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Toxicological information

Eye irritation

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Administrative data

eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from Dec. 11, 1996 to Jan. 28, 1997
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance test with GLP compliance

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guidelineopen allclose all
according to
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
according to
other: Directive 92/69 EEC, B.5. "Acute Toxicity - Eye Irritation” July 31, 1992.
GLP compliance:

Test material

Test material form:
other: solid
Details on test material:
Code number: FAT45'176/A
Batch No.: WP2/96
Purity: ca. 60 %
Appearance: orange-brown solid
Storage: room temperature
Expiration date: 11/2004

Test animals / tissue source

New Zealand White
Details on test animals or tissues and environmental conditions:
Age at treatment: 15 weeks
Body weight at start of treatment: male: 3.1 kg, females: 3.0 - 3.2 kg
Acclimatization: Four days under laboratory conditions after health examination. Only healthy animals were used for the study

Standard Laboratory Conditions,
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with target ranges for temperature of 20 ± 3 °C and for relative humidity between 40-70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.

Test system

unchanged (no vehicle)
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
one second
Observation period (in vivo):
Viability/Mortality: Daily
Clinical Signs: Daily during the observation period.
Body Weights: At the start of acclimatization, on the day of treatment and at termination of observation.
Irritation Scores: The eyes of each animal were examined for ocular irritation approximately 1, 24, 48 and 72 hours, as well as 7 and 14 days after administration.

Number of animals or in vitro replicates:
one male, two females
Details on study design:
The eyes of the animals were examined for intactness once, one day prior to test article administration. Only those animals with no signs of ocular injury or irritation were used on the test.
At treatment, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission Washington, D.C, 20207 was used for additional control purposes (Washington, 1977).

Results and discussion

In vivo

Irritation parameter:
overall irritation score
Time point:
other: 24, 48 and 72 hours
Irritant / corrosive response data:
FAT 45'176/A showed a primary irritation score of 0.00 when applied to the conjunctival sac of the rabbit eye.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
Short- to middle-term light orange staining of the cornea, conjunctivae and sclera were noted in all animals. Staining was reversible by day 14.
The body weight of the animals was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: EU
FAT45'176/A was not irritating to the rabbit eye.
Executive summary:

The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately1, 24, 48 and 72 hours as well as 7 and 14 days after test article application.

The scares of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.00 (max.13).

The test article FAT 45,176/A caused short-term swelling of the conjunctivae in one rabbit and increased lacrimation in all rabbits after one hour only. The test article caused light orange staining of various ocular structures, and was reversible after two weeks. Therefore, FAT45'176/A was not irritating to the rabbit eye.