Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-05-08 to 1984-05-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

IUPAC Name:

Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL: Hostacerin DGS
- lot/batch No.of test material: E06-400 282 (Date of production 1983-10-25),
- Physical state /colour: white flakes
- Purity test date: about 100 % Diglycerindistearat-Oxethylat, small amount of free stearic acid and polyglycerin

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 22 °C
- Stability under test conditions: n.a.
- Solubility of the test substance in the solvent/vehicle: soluble in warmed-up fat

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: soluble in warmed-up fat

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: n.a.
- Weight at study initiation: 3.0 to 3.2 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 diet - Rabbit, Altromin GmbH, Lage /Lippe
- Water (e.g. ad libitum): deionized, chlorianted water, automated watering place
- Acclimation period: n.a.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): n.a.
- Photoperiod (hrs dark / hrs light): 12 hrs

Test system

Controls:

yes, concurrent no treatment

other: The other eye of each animal serves as untreated control

Amount / concentration applied:

0.1 mL of test item warmed up to about 40°C

Duration of treatment / exposure:

24 hours (24 hours after application the eyes were washed with physiological saline warmed up to 37°C)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes were washed with physiological saline warmed up to 37°C.
- Time after start of exposure: 24 hours after application

SCORING SYSTEM: DRAIZE

TOOL USED TO ASSESS SCORE: Fluorescein- Natrium-Solution (0.01 %); hand-slit lamp, examination of eys under UV-light.

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:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

One hour post application of test substance, diffuse to carmesin-red reddening and injected blood vessels were observed at the conjunctivae (one animal score 2, and two animals score 1). 24 hours post application all animals were free of any irritating signs.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this OECD 405 study, the test substance is not irritating to the eye.

Executive summary:

The test material was tested for primary eye irritation in three New Zealand albino rabbits according to OECD test guideline 405. 0.1 mL of undiluted test substance warmed up to about 40°C was applied once to the conjunctival sac of the left eyes of three rabbits. The untreated eye served as a respective control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which corneal examination with fluorescein sodium took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. One hour after treatment the conjunctivae of all animals showed some definitely injected blood vessels as well as a carmesin-red reddening. 24 hours after application all signs of irritation were reversible. The mean irrtation score was determined to be zero.