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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:
07 Mar 1955 - 22 Apr 1955
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1955
Report date:
1956

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2017
Deviations:
yes
Remarks:
Immediate eye washing, 2 animals tested, observation after 48 h is missing
Principles of method if other than guideline:
Principle of the test:
50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals (2 animals concentrated test substance, 2 other animals 20% solution and a third group of 2 animals with 20% solution pH 7.5).The eyes were washed out immediately after the application.The animals were observed after 10 min, 1 h and 3 h on the day of treatment and up to 2 weeks afterwards.
GLP compliance:
no
Remarks:
predating GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
water
Controls:
other: the adjacent eye served as control treated with 0.9 % NaCl (saline).
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): concentrated, 20%; 20% pH 7.5

Duration of treatment / exposure:
single application and immediate washing
Observation period (in vivo):
up to 2 weeks (undiluted); up to 4 weeks (20% dilution)
Number of animals or in vitro replicates:
2 per dose
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: immediately

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Undiluted substance, 48 h reading is missing.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.3
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Undiluted substance, 48 h reading is missing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Undiluted substance, 48 h reading is missing
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Undiluted substance, 48 h reading is missing.

Any other information on results incl. tables

Table 1. Findings animal 1/2 (undiluted test substance)

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

-/-

-/- -/- -/-                  
72 h 2/2 0/2 3/3 2/2                  
 8 d 2/x 0/x 3/x 0/x                  
 Mean: 24h - 48h - 72h 2/2 0.3 3/3 2/2                  

-/-: 48 h reading is missing.

x: the animal died on day 7.

The original BASF grading was converted into the numerical grading according to the OECD Draize system

The application of the test substance caused corrosion to the exposed eyes predominantly expressed by severe erythema, chemosis and misty-like corneal opacity with bloody discharge. In one animal occured severe iritis after 72 h. Severe corneal opacity is considered to be an irreversible effect to ophthalmic tissue.

The application of a 20% solution of the test substance caused similar effects then the undiluted test substance (erythema, chemosis and misty-like corneal opacity with bloody discharge). Irreversible corneal opacity.

The application of a neutralized 20% solution of the test substance caused only slight erythema and chemosis on the day of exposure.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test substance caused severe damage to rabbit eye under the tested conditions.
The application of the undiluted test substance caused corrosion to the exposed eyes predominantly expressed by severe erythema, chemosis and misty-like corneal opacity with bloody discharge. In one animal occured severe iritis after 72 h.
Executive summary:

In this eye irritation study, 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals (2 animals concentrated test substance, 2 other animals 20% solution and a third group of 2 animals with 20% solution pH 7.5). The eyes were washed out immediately after the application.The animals were observed after 10 min, 1 h and 3 h on the day of treatment and up to 2 weeks afterwards (longer observation period after dilution application). The treatment of the undiluted test substance caused corrosion to the exposed eyes predominantly expressed by severe erythema, chemosis and misty-like corneal opacity with bloody discharge. In one animal occured severe iritis after 72 h. The application of a 20% solution of the test substance caused similar effects then the undiluted test substance (erythema, chemosis and misty-like corneal opacity with bloody discharge). Cornea opacity was observed until the end of the observation period (up to 4 weeks). The application of a neutralized 20% solution of the test substance caused only slight erythema and chemosis on the day of exposure.