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Diss Factsheets

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
Justification for type of information:
Data is from study report.

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 the given test chemical after single oral administration in rats.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl phenylacetate
EC Number:
202-940-9
EC Name:
Methyl phenylacetate
Cas Number:
101-41-7
Molecular formula:
C9H10O2
IUPAC Name:
methyl phenylacetate
Details on test material:
- Name of test material (as cited in study report): Methyl phenyl acetate
- Molecular formula : C9H10O2
- Molecular weight : 150.177 g/mole
- Substance type:Organic
- Physical state: liquid
- Analytical purity: 99.42 %
- Lot/batch No.: 2012051201
- Storage condition of test material: Room temperature (20° - 30 °C)
- Other: Handling and Disposal - Safety precautions: Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the Personnel
Disposal:The remaining unused test item formulations were disposed as per internal SOPs of sa-FORD.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:In-house animals, bred at Animal House, sa-FORD.
- 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: 144 g and Maximum: 169 g (Individual body weights were within ± 5 % prior to treatment after overnight
fasting)
- Fasting period: The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing.
- Housing: The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs SPAR – 26 /2014 and SPAR – 27 /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.: 400010.
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:Animal nos. 1-3 were acclimatized for 7 days and 4-6 for 9 days, prior to administration of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.60 °C and Maximum: 21.40 °C.
- Humidity (%):Minimum: 47.40 % and Maximum: 58.60%.
- Air changes (per hr):More than 12 changes per hour.
- Photoperiod (hrs dark / hrs light):12:12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle (if gavage):10 ml/kg bw

DOSAGE PREPARATION (if unusual): Added slowly vehicle in the test item and mixed well. Transfrred the formulation to the measuring cylinder and made the volume upto desired quantity of 10 ml. the dosing solution was prepared freshly,shortly prior to dose administration.
Doses:
G1 = 2000 mg/kg
G2 = 2000 mg/kg
No. of animals per sex per dose:
6 female rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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 surviving rats were weighed on days 0 (prior to dosing), 7 and 14.
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2. All the animals were observed for external and internal gross pathology.
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 in the animals treated with 2000 mg/kg dose throught out the 14 days observation period.
Clinical signs:
other: At 2000 mg/kg, all the animals were normal throughout the experimental period.
Gross pathology:
No external and internal gross pathological changes were seen in all the six animals treated with 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/ 2000

169

205

212

21.30

25.44

2

156

181

197

16.03

26.28

3

158

192

214

21.52

35.44

4

144

169

178

17.36

23.61

5

157

199

205

26.75

30.57

6

149

175

184

17.45

23.49

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

155.50

186.83

198.33

20.07

27.47

SD

8.55

14.12

14.81

3.97

4.68

n

6

6

6

6

6

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

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

 

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

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

Keys:1 = Normal


Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
Under the conditions of this; acute oral toxicity dose was considered to be >2000 mg/kg bw, when female rats were treated with the given test chemical via oral gavage route.
Executive summary:

Acute oral toxicity study was conducted for the given test chemical as per OECD No. 423 (Acute Oral toxicity - Acute Toxic Class Method) in female Wistar 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 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 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 all the 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, all the animals were normal throughout the experimental period. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.

Under the conditions of this; acute oral toxicity dose was considered to be >2000 mg/kg bw, when female rats were treated with the given test chemical via oral gavage route.