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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
the test was terminated at post-application day 15, when effects were not completely reversed
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was performed

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Phenoxyethanol (technical grade)
- Analytical purity: no data
- Lot/batch No.: substance number: 83/143
- Expiration date of the lot/batch: May 1984

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; Offenbach, Germany
- Age at study initiation:
- Weight at study initiation: 2.51 kg, 2.37 kg, 2.61 kg
- Housing: single housing in stainless-steel cages
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm, Muskator-Werke Duesseldorf, Germany
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The substance remained in the eye, therefore 15 days.
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to OECD and Draize

Corneal Opacity (maximum possible: 4)
0 = no finding
1 = slight opacity
2 = well-defined opacity
3 = severe opacity
4 = very severe opacity

Involved corneal area
1 = > 0 - < ¼
2 = >= 1/4 - < ½
3 = >= ½ - < ¾
4 = >= 3/4

Iris (maximum possible: 2)
0 = no finding
1 = ciliary injection
2 = iritis

Conjunctival redness (maximum possible: 3)
0 = no finding
1 = slight redness
2 = well-defined redness
3 = severe redness

Conjunctival swelling (maximum possible: 4)
0 = no finding
1 = slight swelling
2 = well-defined swelling
3 = severe swelling
4 = very severe swelling

Secretion (maximum possible: 3)
0 = no finding
1 = slight increase
2 = well-defined increase
3 = severe increase

Calculation of the irritation index:
For each animal and each reading time point, the irritation index (I) was calculated according to following formula:
I = A + B + C
A = 5 x opacity x involved corneal area
B = 5 x iris
C = 2 x (conjunctival redness + swelling + secretion)

The primary irritation index (PI) was the sum of all irritation indices for all animals and all reading time points (24, 48 and 72 h), subdivided by 3 x the number of animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: occurence of effects after 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1.7
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: occurence of effects after 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1.3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24,48 and 72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24,48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 47 and 72 h
Score:
1.3
Reversibility:
fully reversible within: 8 days
Other effects:
Additional symptoms such as narrowness of pupil, scarred retraction of eyelid, marginal corneal vascularisation and suppuration were also considered.
No clinical signs observed.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: eye irritation Cat. 2