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Toxicological information

Eye irritation

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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

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 / 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

Resultsopen allclose all
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)
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)
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)
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)
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
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
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
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.

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