Registration Dossier

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

Constituent 1
Chemical structure
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.