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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 experimental 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 given 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

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecan-5-olide
EC Number:
211-932-4
EC Name:
Dodecan-5-olide
Cas Number:
713-95-1
Molecular formula:
C12H22O2
IUPAC Name:
6-heptyloxan-2-one
Test material form:
liquid
Details on test material:
- Name of the test material: Dodecan 5- olide
- Molecular formula: C12H22O2
- Molecular weight: 198.31 g/mol
- Smiles: CCCCCCCC1CCCC(=O)O1
- Inchi: 1S/C12H22O2/c1-2-3-4-5-6-8-11-9-7-10-12(13)14-11/h11H,2-10H2,1H3
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: In-House Bred
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8- 10 weeks at the time of dosing. Healthy young adult animals were used for the study.
- Weight at study initiation: Minimum: 135 g Maximum: 152 g (Individual body weights were within ± 5% prior to treatment after overnight fasting)
- Fasting period before 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.
- 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, ad libitum
- 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 5 days and 4-6 for 10 days.
- 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.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.30°C Maximum: 23.20°C
- Humidity (%): Minimum: 48.70 % Maximum: 64.20 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: 28 april 2014 to 23rd june 2014

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
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: Corn oil was selected as a vehicle because test item was not soluble in the distilled water during solubility testing.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw-06 Females
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 surviving rats were euthanised by overdose of CO2. All the animals were subjected 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.
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

Results and discussion

Preliminary study:
not specified
Effect levels
Key result
Sex:
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 were observed throughout the experimentation period
Clinical signs:
other: At 2000 mg/kg, all the six animals were observed with normal clinical sign till day 14.
Gross pathology:
No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifies.
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 (%)

 

G1/2000

Day 0

Day 7

Day 14

Day

0-7

Day

0-14

1

142

173

186

21.83

30.99

2

137

168

177

22.63

29.20

3

135

156

176

15.56

30.37

4

149

180

194

20.81

30.20

5

152

178

185

17.11

21.71

6

144

162

171

12.50

18.75

 

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

14317

169.50

181.50

18.40

26.87

SD

6.62

9.33

8.36

4.00

5.26

n

6

6

6

6

6

Key: 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

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

No mortality and morbidity

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

Terminal sacrifice

No abnormality detected

No abnormality detected

6

Terminal sacrifice

No abnormality detected

No abnormality detected

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral LD50 value of 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 exhibits acute oral toxicity and thus not classified.
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, 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 group G1 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 were observed. Hence further dosing was stopped. Body weight were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of animals treated with 2000 mg/kg body weight were observed with gain on day 7 and 14, when compare to day 0. At 2000 mg/kg all the six animals were observed with normal clinical sign till day 14. No external and internal gross pathlogical examination were seen in all six animals treated with 2000 mg.kg body weight during terminal sacrifice.

Under the conditions of this, the acute oral LD50 value of 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 exhibits acute oral toxicity and thus not classified.