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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from Sep. 24, 1984 to Nov. 15, 1984
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)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test substance: FAT 20'306/B
Batch No.: HT 2025/50
Physical properties: powder
Stability: guaranted by the sponsor for 30 years (2014)
Safety precautions: gloves and face masks
Test material received: July 5, 1984
Purity: approx. 96 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are 3 males.
- Animal Strain: New Zealand white rabbits (KFM-NZW)
- Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 degree centigrade
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): on a 12 hours light cycle day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g of FAT 20'306/B was placed into the conjunctival sac of the right eye of each animal
Duration of treatment / exposure:
no data
Observation period (in vivo):
The body weight was recorded at start and on day 3 and 7 of the test .
The animals were checked daily for systemic symptoms and mortality.
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
0.1 g of FAT 20'306/B was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control.

The ocular reactions were evaluated 24, 48, and 72 hours after the instillation of FAT 20'306/B according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.77
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
13
Irritant / corrosive response data:
Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 7 days to determine the reversibility of the eye reactions. The eye reactions observed were reversible until the end of the observation period on day 7.
Other effects:
No acute toxic symptoms were observed in the animal during the test period, and no morality occured. The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the condition of the test, test article shows only slight irritation to the rabbit eye.
Executive summary:

The test was performed to access the primary eye irritation potential. Three males were exposed a single dose of test substance (0.1 g per animal) placed in the eyes of rabbits. The reaction was assessed at 1-, 24-, 48- and 72-hours intervals after administration. No acute toxic symptoms were observed in the animal during the test period, and no morality occured. The mean values of the readings 24 to 72 hours after application are under the threshold of significance, thus it indicates that the test substance shall not be classified in accordance with CLP (Regulation EC 1272/2008).