Undec-10-enal

Acute Toxicity: oral

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

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 14 day observation period

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Undec-10-enal

EC Number:

203-973-1

EC Name:

Undec-10-enal

Cas Number:

112-45-8

Molecular formula:

C11H20O

IUPAC Name:

undec-10-enal

Test material form:

other: Clear Colorless liquid

Details on test material:

- Name of test material (as cited in study report): Undec-10-enal
- Molecular formula (if other than submission substance): C11H20O
- Molecular weight (if other than submission substance): 168.28 g/mol
- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 98.62%
- Lot/batch No.: KC/C11/1402070
- Expiration date of the lot/batch: July, 2014
- Storage condition of test material: Refrigerator (2 - 8 °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 and the same was documented in the raw data

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-House Bred at Sa-FORD, Animal Facility
- Health Status : Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Age at study initiation: 8- 10 weeks at the time of dosing
- Weight at study initiation: Minimum: 136 g and Maximum: 156 g (Individual body weights were within ± 5% prior to treatment after overnight fasting)
- Fasting period before study: Overnight
- Housing: The animals were housed individually in polycarbonate cages and
- Bedding: All cages were provided with corn cobs
- 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. 1-3 were acclimatized for 6 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
- 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
- Temperature (°C): Minimum: 19.80°C andMaximum: 23.20°C
- Humidity (%): Minimum: 48.60 % and Maximum: 63.20 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/Kg bw
- Amount of vehicle (if gavage): The maximum dose volume administered was 10 ml/kg body weight.
- Justification for choice of vehicle: Corn oil was selected as a vehicle because test item was not miscible in the distilled water during solubility testing
- Lot/batch no. (if required):
- Purity:

DOSAGE PREPARATION:
Added slowly vehicle in to the test item and mixed well. Transferred the formulation to the measuring cylinder and made the volume up to desired quantity. The dosing solution was prepared freshly, shortly prior to dose administration

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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 animals were observed once a day during the 14 day observation period. All rats were weighed on days 0 (prior to dosing), 7 and 14.
- 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 animals were observed once a day during the 14 day observation period.
Mortality
All 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.
Pathology
At the end of 14 day observation period, all rats were euthanised by overdose of CO2 for external and internal observations.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

No mortality observed

Mortality:

No mortality was observed througout the experimentation period. (refer table 4).

Clinical signs:

other: At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14 (refer table 3).

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 sacrifice (refer table 5).

Any other information on results incl. tables

Table 1: Individual Animal Body Weight (g) and Body 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	153	186	202	21.57	32.03
2		136	169	179	24.26	31.62
3		145	171	189	17.93	30.34
4		156	190	193	21.79	23.72
5		146	178	186	21.92	27.40
6		154	187	200	21.43	29.87

Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)

Group/ Dose (mg/kg)		Rats Body Weight (g)			Body Weight Changes (%)
		Day 0	Day 7	Day 14	0-7	0-14
G1/ 2000	Mean	148.33	180.17	191.50	21.48	29.16
	SD	7.50	8.84	8.69	2.03	3.13
	n	6	6	6	6	6

Keys:SD = Standard Deviation, n = Number of Animals.

Table 3: Individual Animal Clinical Signs and Symptoms

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

Table 4: Individual Animal Mortality Record

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

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:

Acute oral toxicity study of teswt chemical in female rats is as given below:
The acute oral LD50 was 5000 mg/kg body weight.Test chemical is being classified as non toxic by oral administration

Executive summary:

Acute oral toxicity study was conducted for the test compound in female Wistar rats as per OECD No. 423. 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 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 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0. At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14. No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.The acute oral LD₅₀of test chemical was5000 mg/kgbody weight.