Potassium iodide

Endpoint summary

Description of key information

Acute toxicity:Oral route

The acute oral LD50 (Cut-off)value of test chemical was considered in between 2500 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical is considered to be Not classified as per the CLP regulation.

Acute toxicity:Inahalation:

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 substance, High melting point, which is reported as 685°C; Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of range 225 micrometer to 500 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  

Acute toxicity:Dermal

Under the conditions of this; acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Principles of method if other than guideline:

The aim of this study was 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:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
Species:Rattus norvegicus (Rat)
Strain-Wistar Number
Sex:Six Females
Supplier / Source: In-house animals
Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
Body weight of animals:Minimum: 144 g Maximum: 167 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
Age:9-11 weeks at the time of dosing.
Acclimatisation:Animal nos. 1-3 were acclimatized for 7 days and 4-6 for 9 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.: 400010.
Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) SPAR – 26 /2014 and SPAR – 27 /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.

ENVIRONMENTAL CONDITIONS
Experimental Room ConditionTemperature:Minimum: 19.60 °C Maximum: 21.40 °C
Relative humidity:Minimum: 47.40% Maximum: 58.60%
Light-dark-rhythm: 12:12
Air Changes: More than 12 changes per hour

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage):10 ml/kg body weight
- Justification for choice of vehicle: Distilled water was seleted as a vehicle based on solubility testing.

Doses:

2000 mg/kg

No. of animals per sex per dose:

G1 - 2000 mg/kg bw-3 Female Rats
G2 - 2000 mg/kg bw-3 Female Rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- 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 surviving animals were observed once a day during the 14 day observation period.
Mortality - All surviving 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. Animals were weighed immediately after found dead.

Statistics:

Not specified

Preliminary study:

Not specified

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Non toxic

Mortality:

Mortality was observed in the animals no. 2 and 5 on day 0 and on day 1 respectively post dosing

Clinical signs:

other: At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours, Salivation was observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes and

Gross pathology:

During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen. During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion congestion was observed in animal no. 5. .

Table 1: Individual Animal Body Weight (g) andBody 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	163	186	207	-	14.11	26.99
2		167	-	-	161	-	-
3		157	179	199	-	14.01	26.75
4		144	165	178	-	14.58	23.61
5		147	-	-	143	-	-
6		152	172	190	-	13.16	25.00

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	155.00	175.50	193.50	13.97	25.59
	SD	9.01	9.04	12.45	0.59	1.59
	n	6	4	4	4	4

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	99^+	99^+ 145+	99^+ 145+
2		1	1	99^+	99^+ 145+	99^++ 145+,2
3		1	1	99^+	99^+ 145+	99^+ 145+
4		1	1	99^+	99^+	99^+ 145+
5		1	1	99^+	99^+	99^+ 145+
6		1	1	1	99^+	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		1		1		1		1		1		1		1		1		1		1		1		1		1		1
2			-		-		-		-		-		-		-		-		-		-		-		-		-		-
3			1		1		1		1		1		1		1		1		1		1		1		1		1		1
4			1		1		1		1		1		1		1		1		1		1		1		1		1		1
5			99^++, 2		-		-		-		-		-		-		-		-		-		-		-		-		-
6			1		1		1		1		1		1		1		1		1		1		1		1		1		1

Keys:  - = Not applicable, 1 = Normal, 2 = Found dead, 99 = Lethargy, 145 = Salivation,⁺= Mild, ++ = Moderate.

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 till day 0	Found dead on day 0 post dosing
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	No mortality and morbidity till day 0 Found dead on day 1 post dosing
6		No mortality and morbidity	No mortality and morbidity

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 (Cut-off)value of test chemical was considered to be 2500 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical is considered to be Not classified as per the CLP regulation.

Executive summary:

Acute oral toxicity study of the given test chemical was conducted as per OECD No. 423 in rats.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, food was withheld but drinking water providedad 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 one mortality was observed on day 0 post dosing so another three animals of the same group were dosed with 2000 mg/kg body weight and again 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. MeanBody 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.At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationwas observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes and 1 hour, lethargy at 2 to 4 hours,Salivationat 3 and 4 hours and was found dead at 4 hours on day 0. Animal no. 4 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationat 4 hours and normal from day 1 till termination. Animal no. 5 was observed normal at 30 minutes and 1 hour , lethargy at 2, 3, 4 hours and on day 1,Salivationat 4 hours and found dead on day 1. Animal no. 6 was observed normal at 30 minutes to 2 hour, lethargy at 3 and 4 hours and was normal from day 1 to till termination.During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen.During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion was observed in animal no. 5.Under the conditions of this;the acute oral LD50(Cut-off value) of test chemical was  2500 mg/kgbody weight.Thus considering the CLP criteria for classification it is concluded that the test substance is non toxic via oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

K1 level data obtained from experimental results.

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

Endpoint conclusion:

no adverse effect observed

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 test result performed using standard test guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The objective of the study was to assess the dermal toxicity of test chemical after single 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 or test system and environmental conditions:

Species:Rat (Rattus norvegicus)
Strain:Wistar
Sex:Male and Female
Number of Animals:10 (Five per sex)
Supplier/Source:In-House Bred
Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant
Body weight of animals:
-Male:Minimum: 273 g and Maximum: 280 g (Prior to Treatment)
-Female:Minimum: 236 g and Maximum: 250 g
Acclimatisation:All animals were acclimatized to the test conditions for 8 days prior to test item application.
Identification:During Acclimatization, animals were marked temporary by permanent marker, on their tails. After acclimatization, the animals were marked by 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.
Randomization:Animals were selected manually. No computer generated randomization program was used.
Husbandry ConditionsDiet:All animals were provided conventional laboratory rodent diet Bedding:All cages were provided with corn cobs
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: 19.60 °C Maximum: 21.40 °C
Relative humidity:Minimum: 47.40% Maximum: 58.60%
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:

Preparation of Application SiteApproximately 24 h prior to treatment, the fur of dorsal area of the trunk (greater than 10% body surface area) of rats was clipped by using clipperTest Item Application ProcedureThe test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with an amount of test item moistened with 0.2 ml distilled water. 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 12:45 to 12:58 p.m.Limit TestFive 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)-2000 mg/kg bw

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 TestFive 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.

Statistics:

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: At 2000 mg/kg, all the animals were normal throughout the experimental period.

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:

other: At 2000 mg/kg, all the animals were observed normal throughout the experimental period (refer table 2).

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                                                                                                         

Animal No.	Sex	Body Weight (gram)			Body Weight Change (%)
		Day 0	Day 7	Day 14	Day 0-7	Day 0-14
1	Male	277	282	289	1.81	4.33
2		274	295	315	7.66	14.96
3		280	296	319	5.71	13.93
4		273	286	312	4.76	14.29
5		277	292	309	5.42	11.55
6	Female	236	238	241	0.85	2.12
7		241	245	248	1.66	2.90
8		236	238	241	0.85	2.12
9		237	241	242	1.69	2.11
10		250	256	258	2.40	3.20

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

Key: 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	276.20	290.20	308.80	5.07	11.81
	SD	2.77	6.02	11.67	2.12	4.37
	n	5	5	5	5	5
Female	Mean	240.00	243.60	246.00	1.49	2.49
	SD	5.96	7.50	7.31	0.66	0.52
	n	5	5	5	5	5

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

Interpretation of results:

practically nontoxic

Conclusions:

Under the condition of study; acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Executive summary:

Acute Dermal Toxicity Study of test chemicalinWistar Rats 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. Ratsfree from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 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, anamount oftestitem 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.The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period.At 2000 mg/kg, all the animals were normal throughout the experimental period.Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0 The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Under the conditions of the study,the acute dermal median lethal dose oftest chemicalwas> 2000 mg/kgbody weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1 level data obtained from experimental results.

Additional information

Acute toxicity: oral

Acute oral toxicity study of the given test chemical was conducted as per OECD No. 423 in rats.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, food was withheld but drinking water providedad 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 one mortality was observed on day 0 post dosing so another three animals of the same group were dosed with 2000 mg/kg body weight and again 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. MeanBody 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.At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationwas observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes and 1 hour, lethargy at 2 to 4 hours,Salivationat 3 and 4 hours and was found dead at 4 hours on day 0. Animal no. 4 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationat 4 hours and normal from day 1 till termination. Animal no. 5 was observed normal at 30 minutes and 1 hour , lethargy at 2, 3, 4 hours and on day 1,Salivationat 4 hours and found dead on day 1. Animal no. 6 was observed normal at 30 minutes to 2 hour, lethargy at 3 and 4 hours and was normal from day 1 to till termination.During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen.During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion was observed in animal no. 5.Under the conditions of this;the acute oral LD50(Cut-off value) of test chemical was  2500 mg/kgbody weight.Thus considering the CLP criteria for classification it is concluded that the test substance is non toxic via oral route.

Acute toxicity:Inahalation:

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 substance, High melting point, which is reported as 685°C; Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of range 225 micrometer to 500 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  

Acute toxicity: dermal

Acute Dermal Toxicity Study of test chemicalinWistar Rats 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. Ratsfree from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 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, anamount oftestitem 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.The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period.At 2000 mg/kg, all the animals were normal throughout the experimental period.Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0 The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Under the conditions of the study,the acute dermal median lethal dose oftest chemicalwas> 2000 mg/kgbody weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Justification for classification or non-classification

Based upon the studies reviewed it can be concluded that, the test chemical is not expected to show acute toxicity effect by the oral, inhalation and dermal route and thus will not be considered for further classification.