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Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
EC Number:
500-038-2
EC Name:
Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
Cas Number:
25322-68-3
Molecular formula:
(C2-H4-O)mult-H2-O
IUPAC Name:
ethane-1,2-diol
Details on test material:
- Name of test material (as cited in study report): Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Molecular formula :(C2-H4-O)mult-H2-O
- Molecular weight :44.0526 g/mol
- Substance type: organic
- Appearance: Colourless clear liquid
- Physical state: Liquid

Test animals

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

Administration / exposure

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

Results and discussion

Preliminary study:
not specified
Effect levels
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:
At 300 and 2000 mg/kg, all the animals were observed with normal clinical sign till day 14.
Body weight:
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 .
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

Any other information on results incl. tables

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


Applicant's summary and conclusion

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.