Fatty acids, C18-unsatd., reaction products with ammonia-ethanolamine reaction by-products

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Berolamine 715. Guideline, GLP principles

Cross-reference

Reason / purpose for cross-reference:

reference to same 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

Remarks:

According to GLP principles (Statement SD, QA audit)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products

EC Number:

629-757-0

Cas Number:

1224966-15-7

Molecular formula:

UVCB, no structural formula can be set

IUPAC Name:

Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products

Details on test material:

The test material was in the form of a dark brown viscous liquid and was stored in the dark under ambient conditions. The pH value for the test substance was 11.2.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Cheshire Rabbit Farms
- Age at study initiation: no data
- Weight at study initiation: 2.5-3.0 kg
- Housing: housed individually in cages with a grid floor beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): Special Diet Services Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 (15-19)
- Humidity (%): 46 (30-60)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml

Duration of treatment / exposure:

Single intillation, no flushing.

Observation period (in vivo):

The eyes were examined for irritation using standard illumination, unable to use fluorescein stain due to severe chemosis. The ocular reaction was recorded at one and 24 h at 24h it was decided to sacrifice the animals due to the severity of the observed effects.

Number of animals or in vitro replicates:

3 male and 3 female animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: as described in OECD405

TOOL USED TO ASSESS SCORE: standard illumination, unable to use fluorescein stain due to severe chemosis

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Time point:

other: 24h

Score:

> 2 - < 4

Max. score:

4

Reversibility:

not reversible

Remarks:

animals were killed after 24h for humane reasons

Irritant / corrosive response data:

Cornea
Dullness of the cornea was noted in all treated eyes 1 h and 24 h after instillation. Severe chemosis prevented the use of fluorescein stain to
assess opacity although it was noted that no obvious opacity was apparent.
Iris
Positive iridial responses (score 1-2) were noted in one treated eye at 1 h, and in all treated eyes at 24 h after instillation.

Conjunctivae
Redness
Positive redness (score 2) was noted in 5/6 treated eyes and the remaining animal showed slight redness (score 1) at 1 h post instillation. All treated eyes showed positive responses (score 2) at 24h.
Chemosis
Severe chemosis (score 3-4) was noted in all treated eyes at 1 h and 24 h.
Discharge
Moderate discharge was noted in all treated eyes at 1 h post instillation. Severe thick white discharge was noted in all treated eyes at 24 h.

No other non-ocular topical effects were noted at any time during the test.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test substance was extremely irritant to the eye in the rabbit irritation test. The test was terminated after 24h for humane reasons.

Executive summary:

The test substance was extremely irritant to the eyes of 3 male and 3 female rabbits after single instillation of 0.1 ml. The test was terminated after 24h for humane reasons.