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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test procedure in accordance with national standard methods with acceptable restrictions, study well documented; significance limited due to substance-induced coloration of the eye, which didn't allow correct reading of all eye reactions; observed eye reactions could be caused by other components of the product (acetic acid).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Method: Draize Test
according to: Federal Register 38, No. 187, §1500.42, p.27019 of Sep 27, 1973
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethylviolett fluessig

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Weight at study initiation: male and female : 2.61 kg (mean)



Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 male /3 female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Reversibility:
not reversible
Remarks on result:
other: No redness or opacity could be detected due to coloration of the conjuctivae and cornea.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Reversibility:
not reversible
Remarks on result:
other: No redness or opacity could be detected due to coloration of the conjuctivae and cornea.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Reversibility:
not reversible
Remarks on result:
other: No redness or opacity could be detected due to coloration of the conjuctivae and cornea.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Opacitiy of the cornea, iritis and redness of the conjunctivae could not be detected due to substance-induced coloration. The individual mean score for conjunctivae swelling was 2.7 in 3 animals and 4.0 in 3 animals, respectively. After 24 and 48h, slightly increased discharge, after 72 h discharge with moistening of the lids and hairs, and considerable area around the eye was observed in all animals. Lymphoma was observed in 4 of 6 rabbits 72 h after the beginning of the study. After 8 days very severe edema, severe suppuration, bloody crusts and lymphoma were observed. Opacitiy of the cornea, iritis and redness of the conjunctivae could not be detected due to substance-induced coloration.

Any other information on results incl. tables

EYE SCORING:

Animal No.

Time

(hrs)

Cornea

Iris

Conjunctivae

Redness

Chemosis

1

 

24

*

*

*

2

48

*

*

*

2

72

*

*

*

4

2

 

24

*

*

*

4

48

*

*

*

4

72

*

*

*

4

3

 

24

*

*

*

2

48

*

*

*

2

72

*

*

*

4

4

 

24

*

*

*

4

48

*

*

*

4

72

*

*

*

4

5

 

24

*

*

*

2

48

*

*

*

2

72

*

*

*

4

6

 

24

*

*

*

4

48

*

*

*

4

72

*

*

*

4

* No redness or opacity could be detected due to coloration of the conjunctivae and cornea.

Applicant's summary and conclusion

Interpretation of results:
other: serious damage to the eyes
Conclusions:
Classification: risk of serious damage to eyes