Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted before the adoption of OECD 405, but similar (no deviations). Batch number and purity not given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Test for Eye irritants, prescribed by The Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500.42
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): XDI (Takenate 500)
- Appearance: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: no data
ENVIRONMENTAL CONDITIONS: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable

VEHICLE: not applicable
Duration of treatment / exposure:
No data
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 albino rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE: no data
SCORING SYSTEM: according to OECD 405
TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: conjunctivae score: redness
Basis:
other: mean for animals #1, #2, #3, #4, #5 and #6
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
2.05
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Individual mean scores: 2-2-2-2-2.3-2
Irritation parameter:
other: conjunctivae score: chemosis
Basis:
other: mean for animals #1, #2, #3, #4, #5 and #6
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
3.78
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Individual mean scores: 3.7-4-3.7-3.7-3.7-4

Any other information on results incl. tables

- Corneal opacities and iritis were observed in all 6 animals

- A diffuse, crimson or beefy-red colouration of the conjunctivae accompanied by considerable swelling with the eye almost completely closed was observed in all 6 animals

- The scored ocular reactions were as follows: 

Animal No.

Ocular lesions

DAY after installation

1

2

3

4

7

1

Cornea

1

3

3

*

**

Iris

*

*

1

*

Conjunctivae

Redness

2

2

2

2

Chemosis

3

4

4

4

2

Cornea

1

2

2

3

Iris

*

0

1

1

Conjunctivae

Redness

2

2

2

2

Chemosis

4

4

4

4

3

Cornea

*

1

2

2

Iris

*

0

0

1

Conjunctivae

Redness

2

2

2

2

Chemosis

4

4

3

3

4

Cornea

*

2

2

2

Iris

*

0

1

1

Conjunctivae

Redness

2

2

2

2

Chemosis

4

4

3

3

5

Cornea

1

*

3

3

Iris

*

*

1

1

Conjunctivae

Redness

2

2

3

3

Chemosis

3

4

4

4

6

Cornea

*

*

3

3

Iris

*

*

1

1

Conjunctivae

Redness

2

2

2

2

Chemosis

4

4

4

4

* Due to the severity of the conjunctival reactions, the scoring could not be assessed

** Due to the severity of the conjunctival reactions, the animals were killed on day 7

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As the effects on conjunctiva were not fully reversible within the observation period of 7 days, the substance is classified as Causing serious damage to eyes (Category 1)
Executive summary:

In a test similar to OECD 405 eye irritation of the test substance was tested in rabbits. Corneal opacity, iritis, and a diffuse, crimson or beefy-red colouration of the conjunctivae accompanied by considerable swelling with the eye almost completely closed were observed in all 6 animals. Animals were killed for humane reasons on day 7. As reversibility could not be observed, the substance should be classified according to Regulation EC 1272/2008 with category 1, H318 "Causes serious eye damage".