Ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to the Test Guideline B.5 of the EEC Directive 84/449/EEC and OECD guideline N°405

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

404-740-9

EC Name:

-

Cas Number:

115895-09-5

Molecular formula:

C26H40Cl2O5

IUPAC Name:

ethyl 3,5-dichloro-4-{[(hexadecyloxy)carbonyl]oxy}benzoate

Details on test material:

A c. 700 g sample of the test substance was received from the sponsor on
September 19, 1988. It consisted of a fine, white powder, designated:
“AF-366”. Prior to application, the weight of 0.1 ml of the test substance
was assessed to be 0.071 g.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as the experimental
animals. The body weight range was 2670—3055 g. The animals ware
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front. The
cages ware placed in a room, controlled for light (12 hours light42 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water ware provided ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as the control

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.1ml (0.071g)

Duration of treatment / exposure:

at least 1 second
Single application without washing

Observation period (in vivo):

72 hours
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Irritant / corrosive response data:

Remains of the test substance were observed in the treated eye of 3/3 rabbits 1 hour after instillation, but disappeared within 24 hours. At the 1-hour reading time point, 3/3 rabbits had slight to moderate conjunctivae (redness) and slight chemosis. 24 and 48 hours after instillation, 2/3 rabbits still had slight conjunctivae and chemosis. All the eye irritation effects had cleared within 72 hours.

Any other information on results incl. tables

Table 1. Results of eye irritation study

 

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	1	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0
2	1	1	1	0	0
	24	1	1	0	0
	48	1	1	0	0
	72	0	0	0	0
	average	0.67	0.67	0.0	0.0
3	1	2	1	0	0
	24	1	1	0	0
	48	1	1	0	0
	72	0	0	0	0
	average	0.67	0.67	0.0	0.0

	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	1.33	1.00	0.00	0.00
	24	0.67	0.67	0.00	0.00
	48	0.67	0.67	0.00	0.00
	72	0.00	0.00	0.00	0.00
	24+48+72	0.45	0.45	0.00	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the resuits obtained it is concluded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Communities, L 257, Volume 26, 16
September 1983), the substance “AF—366” is not irritating or corrosive to
eyes.