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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non-GLP guideline study, however with some deviations. The lower end of the housing temperature range (16-18°C) was outside of the range (20°C +/- 3°C) specified in OECD Guideline 405; the observation period was 8 days whereas the guideline recommends 21 days to clarify reversibility; no data on the purity of the test item given.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
secondary source
Title:
O-Phenylphenol and its Sodium and Potassium Salts: A Toxicological Assessment
Author:
Bomhard, E. M. et al.
Year:
2002
Bibliographic source:
Crit. Rev. Toxicol. 32(6):551-626

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
the lower end housing temperature range (16-18 °C) was outside the range specified in the guideline, observation time was 8 days instead of 21, no data on test material purity
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Preventol O extra
- No further details provided in the study report

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH& Co. KG, Extertal, Germany
- Weight at study initiation: 2.7 kg
- Housing: in single cages
- Diet: "muemmel z" (ssniff/Soest), ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye remained untreated and served for control
Amount / concentration applied:
0.1 mL bulk volume instilled into the conjunctival sac of the lower eyelid of the right eye of each animal.
Duration of treatment / exposure:
single administration without washing
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 male animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM:
- Reading time points: 1 h, 24 h, 48 h, 72 h, day 8
- Scoring: Draize Scoring System

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
1.66
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: corneal opacity graded 2 still was evident at day 8
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
1.66
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: corneal opacity graded 3 still was evident at day 8
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: corneal opacity graded 2 still was evident at day 8
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
1.33
Max. score:
2
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: iritis graded 2 still was evident at day 8
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
0.66
Max. score:
2
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: iritis graded 2 still was evident at day 8
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
0.66
Max. score:
2
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: iritis graded 2 still was evident at day 8
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
1.66
Max. score:
3
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: redness of the conjunctivae graded 1 still was evident at day 8
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: redness of the conjunctivae graded 1 still was evident at day 8
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
1.33
Max. score:
3
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: redness of the conjunctivae graded 1 still was evident at day 8
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
2.33
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: chemosis graded 1 still was evident at day 8
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
2.33
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: chemosis graded 1 still was evident at day 8
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: chemosis graded 1 still was evident at day 8
Irritation parameter:
other: discharge
Basis:
animal #1
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: eye discharge with moistening of the eyelids and hair (grade 2) was noticed at 24 and 48 h
Irritation parameter:
other: discharge
Basis:
animal #2
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: eye discharge with moistening of the eyelids and hair (grade 2) was noticed at 1, 24 and 48 h; discharge was slighter at 72 h and no more evident after 8 days.
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
mean over the 3 following time points
Time point:
other: 24+48+72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: eye discharge with moistening of the eyelids and hair (grade 1 to 2) was noticed at 1, 24, 48 and 72 h; discharge was no more evident after 8 days.
Irritant / corrosive response data:
The single instillation of the test item in the eye of rabbit resulted in ocular irritation.
At reading time point 1 hour, corneal opacity of grade 1 to 2, conjunctival redness (grade 1) and chemosis (grade 1 to 2) were observed in all 3 animals; in two of them, discharge above normal also was reported (grade 1 to 2).
At reading time point 24 hour, corneal opacity of grade 1 to 2, conjunctival redness (grade 1 to 2) and chemosis (grade 2 to 3) were observed in all 3 animals; they all further showed discharge above normal (graded 2).
At reading time point 48 hour, corneal opacity of grade 2, conjunctival redness (grade 1 to 2) and chemosis (grade 2) were observed in all 3 animals, which all still showed discharge above normal (graded 2); in addition signs of iritis were noticed in all animals and were graded 1 to 2.
At reading time point 72 hour, corneal opacity of grade 2, conjunctival redness (grade 2) and chemosis (grade 2) were observed in all 3 animals; discharge still remained above normal in 2 cases (grade 2) whereas for the third animal, discharge had turned back to normal; signs of iritis still were evident in all animals (grade 1 to 2).
After 8 days, corneal opacity of grade 2 to 3, conjunctival redness (grade 1), chemosis (grade 1), and iritis (grade 2) still were evident in all 3 animals, indicating that the findings were not reversible within 8 days following treatment. No more discharge above normal was seen.


Other effects:
none

Any other information on results incl. tables

Tab. 1: Results of the eye irritation study with Preventol o extra

Reading time point

1 h

24 h

48 h

72 h

8 days

Animal No.

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

Cornea score

1

1

2

1

1

2

2

2

2

2

2

2

2

3

2

Iris score

0

0

0

0

0

0

2

1

1

2

1

1

2

2

2

Conjunctivae score

1

1

1

1

2

1

2

2

1

2

2

2

1

1

1

Chemosis score

1

2

2

3

3

2

2

2

2

2

2

2

1

1

1

Discharge

0

2

1

2

2

2

2

2

2

0

1

2

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye damage 1, H318
DSD: Xi, R41