected

4

No abnormalities detected

No abnormalities detected

5

No abnormalities detected

No abnormalities detected

6

Female

No abnormalities detected

No abnormalities detected

7

No abnormalities detected

No abnormalities detected

8

No abnormalities detected

No abnormalities detected

9

No abnormalities detected

No abnormalities detected

10

No abnormalities detected

No abnormalities detected


Interpretation of results:
other: Not classified
Conclusions:
Under the conditions of study in acute dermal toxicity study,the acute dermal median lethal dose of test chemical was determined to be >2000 mg/kg bw when tested in rats.
Executive summary:

Acute Dermal Toxicity was studied for test chemical in Wistar Rats,This study was 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. Approximately 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 based on the density (1.0898) and latest body weight was applied by single dermal application and observed for 14 days after treatment.

On test day 0, calculated amount of test item 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.

Under the conditions of this; acute dermal toxicity study of test chemical in rats is as given below: The acute dermal median lethal dose of test chemical was  > 2000 mg/kg body weight. and the substance is not classified as per the CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 1 and from study report

Additional information

Acute oral toxicity:

Acute Oral Toxicity of test chemical was studied in Rats, This study was performed as per OECD No. 423.

Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.

Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and one mortality was observed on day 1 post dosing. Hence, further dosing was stopped.

Body weights of surviving animals were recorded on day 0 (prior to dosing) 7 and 14. The animal was weighed immediately after found dead. Mean Body weight of all surviving animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0

Under the conditions of this; the LD50 value of test chemical in female rats was >2000 mg/kg body weight.

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 0.000750 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.

Acute dermal toxicity:

Acute Dermal Toxicity was studied for test chemical in Wistar Rats,This study was 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. Approximately 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 based on the density (1.0898) and latest body weight was applied by single dermal application and observed for 14 days after treatment.

On test day 0, calculated amount of test item 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.

Under the conditions of this; acute dermal toxicity study of test chemical in rats is as given below: The acute dermal median lethal dose of test chemical was  > 2000 mg/kg body weight. and the substance is not classified as per the CLP regulation.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that 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.