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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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 4thhour 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 cm(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.

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