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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:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study equivalent to OECD guideline 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1-propoxypropan-2-ol
EC Number:
216-372-4
EC Name:
1-propoxypropan-2-ol
Cas Number:
1569-01-3
Molecular formula:
C6H14O2
IUPAC Name:
1-propoxypropan-2-ol
Details on test material:
Name of test material (as cited in study report): PROPASOL Solvent P
- Physical state: clear, non-viscous liquid
- Lot/batch No.: #3251; S-066890

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml, 0.01 ml and 0.005 ml
- Concentration (if solution): pure substance (100%)

Duration of treatment / exposure:
single application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
18 (3 males & 3 females per dose level)
Details on study design:
SCORING SYSTEM: the eyes were scored by the system below at one hour, 4 hours, 1 day, 2 days, 3 days, 7 days, 14 days and 21 days.

TOOL USED TO ASSESS SCORE: fluorescein (to determine corneal injury)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0.9
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 5 out of 6 animals had an average score of 1
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0.9
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0.8
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
0.1 ml: minor diffuse corneal injury (opacity), iritis and moderate to severe conjunctival irritation in 6/6 animals; after 7 days: 5/6 appeared normal, 1/6 with persistent corneal vascularization
Microscopically, 6.6 exhibited minimal conjunctival injury characterized by edema, inflammation and perivascular lymphoid infiltrates. These lesions were associated with the corneal limbus. 1/6 had vacuolation of the corneal epithelium.

0.01 ml: diffuse corneal opacity, iritis and moderate conjunctival irritation in 6/6 animals; complete healing with 3 days in 1/6, within 7days in 6/6
Microscopically, 2/6 had mild to moderate conjunctival edema and inflammation in the limbus region. 4/6 had no remarkable histologic lesions.

0.005 ml: minor diffuse corneal injury, iritis and minor to moderate conjunctival irritation in 6/6 animals; complete healing within 3 days in 1/6 and within 7 days in 6/6
Microscopically, 0/6 exhibited significant lesions.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
PROPASOL Solvent P may cause moderate eye irritation and should be classified as eye irritant category 2 according to EU CLP criteria.
Executive summary:

Eighteen New Zealand White rabbits (9/sex) were divided into three groups and were exposed to a single dose of 0.005 ml, 0.01 ml, and 0.01 ml of PROPASOL Solvent P inserted into the conjunctival sac (0.1 ml dose) or applied directly to the cornea (0.01 ml and 0.005 ml) of one of their eyes. The eyelids were held together for one second. Six eyes were dosed per test volume. The animals in the low and intermediate exposure groups were held for observation for one week and then sacrificed. The animals in the high dose exposure group were held for three weeks before sacrifice. The eyes were scored by the system described above at one hour, 4 hours, one day, 2 days, 3 days, 7 days, 14 days and 21 days after dosing. Fluorescein staining was used to determine corneal injury before dosing and at readings after one day. The eyes were collected from all rabbits after euthanasia for pathologic evaluation.

Instillation of 0.1 ml PROPASOL Solvent P into rabbit eyes resulted in minor diffuse corneal injury (opacity) in 6 of 6 animals. Iritis was apparent in 6 animals and moderate to severe conjunctival irritation developed in all 6 animals. After 7 days, 5 rabbits exhibited a normal appearance, but one animal developed corneal vascularization which persisted through 21 days.

After instillation of 0.01 ml, 6 of 6 animals developed minir diffuse corneal opacity. There was iritis in 6 rabbits. Moderate conjunctival irritation appeared in all 6 animals. There was complete healing in one animal within 3 days. Irritation subsided in the other 5 animals by 7 days.

A volume of 0.005 ml produced minor diffuse corneal injury, iritis and minor to moderate conjunctival irritation in 6 rabbits. One animal was healed at 3 days and all appeared normal after 7 days.

Microscopically, eyes dosed with 0.1 ml exhibited minimal conjunctival injury characterized by edema, inflammation abd perivascular lymphoid infiltreates. These lesions were associated with the corneal limbus. One eye had vacuolation of the corneal epithelium. Two middle dose (0.01 ml) eyes had mild to moderate conjunctival edema and inflammation in the limbus region. Four eyes had no remarkable histologic lesions after the 0.01 ml dose. None of 6 eyes receiving 0.005 ml of PROPASOL Solvent P exhibited significant microscopic lesions.