Undec-10-enal

Acute Toxicity: dermal

Administrative data

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 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 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

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 was disposed as per internal SOPs of sa-FORD and the same was documented in the raw data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/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
- Weight at study initiation: Male: Minimum: 239 g and Maximum: 261 g and Female: Minimum: 207 g and Maximum: 229 g
- 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
- 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: All animals were acclimatized to the test conditions for 6 days prior to administration of the test item
- 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.
- Randomization: Animals were selected manually. No computer generated randomization program was used

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.80 °C and Maximum: 23.20 °C
- Humidity (%): Minimum: 48.60% and Maximum: 61.10%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approximately 10% body surface area
- Type of wrap if used: porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test item was removed by using distilled water.
- Time after start of exposure: 24 hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Individual rat was applied with an amount of test item, calculated based on the density (0.8417) and latest body weight
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes

VEHICLE: Not applicable

Duration of exposure:

24 hr

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Total: 10
2000 mg/Kg bw: 5/sex/dose

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 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 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
Animals were observed twice daily for any mortality during the experimental period.
Body weight
All rats were weighed on days 0 (prior to dosing), 7 and 14.
Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs).
Pathology
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

Statistics:

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

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

No mortality observed

Mortality:

No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period (refer table 3).

Clinical signs:

other: All the animals were observed with normal clinical signs throughout the experimental period (refer table 2).

Gross pathology:

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality (refer table 5).

Any other information on results incl. tables

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

 

Dose:2000 mg/ kg bodyweight                                                                              Density:0.8417

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	0.60	253	271	314	7.11	24.11
2		0.62	261	280	319	7.28	22.22
3		0.60	254	280	310	10.24	22.05
4		0.61	256	272	312	6.25	21.88
5		0.57	239	247	281	3.35	17.57
6	Female	0.49	207	206	217	-0.48	4.83
7		0.52	219	218	226	-0.46	3.20
8		0.50	212	221	226	4.25	6.60
9		0.54	226	221	234	-2.21	3.54
10		0.54	229	236	251	3.06	9.61

Key:* = based on density and day 0 body weight

Table 2: Individual Animal Clinical Signs and Symptoms

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

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

Table 4:Summary of Animal Body Weight (g) and Body Weight Changes (%)

Sex		Body Weight (gram)			Body Weight Changes (%)
		Day 0	Day 7	Day 14	Day 0-7	Day 0-14
Male	Mean	252.60	270.00	307.20	6.85	21.57
	SD	8.20	13.55	15.02	2.47	2.41
	n	5	5	5	5	5
Female	Mean	218.60	220.40	230.80	0.83	5.56
	SD	9.24	10.69	12.79	2.70	2.63
	n	5	5	5	5	5

Keys: SD= Standard deviation, n = Number of animals

Table 5: Gross Necropsy Observation

Mode of Death:Terminal Sacrifice

Animal No.	Sex	Gross Observation
		External	Internal
1	Male	No abnormalities detected	No abnormalities detected
2		No abnormalities detected	No abnormalities detected
3		No abnormalities detected	No abnormalities detected
4		No abnormalities detected	No abnormalities detected
5		No abnormalities detected	No abnormalities detected
6	Female	No abnormalities detected	No abnormalities detected
7		No abnormalities detected	No abnormalities detected
8		No abnormalities detected	No abnormalities detected
9		No abnormalities detected	No abnormalities detected
10		No abnormalities detected	No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight. Test chemical is being classified as non toxic by dermal exposure.

Executive summary:

Acute Dermal Toxicity Study of test chemical was performed inWistar Rats as per OECD No.402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. 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 (0.8417) 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 re¬corded 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. Mean body weight of both males and females were 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 median lethal dose of test chemical was found to be > 2000 mg/kg bw.