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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:
30.08.1988 - 27.09.1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Physical state: greyish-green powder
- Analytical purity: 100%
- Lot/batch No.: 3883559 A
- 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: Hazleton-Dutchland Inc., Denver, Pennsylvania.
- Age at study initiation: young adults (at least 8 weeks old)
- Weight at study initiation: no data
- Housing: individually
- Diet: Lab Rabbit Chow HF (Purina #5326), 125 g/day while on test.
- Water: tap water, ad libitum.
- Acclimation period: 56 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 cm3
Duration of treatment / exposure:
Single application, eyes were not washed after treatment.
Observation period (in vivo):
28 days
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No wash was performed after application of the material. Approximately 24 h after application, the treated eyes were rinsed to remove any residual test application.

SCORING SYSTEM: draize score

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.1
Max. score:
2
Reversibility:
fully reversible within: 28 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.4
Max. score:
4
Reversibility:
not fully reversible within: 28 days

Any other information on results incl. tables

Findings animals 1/2/3/4/5/6 (undiluted test substance):

 Time   Opacity Iritis   Conjunctival  Erythema  Conjunctival Chemosis                  
1 h +/+/+/0/+/+ +/0/+/+/0/+ 2/1/1/1/1/1 0/0/0/0/0/1                  
24 h 2/1/2/2/2/2 1/1/1/1/1/1 3/3/3/3/3/3 3/3/3/3/3/3                  
48 h

2/+/2/1/2/2

2/1/1/1/1/1 3/3/3/2/2/3 3/2/3/2/2/2                  
72 h 2/+/1/+/+/+ 2/1/1/1/+/1 3/2/3/2/2/2 2/2/2/2/2/2                  
 7 d 2/+/1/2/+/1 2/1/1/1/0/+ 2/2/2/2/1/2 1/1/2/1/1/1                  
14 d 2/+/2/1/0/0 2/1/1/0/0/0 2/2/1/2/2/1 2/1/1/1/0/0                  
 28 d  2/+/2/2/0/0  0/0/0/0/0/0 1/1/1/1/0/0  1/0/0/1/0/0                   

The test substance caused serious damage to eyes. All six animals exhibited severe conjunctival irritation (redness, chemosis, discharge, necrosis), corneal opacity, ulceration and iridial damage. All six animals also exhibited pannus (neovascularization of the corneal surface) one or more times between days 7 and 28. On day 7 one animal had an enlarged blood vessel on the anterior surface of the iris. Two animals had a fluid filled blister on the corneal surface on day 21 and/or 28. Three animals were noted to have hair loss around the eye. All six animals continued to exhibit severe irritation at termination of the study (day 28).

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: risk of serious damage to eyes