Diisopropyl adipate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Data is from experimental study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

To evaluate the acute eye irritation index of the test chemical in New Zealand White rabbit.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diisopropyl adipate

EC Number:

230-072-0

EC Name:

Diisopropyl adipate

Cas Number:

6938-94-9

Molecular formula:

C12H22O4

IUPAC Name:

1,6-bis(propan-2-yl) hexanedioate

Test material form:

other: Liquid

Details on test material:

-Name of the test material : Diisopropyl adipate
- Molecular formula (if other than submission substance): C12H22O4
- Molecular weight (if other than submission substance): 230.30g/mol
-Physical state : liquid
-Substance type : Organic

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:Institute for Industrial Research & Toxicology
- Age at study initiation:10 to 12 weeks
- Weight at study initiation:2.0kg ±200g
- Housing: Rabbit was housed singly in stainless steel cages provided with stainless steel mesh bottom
- Diet (e.g. ad libitum):Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi, India
- Water (e.g. ad libitum):Community tap water passed through ‘Aqua Guard on line water filter’ was kept in bottles, ad libitum
- Acclimation period: for 24 hours before study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 deg C
- Humidity (%): 40-60%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark.

IN-LIFE DATES: From: To: No data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye, which remains untreated, served as a control.

Amount / concentration applied:

A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which
remains untreated, serves as a control.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

21 days( 1, 24, 48 and 72 hours )

Number of animals or in vitro replicates:

3 female rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of the test animal did not wash for at least 24 hours following instillation of the test compound. At 24 hours a washout may be used if considered appropriate.
- Time after start of exposure: Afetr 24 hours. If required.

SCORING SYSTEM: Scale of weighted scores for grading the severity of ocular lesions developed by Draize et al
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: hand-slit lamp
Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the
observations at 24 hours, the eyes were further examined with the aid of fluorescein.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

other: not irritating

Irritant / corrosive response data:

In the confirmatory test, the test chemical when applied to the conjunctival sac of the rabbits in the amount of 0.1 ml, did not produce any eye irritation as well as eye discharge. Furthermore, there was no other clinical sign recorded in both of the animals during the whole observation period for 21 days.

Other effects:

Irritation Scoring:
The test chemical when applied to the eye of New Zealand white rabbit at the dose level of 0.1 ml did not produce any eye irritation. Furthermore, any lesions such as pannus, staining were not recorded throughout the observation period of 72 hours.
Clinical Signs:
The test chemical applied in conjunctival sac of rabbits at the dose level of 0.1 ml did not show any observable clinical signs such as cage side activity and pain or stress etc. throughout the observation period of 21 days.

Any other information on results incl. tables

TABLE- 1 GRADING OF OCULAR LESIONS

 

S.NO/ SEX		OBSERVATION	Score				Total	Total Score
1/F			1 hour	24hours	48 hours	72 hours
	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	0	0	0	0	0	0+0+0×5=0
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
2/F	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	0	0	0	0	0	0+0+0×5=0
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
3/F	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	0	0	0	0	0	0+0+0×5=0
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
Grand total								0.00
Mean								0.00
Eye Irritation Scoring index								0.00

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

In the confirmatory test, the test chemical when applied to the conjunctival sac of the rabbits in the amount of 0.1 ml, did not produce any eye irritation as well as eye discharge. Furthermore, there was no other clinical sign recorded in both of the animals during the whole observation period for 21 days.Based on above findings, it can be concluded that the test compound was not irritating when applied in
the amount of 0.1 gm in the conjunctival sac of the rabbits under test condition.

Executive summary:

Eye irritation study was conducted as per the OECD guideline 405 to evaluate the irritation potential of the test chemical. One healthy rabbit of body weight 2.4kg was selected for study after acclimatization. Both eyes of rabbits were examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound.The test chemical was applied in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball at the dose rate of0.1ml.The lids were then gently held for about one second in order to prevent loss of the material. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hoursafter the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed. The test chemical when applied to conjunctival sac of rabbit in the amount of 0.1ml did not produce any eye irritation during the observation period. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc. The result obtained from the initial test was confirmed in additional two animals of same sex and same dose level. In the confirmatory test the test compound was applied in the amount of 0.1 ml in the conjunctival sac of each rabbit after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hoursafter the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp.In the confirmatory test, the test chemical when applied to the conjunctival sac of the rabbits in the amount of 0.1 ml, did not produce any eye irritation as well as eye discharge. Furthermore, there was no other clinical sign recorded in both of the animals during the whole observation period for 21 days.Based on above findings, it can be concluded that the test compound was non-irritating when applied in the amount of 0.1 gm in the conjunctival sac of the rabbits under test condition.