Registration Dossier

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only one animal used
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
1/10 mL
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 rabbit
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No washing

SCORING SYSTEM: According to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritant / corrosive response data:
After 21 days the animals showed deformed eye-ball (ulcus cornea), moderate to severe corneal opacity, strongly vascularized fibroangioblastic tissue on cornea, iris and conjunctivae without visible damage.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. Severe eye damaging effects were observed on one animal.
Executive summary:

The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. An amount of 1/10 mL of the test substance was applied undiluted to the eye of one rabbit. The other eye served as control eye. The eyes are not washed following instillation. The eye are examined at 24, 48, 72 hours, 7 days, 14 days and 21 days after instillation. The following results were determined (mean value 24, 48 and 72 h):

Scores of the animal examined

Cornea: 2 -3

Iris: 1

Conjunctivae: 3

Chemosis: 3

The effects were not reversible after 21 days. The test item showed severe eye damaging effects cat .1.