Tetradecan-1-ol, propoxylated, esters with propionic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 14, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: Eye Irritation Test

Version / remarks:

Method used by J. H. Draize in Appraisal of the Safety of Chemicals in Food, Drugs, and Cosmetics, compiled by the staff of the Division of Pharmacology, Food, and Drug Administration - Department of Health, Education, and Welfare

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Scale of Weighted Scores for Grading the Severity of Ocular Lesions

Version / remarks:

Standard score system from Draize, J. H., Woodward, G. and Calvery, H. O (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. Journal of Pharmacology and Experimental Therapeutics, 82 (3), 377-390

Principles of method if other than guideline:

- Principle of test: To determine the extent of ocular irritation hazard from a particular substance in rabbits according to the Draize Rabbit Eye Test
- Short description of test conditions: Six healthy New Zealand rabbits of mixed sex that weighed 1.8 - 2.4 kg were used to determine the potential of PPG-2 myristyl ether propionate to induce irritation to eye mucosa. A single administration of 0.1 ml was applied to the right eye (the left served as a control) and the eyes were not washed for 24 hours. Observations took place on day 1, 2, and 3 and were extended up to 7 days where necessary. During this time, observations of injuries were made on the cornea, iris, and the bulbar and palpebral conjunctive. Readings were facilitated by hand-held lenses. A standard score system from 1 – 4 was used to quantify the severity of lesions (Draize et al. 1944)
- Parameters analysed / observed: Injury to the cornea and iris. These account for approximately 80 % of the total score because of their vital role in vision

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)

Molecular formula:

C23H46O4

IUPAC Name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)

Constituent 2

Reference substance name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)

Molecular formula:

C23H46O4

IUPAC Name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)

Constituent 3

Reference substance name:

Tetradecyl propionate

EC Number:

228-300-9

EC Name:

Tetradecyl propionate

Cas Number:

6221-95-0

Molecular formula:

C17H34O2

IUPAC Name:

tetradecyl propanoate

Constituent 4

Reference substance name:

PG-2 Tetradecan-1-ol

IUPAC Name:

PG-2 Tetradecan-1-ol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey (conditioned prior to use)
- Weight at study initiation: 1.8 - 2.4 kg
- Diet: Ad libitum with Wayne animal feed
- Water: Ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml instilled in the right eye

Duration of treatment / exposure:

The treated eyes of all rabbits remained unwashed for 24 hours

Observation period (in vivo):

Examinations were made on day 1, 2, and 3, and up to 7 days if required

Number of animals or in vitro replicates:

Six New Zealand rabbits of mixed sex

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: Treated eyes were washed after 24 hours

SCORING SYSTEM:
Cornea
- Cornea opacity (A) based on degree of density (area which is dense is taken for reading): Scattered or diffuse area, details of iris clearly visible - 1; easily discernible translucent areas, details of iris slightly obscured - 2; opalescent areas, no details of iris visible, size of pupil barely discernible - 3; opaque, iris invisible - 4
- Area of cornea involved (B): One-quarter (or less), but not zero - 1; greater than one-quarter, but less than one-half - 2; greater than one-half, but less than three-quarters - 3; greater than three-quarters, up to whole area - 4
- Score = A x B x 5, total maximum of 80

Iris
- Values (A), folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combinations of any thereof), iris still reacting to light: Sluggish reaction is positive - 1; no reaction to light haemorrhage, gross destruction (any or all of these) - 2
- Score = A x 5, total maximum of 10

Conjunctive
- Redness (A), refers to palpebral conjunctivae only: Vessels definitely injected above normal - 1; more diffuse, crimson red, individual vessels not easily discernible - 2; diffuse beefy red - 3
- Chemosis (B): Any swelling above normal (including nictitating membrane) - 1; obvious swelling with partial eversion of the lids - 2; swelling with lids about half-closed - 3; swelling with lids about half-closed to completely closed - 4
- Discharge (C): Any amount different from normal (does not include small amount observed in inner canthus of normal animals) - 1; discharge with moistening of the lids and hairs just adjacent to the lids - 2; discharge with moistening of the lids and hairs and considerable area around eye - 3
- Score equals (A + B + C) x 2, total maximum of 20

Note: The maximum total score is the sum of all scores obtained for the cornea, iris, and conjunctivae

TOOL USED TO ASSESS SCORE: Hand-held lenses

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Corneal opacity (A) plus area of cornea involved (B) score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

80

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Remarks:

Values (A)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness (A), chemosis (B) and discharge (C)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

20

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

110

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No sign of primary eye irritation was observed in the cornea, iris, or conjunctivae following application of PPG-2 myristyl ether propionate. This resulted in grading scores of 0 across all inspected ocular tissues, in all rabbits between day 0 and 3. Examination past this time point was not necessary.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following 24-hour exposure to PPG-2 myristyl ether propionate, the registered substance was determined not to be an ocular irritant under the conditions of this test.

Executive summary:

A study was performed using a modified version of the Rabbit Eye Test by J. H. Draize from the Appraisal of the Safety of Chemicals in Food, Drugs, and Cosmetics in conjunction with a standard score system to permit weighted grading of the severity of any ocular lesion (Draize et al. 1944). In this system, injuries to the cornea and iris account for approximately 80 % of the total score due to their vital role in vision. The test aimed to determine the eye irritation potential of PPG-2 myristyl ether propionate in New Zealand rabbits of mixed sex following a 0.1 ml single administration to the right eye mucosa. The treated eye was left unwashed for a 24-hour exposure period. The left eye served as a control. Observations of injuries to the cornea, iris, and bulbar and palpebral conjunctivae were scheduled on day 1, 2, and 3, up until day 7 where necessary. Accurate grading was facilitated by hand-held lenses. The maximum total score was the sum of all scores obtained for the cornea, iris, and conjunctivae. On day 1, 2, and 3, ocular irritation was not observed in any rabbit, resulting in a total score of 0 of 110. Examination of the treated eye past day 3 was not necessary. It can be concluded that PPG-2 myristyl ether propionate is not an ocular irritant based on the conditions of this test and classification is not required (CLP Regulation (EC) No. 1272/2008).