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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:
1994-12-06 - 1995-04-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically valid GLP study on the registered substance itself according to US EPA guideline 81-4.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction Products of Diphosphorus Pentaoxide with n-Alcohols, C8-10 (even), salted with Amines, C12-14, Tert-alkyl
EC Number:
943-016-1
Molecular formula:
Too complex
IUPAC Name:
Reaction Products of Diphosphorus Pentaoxide with n-Alcohols, C8-10 (even), salted with Amines, C12-14, Tert-alkyl
Test material form:
other: liquid
Details on test material:
- Substance type: pure substance
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approx. 2.0 - 3.5 kg
- Housing: The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322 was provided ad libitum to the animals throughout the study.
- Water (e.g. ad libitum): Municipal tap water treated by reverse osmosis was available to the animals ad libitum throughout the study.
- Acclimation period: Min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-70°F (18.3-21.1°C)
- Humidity (%): 21-69%
- Air changes (per hr): 10-12 / h
- Photoperiod (hrs dark / hrs light): 12h / 12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contralateral eye of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Duration of treatment / exposure:
single instillation, no wash-out
Observation period (in vivo):
at least 14 days
Number of animals or in vitro replicates:
6 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
wash-out after 24h during examination with fluorescein

SCORING SYSTEM:
Ocular Grading System based on Draize method, See table 1

TOOL USED TO ASSESS SCORE: auxiliary light source, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: ocular tissue irritation
Remarks on result:
other: severe irritant, see "Any other information on results incl. tables"
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h
Score:
36.67
Max. score:
39
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h
Score:
55
Max. score:
61
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
39.33
Max. score:
55
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
31.5
Max. score:
55
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 days
Score:
20.83
Max. score:
55
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
12.17
Max. score:
46
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 10 days
Score:
7.83
Max. score:
34
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 14 days
Score:
2
Max. score:
12
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 21 days
Score:
1.67
Max. score:
10
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Irritation parameter:
cornea opacity score
Remarks:
corneal opacity
Basis:
mean
Score:
2
Reversibility:
fully reversible within: 21 days in 5/6 eyes
Remarks on result:
other: irritant, see "Any other information on results incl. tables"
Irritation parameter:
iris score
Remarks:
iris lesions
Basis:
mean
Score:
0.5
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: nonirritant, see "Any other information on results incl. tables"
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
mean
Score:
2.11
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: nonirritant, see "Any other information on results incl. tables"
Irritation parameter:
chemosis score
Remarks:
conjunctival edema
Basis:
mean
Score:
1.22
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: nonirritant, see "Any other information on results incl. tables"
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Exposure to the test article produced corneal opacity in 6/6 test eyes at the 1 hour scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The corneal opacity resolved completely in 5/6 test eyes by study day 21. Iritis was noted in 6/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in all animals by study day 7. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by study day 21. Additional ocular findings included sloughing, corneal neovascularization and raised area on the cornea, which were noted in 4/6, 2/6 and 1/6 test eyes, respectively.
A normal background finding of superficial stippling was observed in 1 /6 test eyes during the fluorescein examination. This finding was transient and was not considered significant. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.
See "Any other information on results incl. tables" for further information.

Any other information on results incl. tables

See Attachment.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study is well-documented and was performed according to EPA OPP 81-4 (Acute Eye Irritation), under GLP conditions. Hence, the information provided in the report can be considered reliable. In consequence, the results are suitable for the assessment of the acute dermal irritation potential of the test item. According to the Ocular Evaluation Criteria, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. According to the EEC Ocular Evaluation Criteria, the test item is considered to be an irritant for corneal opacity, a nonirritant for iris lesion, a nonirritant for conjunctival redness and a nonirritant for conjunctival edema.
Executive summary:

In a primary eye irritation study (EPA OPP 81-4), young adult New Zealand White rabbits (6 females) were exposed to 0.1 ml of the undiluted test item via single instillation into the conjunctival sac with wash-out after 24h during examination with fluorescein. Animals then were observed for 21 days.

Exposure to the test article produced corneal opacity in 6/6 test eyes at the 1 hour scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The corneal opacity resolved completely in 5/6 test eyes by study day 21. Iritis was noted in 6/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in all animals by study day 7. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by study day 21. Additional ocular findings included sloughing, corneal neovascularization and raised area on the cornea, which were noted in 4/6, 2/6 and 1/6 test eyes, respectively.

A normal background finding of superficial stippling was observed in 1 /6 test eyes during the fluorescein examination. This finding was transient and was not considered significant. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

In this study, the undiluted test item is severe irritant to the ocular tissue of the rabbit. According to the EEC Ocular Evaluation Criteria, the test item is considered to be an irritant for corneal opacity, a nonirritant for iris lesion, a nonirritant for conjunctival redness and a nonirritant for conjunctival edema.