Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated

Endpoint summary

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different experimental study report and other studies conducted on rats and mice 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 study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.In accordance with column 2 of Annex VIII, this end point was considered for waiver since the vapour pressure of test chemical is low and so exposure by the inhalation route is unlikely.

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different experimental study reports conducted on rats for the test chemical. The studies 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:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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
- Source:Bharat Serum and Vaccines Limited, India.
- Age at study initiation:8- 10 weeks at the time of dosing.
- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight at study initiation:Minimum: 134 g Maximum: 165 g (Individual body weights were within ± 7% prior to treatment after overnight fasting)
- Fasting period:The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing.
- Housing:The animals were housed individually in polycarbonate cages..
- Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 25/2014
- 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):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:Animal nos. Animal nos. 1-3 were acclimatized for 5 days, 4-6 for 9 days, 7-9 for 14 days and 10-12 for 5 days, prior to administration of the test item
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.30 °C Maximum: 23.20 °C
- Humidity (%):Minimum: Minimum: 48.60% Maximum: 69.20%.
- Air changes (per hr):More than 12 changes per hour.
- Photoperiod (hrs dark / hrs light):12:12

Route of administration:

oral: unspecified

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage):10 ml
- Justification for choice of vehicle:N/A
- Lot/batch no. (if required):N/A
- Purity:N/A

MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight.

Doses:

G1 = 300 mg/kg bw
G2 = 2000 mg/kg bw

No. of animals per sex per dose:

12 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
At the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2 for external and internal observations.
- 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 the surviving animals were observed once a day during the 14 day observation period.

Body weight:
All surviving rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.

other:
Mortality:
All surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.

Statistics:

not specified

Preliminary study:

not specified

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

No mortality was observed througout the experimentation period

Clinical signs:

other: At 300 and 2000 mg/kg, all the animals were observed with normal clinical sign till day 14.

Gross pathology:

No external and internal gross pathological examination were seen in all the animals treated with 300 and 2000 mg/kg body weight during terminal sacrifice .

Other findings:

not specified

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	Day 0-7	Day 0-14
1	G1/ 300	138	168	187	21.74	35.51
2		139	175	186	25.90	33.81
3		144	183	203	27.08	40.97
4		145	176	191	21.38	31.72
5		152	185	205	21.71	34.87
6		149	180	190	20.81	27.52
7	G2/ 2000	160	185	199	15.63	24.38
8		165	189	203	14.55	23.03
9		156	192	200	23.08	28.21
10		134	174	192	29.85	43.28
11		138	169	179	22.46	29.71
12		141	178	195	26.24	38.30

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/ 300	Mean	144.50	177.83	193.67	23.10	34.07
	SD	5.47	6.18	8.24	2.67	4.45
	n	6	6	6	6	6
G2/ 2000	Mean	149.00	181.17	194.67	21.97	31.15
	SD	12.93	8.98	8.59	5.95	8.01
	n	6	6	6	6	6

Keys:- = Not Applicable, 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/ 300	1	1	1	1	1
2		1	1	1	1	1
3		1	1	1	1	1
4		1	1	1	1	1
5		1	1	1	1	1
6		1	1	1	1	1
7	G2/ 2000	1	1	1	1	1
8		1	1	1	1	1
9		1	1	1	1	1
10		1	1	1	1	1
11		1	1	1	1	1
12		1	1	1	1	1

 

Keys:- = Not applicable,

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/ 300	1	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		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		1	1	1	1	1	1	1	1	1	1	1	1	1	1
6		1	1	1	1	1	1	1	1	1	1	1	1	1	1
7	G2/ 2000	1	1	1	1	1	1	1	1	1	1	1	1	1	1
8		1	1	1	1	1	1	1	1	1	1	1	1	1	1
9		1	1	1	1	1	1	1	1	1	1	1	1	1	1
10		1	1	1	1	1	1	1	1	1	1	1	1	1	1
11		1	1	1	1	1	1	1	1	1	1	1	1	1	1
12		1	1	1	1	1	1	1	1	1	1	1	1	1	1

Key:1 = Normal

Interpretation of results:

other: not classified

Conclusions:

The lethal concentration LD50 value for acute oral toxicity test was considered to be >2000 mg/kg bw,when female wistar rats were treated with test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Executive summary:

Acute Oral Toxicity Study of test chemical in female wistar Rats.This study was performed as per OECD Guideline No. 423. Twelve 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 providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 300 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 300 mg/kg weight and no mortality was observed.Hence, three rats of group G2 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed.Hence, further dosing was stopped.Body weights were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of animals treated with 300 and 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.At 300 and 2000 mg/kg, all the animals were observed with normal clinical sign till day 14.No external and internal gross pathological examination were seen in all the animals treated with 300 and 2000 mg/kg body weight during terminal sacrifice.The acute oral LD50 value of test chemical was >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 Unclassified” criteria of CLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 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:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

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:

Data is from experimental study report

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:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation:N/A
- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight (Prior to Treatment):Male:Minimum: 224 g and Maximum: 276 g Female:Minimum: 231 g and Maximum: 245 g
- Fasting period before study:N/A
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding : All cages were provided with corn cobs.
- 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):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) 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 5 days prior to administration of the test item..
- Randomization : Animals were selected manually. No computer generated randomization program was used

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.80 °C Maximum: 22.90 °C
- Humidity (%):Minimum: 48.60% Maximum: 60.90%
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

Type of coverage:

semiocclusive

Vehicle:

other: distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure:The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage:Approximately 10% body surface area of rat.
- Type of wrap if used:The porous gauze dressing and non-irritating tape.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A limit dose of 2000 mg/ kg body weight of test item was applied.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A

Duration of exposure:

24 hrs

Doses:

2000 mg/kg body weight.

No. of animals per sex per dose:

10 (Five per sex)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
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.
- Other examinations performed:
- Clinical signs :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 periodd.

- Body weight: All rats were weighed on days 0 (prior to dosing), 7 and 14
other:
- Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs

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

Statistics:

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

Preliminary study:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: nomortality was observed

Mortality:

No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period

Clinical signs:

other: All the animals were observed with normal clinical signs throughout the experimental period

Gross pathology:

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality

Other findings:

not specified

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

 

Dose:2000 mg/ kg bodyweight     

Density:1.1167

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	0.48	267	278	302	4.12	13.11
2		0.49	276	281	298	1.81	7.97
3		0.47	265	281	306	6.04	15.47
4		0.40	224	254	287	13.39	28.13
5		0.46	259	274	292	5.79	12.74
6	Female	0.41	233	230	239	-1.29	2.58
7		0.44	245	245	248	0.00	1.22
8		0.42	237	247	256	4.22	8.02
9		0.41	231	234	237	1.30	2.60
10		0.43	240	232	248	-3.33	3.33

                                                                                                    

Keys:* = Based on day 0 body weight taken prior to dose application.

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

Interpretation of results:

other: not classified

Conclusions:

The LD50 value was considered to be >2000 mg/kg bw,when male and female wistar rats were semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).

Executive summary:

Acute Dermal Toxicity Study of test chemial in Wistar Rats at dose concentration of 2000 mg/kg bw. This study was performed as per OECD Guideline 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 (1.1167) 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. The animals were observed daily for mortality and clinical signs, during the acclimatization period. 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.All the animals were observed with normal clinical signs throughout the experimental period.In both males and females, mean body weight was observed with increase 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. The acute dermal LD50 value of test chemical was >2000 mg/kg body weight.Thus by considering it infers that test chemial does not exhibit acute dermal toxicity as per CLP criteria of classification.

 

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 experimental study 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 –

Acute Oral Toxicity Study of test chemical in female wistar Rats.This study was performed as per OECD Guideline No. 423. Twelve 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 providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 300 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 300 mg/kg weight and no mortality was observed.Hence, three rats of group G2 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed.Hence, further dosing was stopped.Body weights were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of animals treated with 300 and 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.At 300 and 2000 mg/kg, all the animals were observed with normal clinical sign till day 14.No external and internal gross pathological examination were seen in all the animals treated with 300 and 2000 mg/kg body weight during terminal sacrifice.The acute oral LD50 value of test chemical was >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 Unclassified” criteria of CLP.

The above study is supported with another study mentioned in publication and conducted on mice for the test chemical. Acute oral toxicity study was performed in rats using test chemical at dose concentration of 47000 mg/kg bw.50% mortality was observed at dose 47000 mg/kg bw. Hence,LD50 value was considered to be 47000 mg/kg bw,when mouse were treated with test chemical orally.

Both the above studies are further supported with the study mentioned in publication for the test chemical. Acute oral toxicity study was performed in male albino rats using test chemical at dose concentration of 30200 mg/kg bw.50% mortality was observed at dose 30200 mg/kg bw. Hence,LD50 value was considered to be 30200 mg/kg bw,when male albino rats were treated with test chemical orally.

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 oral toxicity.

 

Acute Inhalation Toxicity:

The study need not be conducted because exposure of humans via inhalation is not likely taking intoaccount the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.In accordance with column 2 of Annex VIII, this end point was considered for waiver since the vapour pressure of test chemical is low and so exposure by the inhalation route is unlikely.

 

Acute Dermal Toxicity:

In different experimental studies, the given test chemical has been investigated for acute dermal toxicity. The studies are based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below -

Acute Dermal Toxicity Study of test chemial in Wistar Rats at dose concentration of 2000 mg/kg bw. This study was performed as per OECD Guideline 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 (1.1167) 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. The animals were observed daily for mortality and clinical signs, during the acclimatization period. 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.All the animals were observed with normal clinical signs throughout the experimental period.In both males and females, mean body weight was observed with increase 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. The acute dermal LD50 value of test chemical was >2000 mg/kg body weight.Thus by considering it infers that test chemial does not exhibit acute dermal toxicity as per CLP criteria of classification.

In acute dermal toxicity study, group of 5 male and female wistar rats were treated with test chemical in the concentration of 2000 mg/kg bw by dermal application.water was used as vehicle.No mortality was observed in treated rats at dose 2000 mg/kg bw. The test chemical at the dose level of 2000 mg/kg body weight did not elicit any clinical signs of intoxication throughout the period of observation. The body weight of all the animals was recorded on day 0th and then 7th and 14th (post treatment) showed normal increase in body weight as compared to control group.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rats were treated with test chemical by dermal application.  

The above study is supported with another study conducted on rats for the test chemical. The study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to male and female Sprague Dawley rats 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 toxicity by the dermal route.

Thus, based on the above summarised experimental 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 LD50 value is greater than 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 be for acute oral toxicity and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.