3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

Primary eye irritation study in rabbits

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 18 1992 to December 8 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

A study conducted under Good Laboratory Practice Standards (40 CFR) and conforming with internationally recognized protocols and in particular satisfying criteria of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and OECD Guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: The protocol satisfies the criteria established by the Federal Insecticide, Fungicide, and Ro denticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.

Deviations:

no

Principles of method if other than guideline:

Young adult, male and female New Zealand White rabbits were used. The test material was administered as received.

GLP compliance:

yes (incl. QA statement)

Remarks:

All aspects of this study, as defined in the Protocol and the Project Instruction Sheet, were conducted in accordance with Good Laboratory Practice Standards (40 CFR).

Test material

Test material information

Constituent 1

Reference substance name:

3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

EC Number:

242-149-6

EC Name:

3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Cas Number:

18268-70-7

Molecular formula:

C24H46O7

IUPAC Name:

3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Specific details on test material used for the study:

The test material was a clear, golden-yellow liquid and was stored at room temperature throughout the study in two clear, glass jars.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Young adult male and female New Zealand White rabbits were used. The animals were purchased from a U.S.D.A. approved supplier

All animals were acclimated to the laboratory for one day before use. Animals were housed singly in wire mesh suspension cages and were supplied PURINA LABORATORY RABBIT CHOW (or other comparable diet) and tap water ad libitum except for the withholding of food overnight prior to dosing. The animals were maintained in 12-hour light/12-hour dark cycles.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL undiluted

Duration of treatment / exposure:

The undiluted test material was placed into one eye of each rabbit. The untreated eye served as control.

Observation period (in vivo):

approximately 1 hour and at 24, 48 and 72 hours

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

The eyes were examined and graded for ocular reaction at approximately 1 hour and at 24, 48 and 72 hours after appliecation using the Draize method. Except for the 1 hour scoring, the eyes were scored again for corneal opacity intensity and area using fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Any other information on results incl. tables

Table 1: Primary Eye Irritation in Rabbits Following an Ocular Application of Test Material

Rabbit		Cornea		Iris	Conjunctivae			Total
Number	Hr/Day	(Opacity)	(Area)		Erythema	Swelling	Discharge	Score
1	1 hours	0	0	0	1	1	0	4
(male)	24 hours	0	0	0	1	0	0	2/2
	48 hours	0	0	0	0	0	0	0/0
	72 hours	0	0	0	0	0	0	0/0
Mean/An 1	(24,48 and 72 hr)	0.00		0.00	0.33	0.00
2	1 hours	0	0	0	2	2	0	8
(male)	24 hours	0	0	0	1	0	0	2/2
	48 hours	0	0	0	1	0	0	2/2
	72 hours	0	0	0	0	0	0	0/0
Mean/An 2	(24,48 and 72 hr)	0.00		0.00	0.67	0.00
3	1 hours	0	0	0	1	1	0	4
(male)	24 hours	0	0	0	0	0	0	0/0
	48 hours	0	0	0	0	0	0	0/0
	72 hours	0	0	0	0	0	0	0/0
Mean/An 3	(24,48 and 72 hr)	0.00		0.00	0.00	0.00
4	1 hours	0	0	0	2	2	0	8
(female)	24 hours	0	0	0	1	1	0	4/4
	48 hours	0	0	0	0	0	0	0/0
	72 hours	0	0	0	0	0	0	0/0
Mean/An 4	(24,48 and 72 hr)	0.00		0.00	0.33	0.33
5	1 hours	0	0	0	1	1	0	4
(female)	24 hours	0	0	0	1	0	0	2/2
	48 hours	0	0	0	0	0	0	0/0
	72 hours	0	0	0	0	0	0	0/0
Mean/An 5	(24,48 and 72 hr)	0.00		0.00	0.33	0.00
6	1 hours	0	0	0	1	1	0	4
(female)	24 hours	0	0	0	1	0	0	2/2
	48 hours	0	0	0	0	0	0	0/0
	72 hours	0	0	0	0	0	0	0/0
Mean/An 6	(24,48 and 72 hr)	0.00		0.00	0.33	0.00

The total score is the sum of the following three sub-totals, with a maximum score of 110; (/) = score without/with sodium fluorescein.

1. Decgree of opacity x area x 5

2. Iris score x 5

3. (Sum of scores for erythema, swelling and discharge) x 2

Applicant's summary and conclusion

Interpretation of results:

other: The undiluted test material is classified in Toxicity Category III (40 CFR 156.10) by ocular administration.

Conclusions:

The primary eye irritancy of undiluted test material was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.

The test material produced conjunctival irritation, which had cleared by 72 hour reading.

Maximum total irritation scores for individual animals ranged from 4 to 8.

There was no evidence of corrosion noted.

Based on mean scores following grading at 24, 48 and 72 hours after instillation of the test material, TegMeR(R) 804 would not be classified as an eye irritant due to the minimal sores observed for corneal opacity, iritis, conjunctival redness or conjunctival oedema.