Registration Dossier

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:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Two drops of undiluted test material was applied to the eyes of a rabbit. One eye was washed within 30 seconds of administration and the other was unwashed. Obsevations were made immediately, 1, 24 and 48 hours, and 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test matrial: Ethylene glycol n-propylether
Source: Ethylene Research Laboratory, The Dow Chemical Company

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
2 drops/eye
Duration of treatment / exposure:
Two drops of material was placed in the right eye . The eye was washed (within 30 seconds) for 2 minutes in a flowing stream of tepid water. The left eye was treated with 2 drops of test material, but the eye was left unwashed.
Observation period (in vivo):
Immediately, 1, 24, and 48 hours and 7 days.
Number of animals or in vitro replicates:
1
Details on study design:
Two drops of undiluted test material was applied to the eyes of a rabbit. One eye was washed within 30 seconds of administration and the other was unwashed. Obsevations were made immediately, 1, 24 and 48 hours, and 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: immediate
Score:
3
Max. score:
6
Remarks on result:
other: Unwashed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unwashed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 hours
Score:
3
Max. score:
6
Remarks on result:
other: Unwashed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48 hours
Score:
3
Max. score:
6
Remarks on result:
other: Unwashed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 7 days
Score:
3
Max. score:
6
Remarks on result:
other: Unwashed eye
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: immediate
Score:
1
Max. score:
6
Remarks on result:
other: Unwashed eye
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unwashed eye after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 hour
Score:
4
Max. score:
6
Remarks on result:
other: Unwashed eye after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 hours
Score:
3
Max. score:
6
Remarks on result:
other: Unwashed eye after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 7 days
Score:
3
Max. score:
6
Remarks on result:
other: Unwashed eye after stain
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: immediate
Score:
3
Max. score:
6
Remarks on result:
other: Washed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Washed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 hour
Score:
3
Max. score:
6
Remarks on result:
other: Washed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48 hour
Score:
3
Max. score:
6
Remarks on result:
other: Washed eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 7 days
Score:
3
Max. score:
6
Remarks on result:
other: Washed eye
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: immediate
Score:
2
Max. score:
6
Remarks on result:
other: Washed eye
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Washed eye, after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 hour
Score:
3
Max. score:
6
Remarks on result:
other: Washed eye, after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 hour
Score:
3
Max. score:
6
Remarks on result:
other: Washed eye, after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 7 days
Score:
3
Max. score:
6
Remarks on result:
other: Washed eye, after stain
Irritant / corrosive response data:
Unwashed eye- Moderate conjunctival swelling, corneal damage, slight iritis not subsided in 1 week.

Washed eye- Moderate conjunctival swelling, corneal damage not as severe as unwashed eye, slight iritis not subsided in 1 week
Other effects:
Internal effects in washed and unwashed eye ranged from a score of 1-3 out of a maximum score of 6, reflecting no response to slight, just perceptible.

Pain was slight in unwashed eyes and very slight in washed eyes when evaluated immediately upon administration.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Effects not completely reversed after 7 days. Criteria used for interpretation of results: other: EU GHS
Conclusions:
Moderate effects in the eye not completely reversed after 7 days. According to the EU CLP regulations (GHS Criteria), the substance would be classified as a Category 2A.
Executive summary:

Two drops of undiluted test material was applied to the eyes of a rabbit. One eye was washed within 30 seconds of administration and the other was unwashed. Obsevations were made immediately, 1, 24 and 48 hours, and 7 days. In the unwashed eye, moderate conjunctival swelling, corneal damage, slight iritis were observed and did not subside in 1 week. In the washed eye, moderate conjunctival swelling, corneal damage not as severe as unwashed eye, slight iritis were observed and did not subsided in 1 week. Internal effects in washed and unwashed eye ranged from a score of 1-3 out of a maximum score of 6, reflecting no response to slight, just perceptible. According to the EU CLP regulations (GHS Criteria), the substance would be classified as a Category II.