Decan-5-olide

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 9th October 2017, Corrected 14 June 2021

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Livian Biolabs Pvt Ltd. Tumkur, Karnataka
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.6010 to 2.7128 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: L 65 x B 65 x H 45 cm) with noryl shallow cage body and facilities for pelleted f ood (Stainless steel feed hopper) and drinking water (750 mL Markrolon® bottle fitted with sipper tube). The perforated noryl raised shelf for enrichment wa s provided
- Diet (e.g. ad libitum): ad libitum, The animals were offered rabbit feed manufactured by Krishna Valley Agrotech LLP, MIDC Kupwad block, Sangli, Maharasht ra.
- Water (e.g. ad libitum): ad libitum, Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-c um-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India, was provided to animals in Markrolon® bottles with stainless steel sipper tubes
- Acclimation period: One rabbit (RBb950 was acclimatized for Six days while the other two rabbits (RBb951 and RBb952 were acclimatized for Seven days under laboratory conditions after physical examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%): 65 to 67 %
- Air changes (per hr): 14.3 air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light and 12 hour dark cycle

IN-LIFE DATES: From: 05 January 2022 To: 15 January 2022

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 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:

24 hours

Observation period (in vivo):

The rabbit used for the single animal test was observed for a period of 5 days and the additional two rabbits were observed for a period of 4 days post-instillation. The eyes of each rabbit were examined for ocular reaction at 1, 24, 48 and 72 hours post-instillation and scored.

Number of animals or in vitro replicates:

Three female rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye irrigated with normal saline for one minute to remove the residual test item.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

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

Remarks:

Untreated (control eye)

Results 2

Irritation parameter:

iris score

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

Remarks:

Untreated (control eye)

Results 3

Irritation parameter:

conjunctivae score

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

Remarks:

Untreated (control eye)

Results 4

Irritation parameter:

chemosis score

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

Remarks:

UNtreated (control eye)

Results 5

Irritation parameter:

cornea opacity score

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

Remarks:

Treated eye

Results 6

Irritation parameter:

iris score

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

Remarks:

Treated eye

Results 7

Irritation parameter:

conjunctivae score

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

Remarks:

Treated eye

Results 8

Irritation parameter:

chemosis score

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

Remarks:

Treated eye

Irritant / corrosive response data:

The rabbit used for the single animal test was observed for a period of 5 days and the additional two rabbits were observed for a period of 4 days post-instillation. The eyes of each rabbit were examined for ocular reaction at 1, 24, 48 and 72 hours post-instillation and scored.
The eyes of each rabbit were examined by using an ophthalmoscope at 1, 24, 48, 72 hours post-instillation and scored.

In addition, all the treated eyes were examined using ophthalmic fluorescein sodium at 24 hours post-instillation for all the three rabbits.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site)for corneal opacity, iris, conjunctiva and chemosis were found 0 respectively.

Other effects:

Clinical signs and pre-terminal deaths : There were no clinical signs of toxicity and pre-terminal deaths.

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

Necropsy : There was no abnormality detected in any of the animals at necropsy

Any other information on results incl. tables

Individual Body Weight, Clinical Signs and Necropsy Findings:

Animal No.

Body weight (kg)

Necropsy findings

Day 1

Day 2

Day 3

Day 4

Day 5

Sex

At Start of   Acclimatization

At Treatment

At Termination

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

RBb950

F

2..5681

2.6010

2.6840

N

N

N

N

N

N

N

N

N

N

NAD

RBb951

F

2.5937

2.6739

2.7486

N

N

N

N

N

N

N

N

-

-

NAD

RBb952

F

2.6385

2.7128

2.7912

N

N

N

N

N

N

N

N

-

-

NAD

NAD: No Abnormality Detected     F: Female  AM: Ante Meridian       PM: Post Meridian           h: hour        N: Normal

Note: There are no pre-terminal deaths

Individual Animals Eye Irritation Scores (Treated Eyes):

Rabbit Number	RBb950				RBb951				RBb952
Eye Reactions	Hour				Hour				Hour
	1	24	48	72	1	24	48	72	1	24	48	72
Corneal Opacity	0	0	0	0	0	0	0	0	0	0	0	0
Area of Opacity	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA
Iris	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctival Redness	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctival Chemosis	0	0	0	0	0	0	0	0	0	0	0	0

NA: Not applicable

Eye Irritation Scores - Mean Values of all Animals (Treated Eye):

Eye reaction	Hours
	1	24	48	72
Corneal Opacity	0	0	0	0
Area of Opacity	NA	NA	NA	NA
Iris	0	0	0	0
Conjunctival redness	0	0	0	0
Conjunctival chemosis	0	0	0	0

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:705-86-2) is “Non - irritant to Eyes” of the eye when tested in New Zealand white rabbits according to OECD 405 guideline.

Executive summary:

The acute eye irritation / corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation / corrosion potential of Decan-5-Olide (CAS:705 -86 -2): Acute Eye Irritation / Corrosion study in New Zealand White Rabbits" when a single dose of the test item was instilled into the conjunctival sac of the rabbit’s eye according to OECD 405 guideline. On test day one (treatment day), a volume of 0.1 mL of undiluted test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. All the rabbits were treated in a similar manner. The rabbit used for the single animal test was observed for a period of 5 days and the additional two rabbits were observed for a period of 4 days post-instillation. The eyes of each rabbit were examined examined by using an ophthalmoscope at 1, 24, 48 and 72 hours post-instillation and scored. The rabbits were observed for clinical signs and pre-terminal deaths twice daily with a minimum of 6 hours gap between observations on days 2 to 5/4. Body individual weights were recorded at the start of acclimatization, day 1 of treatment (prior to test item instillation) and at the termination of the observation period. The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site)for corneal opacity, iris, conjunctiva and chemosis were found 0 respectively. There were no clinical signs of toxicity and pre-terminal death, body weights of all rabbits increased during the observation periodand no abnormality was detected at necropsy.Based on the present study results the test itemDecan-5-Olideis“Non - irritant to Eyes”ofthe eye of New Zealand white rabbits.