Undec-10-enal

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:

D

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 405 (Acute Eye 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 on eye, when exposed by the ocular route in rabbits

GLP compliance:

not specified

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: December, 2014
- Storage condition of test material: Refrigerator (2 - 8 °C)
- Other:
Handling and Disposal
Safety precautions: Aprons, masks, caps, 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Procured from Sainath Agencies, Hyderabad
- Age at study initiation: 2.5 to 3.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.596 kg and Maximum: 1.748 kg
- Housing: The animals were housed individually in stainless steel cages
- 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
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 200005.
- 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 card was labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.60 °C and Maximum: 22.20 °C
- Humidity (%): Minimum: 56.50 % and Maximum: 69.20%
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

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: N/A

Duration of treatment / exposure:

24 hr

Observation period (in vivo):

72 hrs

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of rabbit was washed with normal saline
- Time after start of exposure: 24 hrs

SCORING SYSTEM: Grading of irritation lesions was carried out as per Draize Method

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

The following were observed in treated rabbits.
In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control.
Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hour.
The following grading scores were observed in treated eye of tested rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was observed in all the animals; Chemosis: No swelling (normal) was seen in all the animals.
Observation at 24, 48 and 72 hour after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Blood vessels normal in all the animals; Chemosis: No swelling (normal) was seen in all the animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in animal no. 1, 2 and 3.

Other effects:

Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period (Refer Table 2).
Mortality
No mortality was observed during the observation period.
Body weight
All the rabbits increased body weight at 72 hours (termination) as compared to day 0 (Refer Table 3).

Any other information on results incl. tables

Table 1 : Individual Animal Eye Irritation Scores

 

In Treated area Dose: 0.1 ml of test item (as such)                                               Sex:Female

Animal Numbers	1					2					3
Application Side	Right					Right					Right
Eye Reactions	At hour					At hour					At 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	0	0	0
Area of Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctiva	0	1	0	0	0	0	1	0	0	0	0	1	0	0	0
Chemosis	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Corneal Damage%	0%					0%					0%

Dose: Untreated (Control Eye)                                                                       Sex:Female

Animal Numbers	1					2					3
Application Side	Left					Left					Left
Eye Reactions	At hour					At hour					At 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	0	0	0
Area of Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctiva	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Chemosis	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Corneal Damage%	0%					0%					0%

Key:*= Pre-exposure eye examination

Table 1 (Continued): Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)

Animal No.  Eye Reaction	1	2	3
Corneal Opacity	0.00	0.00	0.00
Iris	0.00	0.00	0.00
Conjunctiva	0.00	0.00	0.00
Chemosis	0.00	0.00	0.00

Formula :

 

Mean Eye Irritation Score =

                          

Sum of the Individual Animal Score for eye reaction at 24, 48 and 72 hours

Number of the Observations (3)

Table 2: Individual Animal Clinical Signs

Animal No.	Days (Post application observation)
	0	1	2	3
1	1	1	1	1
2	1	1	1	1
3	1	1	1	1

Key:1 = Normal

Table 3: Individual Animal Body Weight

Animal No.	Animal Body Weight (kg)
	Prior to application	At termination
1	1.620	1.712
2	1.748	1.820
3	1.596	1.658

Key: kg = Kilogram

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of New Zealand White female rabbits was observed at 72 hours.
Hence, the test chemical can be considered as not irritating to the eyes of New Zealand White female rabbits.

Executive summary:

Acute Eye Irritation/Corrosion Study of test chemical in Rabbits was performed as per OECD guideline no. 405. Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas; 0.1 ml of test item was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hours after test item instillation. Ophthalmoscope was used for scoring of eye lesions.

In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions till 24 hour observation hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 which were recovered till 72 hours observation. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in animal no. 1, 2 and 3.

 The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes.