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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405. GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Alpine Rabbitry
-Sex/number: 12 females
- Age at study initiation: Approximately 12 weeks old
- Weight at study initiation: 1.7-2.3 kg
- Housing: individually
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-76 °F
- Humidity (%): 31 to 61 percent relative humidity
- Photoperiod (hrs dark / hrs light): 12hrs dark /12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
0.1 mL of the test article in a tuberculin syringe was dripped onto the surface of the right eye. The upper and lower lids were held closed for 1 -2 seconds
Observation period (in vivo):
Eyes were examined at prescreen, 24, 48, and 72 hours and day 4 following test article administration.
Number of animals or in vitro replicates:
12 females
Details on study design:
The right eye of each rabbit was treated in the following manner. The animal was removed from the cage and physically restrained. At this time 0.1 mL of the test article in a tuberculin syringe was dripped onto the surface of the right eye. The upper and lower lids were held closed for 1 -2 seconds. Six of the animals were not treated further. The test eyes of the remaining 6 animals were flushed for approximately 1 minute with lukewarm water beginning approximately 20 -30 seconds after dosing. The left eye remained untreated and served as a control eye.

Observations of ocular lesions were made at 24, 48, and 72 hours, and day 4. The eyes were examined and scored according to the Draize system (Draize, J.H., et al., 1965). In addition, flourescein examination of all eyes were made at prescreen, 24, 48, 72 hours and day 4.

All animals were sacrificed following the day 4 scoring period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48, and 72 hr average
Score:
ca. 0.2
Max. score:
0.3
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: unrinsed; max score at 24 and 48 hr; max possible score of 110
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
ca. 0.06
Max. score:
0.33
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: unrinsed; max score at 72 hrs; max possible score of 3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: unrinsed; max possible score of 4
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: unrinsed; max possible score of 4
Irritation parameter:
iris score
Remarks:
lesion
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: unrinsed; max possible score of 2
Other effects:
Premium unleaded gasoline (F-64-01) was also instilled into the eyes of 6 rabbits, which were rinsed 20-30 seconds after dosing. This method is not in compliance with OECD TG 405 and is not appropriate for classification purposes. The overall irritation score was 0 (max score out of 110 possible). The mean (24, 48, and 72 hr average) conjunctivae redness, chemosis, corneal opacity, and iris lesion scores were 0, 0, 0, and 0, respectively.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores were 0, 0, 0.06, and 0, respectively. These findings do not warrant classification of premium unleaded gasoline (F-64-01) as an ocular irritant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. 
Executive summary:

Premium unleaded gasoline (F-64-01) was administered to one eye of six New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours and 4 days after treatment. Ocular damage was assessed and scored according to the Draize eye test. Ocular irritation was most prominent at the 48 and 72 hour observation period receiving a Draize score of 0.3. Irritation subsided and all animals were clear of ocular irritation within 4 days after treatment. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores were 0, 0, 0.06, and 0, respectively. These findings do not warrant classification of premium unleaded gasoline (F-64-01) as an ocular irritant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.