Decan-5-olide

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 study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted: 28th July 2015

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decan-5-olide

EC Number:

211-889-1

EC Name:

Decan-5-olide

Cas Number:

705-86-2

Molecular formula:

C10H18O2

IUPAC Name:

6-pentyloxan-2-one

Test material form:

liquid

Details on test material:

Name : Decan-5-olide
Chemical Name (IUPAC) : Decan-5-olide
Molecular Formula : C10-H18-O2
Molecular Weight : 170.25
Origin : Organic
Physical state : Colourless liquid
Purity as per Certificate of Analysis : 97.2 %
Batch No. : P586
InChI: InChI=1S/C10H18O2/c1-2-3-4-6-9-7-5-8-10(11)12-9/h9H,2-8H2,1H3
Smiles : CCCCCC1CCCC(=O)O1

Specific details on test material used for the study:

Name : Decan-5-olide
Chemical Name (IUPAC) : Decan-5-olide
Molecular Formula : C10-H18-O2
Molecular Weight : 170.25
Origin : Organic
Physical state : Colourless liquid
Purity as per Certificate of Analysis : 97.2 %
Batch No. : P586
InChI: InChI=1S/C10H18O2/c1-2-3-4-6-9-7-5-8-10(11)12-9/h9H,2-8H2,1H3
Smiles : CCCCCC1CCCC(=O)O1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Eurofins Advinus limited, Bengaluru 560058
- Age at study initiation: 6 months
- Weight at study initiation: 2.6342 to 2.6772 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: Length 65 x Breadth 65 x Height 45 cm) with noryl shallow cage body and facil ities for pelleted food (Stainless steel feed hopper) and drinking water (750 Markrolon® bottle fitted with sipper tube) and noryl perforated raised shelf for en richment.
- Diet (e.g. ad libitum): ad libitum The animals were offered rabbit feed manufactured Krishna Valley Agro-tech LLP, MIDC Kupwad block, Sangli, Maharashtra.
- Water (e.g. ad libitum): The animals were provided deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on -line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India
- Acclimation period: After physical examination good healthy animals were selected for the experiment. One rabbit (RBb947) was acclimatized for six days while the other two (RBb948 and RBb949) rabbits were acclimatized for seven days under laboratory conditions after physical examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%): 65 to 66%
- Air changes (per hr): 13.3 to 14.3 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light, 12 hour dark cycle

IN-LIFE DATES: From:15 December 2021 To: 25 December 2021

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
- Concentration (if solution): N/A

VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Three male rabbits

Details on study design:

TEST SITE
- Area of exposure: Left side of the dorsolateral trunk surface
- % coverage: 6 cm X 6 cm
- Type of wrap if used: The cotton gauze of size approximately 6 cm2 (2 x 3 cm of 6 ply). Patches were secured to the body of the animal by an adhesive ta pe, and a crepe bandage was wrapped around the torso of the animal, which was anchored using safety pins.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The applied area was washed with de-ionized water to remove the residual test item.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS : The reactions were assessed at 1, 24, 48, 72 hours, post removal of test patches.

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

For Test item Treated area

Basis:

animal:

Remarks:

#1, #2 and #3

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Remarks:

For Test item Treated area

Basis:

animal:

Remarks:

#1, #2 and #3

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

For Control area

Basis:

animal:

Remarks:

#1, #2 and #3

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Remarks:

For Control area

Basis:

animal:

Remarks:

#1, #2 and #3

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Skin reaction were assessed at 1, 24, 48, 72 hours, post removal of the test patch.

Single animal: The test patches with the respective contact periods of 3 minutes, 1 hour and 4-hour were removed and flushed with de-ionized water and skin reaction was assessed immediately after washing of the respective control and treatment patches. The reactions were assessed at 1, 24, 48, 72 hours, post removal of test patches.
Additional two animals: Four hours after application, treated and control patches on the skin was removed and skin flushed with de-ionized water and skin reaction was assessed at 1, 24, 48, 72 hours, post removal of test patches.

Additional two animals: Four hours after application, treated and control patches on the skin was removed and skin flushed with de-ionized water and skin reaction was assessed at 1, 24, 48, 72 hours, post removal of test patches.

There were no skin reactions at 1, 24, 48, 72 hours, post removal of the test patch. The total mean score of skin reaction was 0 at 1, 24, 48, 72 hours respectively post removal of the test patch.

Other effects:

Clinical Signs and Pre-Terminal Deaths: There were no clinical signs and no pre-terminal deaths during the course of the experiment.

Body weights: The body weights of all the rabbits increased throughout the observation period.

Necropsy: There were no abnormalities at necropsy

Any other information on results incl. tables

IndividualBody Weights, Body Weight Change, Clinical Signs, Pre-terminal Deaths and Necropsy Findings

Rabbit No.	Sex	Body weights (kg)			Clinical signs*	Pre-terminal deaths	Necropsy findings
		At Treatment	At Termination	Body weight change#
RBb947	M	2.6342	2.6839	0.0497	N	Nil	NAD
RBb948	M	2.6716	2.6994	0.0278	N		NAD
RBb949	M	2.6772	2.7219	0.0447	N		NAD

M: Male    N: Normal         NAD: No Abnormality Detected     N: Normal     

*: Observation of clinical signs is applicable for throughout the experimental period.

#: [At Termination - At Treatment]

Individual Skin Reaction Scores:

Rabbit No.	Score	Application	Observations (post removal of the 4-hour test patch)
			1 hour	24 hours	48 hours	72 hours
RBb947*	Erythema	Control	0	0	0	0
		Treatment	0	0	0	0
	Edema	Control	0	0	0	0
		Treatment	0	0	0	0
RBb948	Erythema	Control	0	0	0	0
		Treatment	0	0	0	0
	Edema	Control	0	0	0	0
		Treatment	0	0	0	0
RBb949	Erythema	Control	0	0	0	0
		Treatment	0	0	0	0
	Edema	Control	0	0	0	0
		Treatment	0	0	0	0

0: No Erythema / No Edema       

 *: The responses (skin reactions) were assessed immediately after the removal of the test patches at 3 minutes, 1 hour and 4^thhour after application the score of erythema and edema was “0” and it indicated that the test item was not severely irritating or corrosive

Applicant's summary and conclusion

Interpretation of results:

other: Non-irritating

Conclusions:

Based on the present study results, the test item, DECAN-5-OLIDE (CAS: 725-86-2) is “Non-irritant” to the skin when tested in New Zealand White rabbits according to OECD 404 guideline.

Executive summary:

The acute skin irritation / corrosion study in New Zealand White Rabbits was conducted to evaluate the skin irritation potential of Decan-5-Olide according to OECD 404 guidline. Three healthy young adult male rabbits were used for the study. Body weights were recorded on day of treatment (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The fur on the left side of the dorsolateral trunk surface [about 19 x 14 cm] was clipped with an electric clipper, approximately 24 hours prior to treatment. A volume of 0.5 mL of the undiluted test item was applied in between the prepared area of the skin and the cotton gauze of size approximately 6 cm² (2 x 3 cm of 6 ply). A control patch (bare cotton gauze) was applied 3 – 4 cm anterior to the 4-hour test patch. All the patches were secured to the body of the animal by an adhesive tape, and a crepe bandage (except for 3 minutes patch) was wrapped around the torso of the animal. After 4 hours contact period, the treated area was washed with de-ionized water. The study was conducted in a stepwise manner (i.e., one rabbit for the initial test and two rabbits for the confirmatory test). The degree of irritation was evaluated at 1, 4, 24, 48 and 72 hours post removal of the test patch. The total mean score of skin reaction was 0 at 1, 24, 48, 72 hours respectively post removal of the test patch. There were no clinical signs and no pre-terminal deaths in any of the rabbits. No abnormalities were detected at necropsy.Based on the present study results,the test item,Decan-5-Olideis considered as“Non-irritant”to the skin of New Zealand White rabbits.