Undec-10-enal

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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

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 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The objective of the study was to assess the irritant and/or corrosive effects of test chemical after dermal application on the intact skin in rabbits

GLP compliance:

yes (incl. QA statement)

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 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, caps, mask, 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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Procured from LIVEON BIOLABS PVT. LTD., Karnataka, 572106, (CPCSEA Reg. No. 1610/RO/bc12/CPCSEA).
- Sex: Male
- Health Status: Healthy young adults rabbits were used for the study.
- Age at study initiation: 4.0 to 4.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.888 kg and Maximum: 2.612
- Housing: The animals were housed individually in stainless steel cages
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No. 200004
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum
- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item
- Identification : During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage cards were labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment 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 minimum twice a week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.90 °C and Maximum: 22.50 °C
- Humidity (%): Minimum: 51.50 % and Maximum: 67.40 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE: Not applicable

Duration of treatment / exposure:

4-hour exposure period

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr

Control site: 0.5 ml distilled water was applied at control site.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2 and #3

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: at 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: at 24, 48 and 72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: at 24, 48 and 72 hours

Score:

1.67

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.

Other effects:

Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
Body weights were increased as compared to day 0 in all the three animals

Any other information on results incl. tables

Table 1: Skin Reaction

In Treated area Dose:0.5 ml of test item                                                                          Sex:Male

Animal No.	Test	Treated  area*	Erythema score					Oedema score
			1h	24h	48h	72h	Day 7	1h	24h	48h	72h	Day 7
1	Initial	Right	0	1	1	1	0	0	1	1	1	0
2	Confirmatory	Left	1	2	2	2	0	1	1	2	1	0
3		Left	1	2	2	2	0	1	1	2	2	0

In Control area  Dose: 0.5 ml of distilled water                Sex:Male

Animal No.	Test	Treated  area*	Erythema score					Oedema score
			1h	24h	48h	72h	Day 7	1h	24h	48h	72h	Day 7
1	Initial	Left	0	0	0	0	0	0	0	0	0	0
2	Confirmatory	Right	0	0	0	0	0	0	0	0	0	0
3		Right	0	0	0	0	0	0	0	0	0	0

Key: h = Hour.

Erythema                                                                               Oedema

0 =No erythema                                                                   0 =No oedema

1 =Very slight erythema (barely perceptible)                           1 =Very slight oedema (barely perceptible)

2 =Well defined erythema                                                    2 = Slight oedema (edges of area well defined by definite raising)

Mean Individual Animal Score at 24, 48 and 72 hours

Animal Number                   Observations	1	2	3
Erythema	1.00	2.00	2.00
Oedema	1.00	1.33	1.67

Table 2: Individual Animal Body Weight

Animal No.	Body Weight (kg)
	Prior to Dosing	At termination
1	1.888	2.048
2	2.184	2.210
3	2.612	2.648

Table 3: Individual AnimalClinical Signs

Animal No.	Days (Post dosing Observation)
	0	1	2	3	4	5	6	7
1	1	1	1	1	1	1	1	1
2	1	1	1	1	1	1	1	1
3	1	1	1	1	1	1	1	1

Key:1 = Normal

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.
Hence, it was concluded that the test chemical was Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.

Executive summary:

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits was performed as per the OECD guideline No. 404.Three healthy young adult male rabbits were used for conducting acute dermal irritation study. The hair of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A volume of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with cotton soaked in distilled water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch.

At 1 hour observation animal no. 1 revealed no erythema and no oedema. At 24 hour observation very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 and 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible)at 1 hour observation. At 24 hour observation animal no. 2 and 3 revealed well defined erythema and very slight oedema (barely perceptible).At 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible) and animal no. 3revealedwell defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3recovered to normal on day 7. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.

The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.  Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.