Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: F.D.A. Handbook Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics 1959 p.49

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

EC Number:

271-516-3

EC Name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

Cas Number:

68583-51-7

Molecular formula:

C21H44O6

IUPAC Name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no details available
- Age at study initiation: adults

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

1, 2, 3, 4 and 7 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: In three rabbits the treated eye remained unwashed, in three rabblts the treated eyes were washed.
- Time after start of exposure: 4 seconds after instillation with 20 mL lukewarm water

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: washed and unwashed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: washed and unwashed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: washed

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: unwashed

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: unwashed

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: unwashed

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: washed and unwashed

Irritant / corrosive response data:

The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris. Please refer to Tabel 1 for details.

Any other information on results incl. tables

Table 1: Details on results

			Cornea		Iris	Conjunctivae
	Animal	Day	Opacity	Area		Redness	Chemosis	Discharge
Unwashed	1	1	0	0	0	1	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	2	1	0	0	0	2	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	3	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
Washed	4	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	5	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	6	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The eye irritation was investigated on six rabbits. Only slight erythema of the conjunctivae were detected and failed to persist beyond 24 hours after administration.

Executive summary:

For the test on eye irritation six adult New Zealand white rabbits were used. A 0.1 ml sample of the test material was instilled into one eye of each rabbit, the contralateral eye remaining untreated as a control. In three rabbits the treated eye remained unwashed, in three rabblts the treated eyes were washed with 20 ml lukewarm water 4 seconds after instillation. Readings were made at 1, 2, 3, 4 and 7 days to assess the irritant effects on various parts of the eyes. These assessments were made according to the Draize scale. The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris.