Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (OECD 405). Non-GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: according to Fed. Reg. 38 (187), §1500.42, p. 27029, 27-Sep-1973
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
veratrylcyanid
IUPAC Name:
veratrylcyanid
Constituent 2
Reference substance name:
78/834
IUPAC Name:
78/834
Details on test material:
Veratrylcyanid; no data on purity given in the report

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- diet: SSNIFF, Intermast

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (1 female and 5 males).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: animal #1 - #6
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
iris score
Basis:
other: animal #1 -#6
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1.7
Max. score:
3
Reversibility:
other: A full reversibility of the symptoms within 21 days can be expected.
Remarks on result:
other: individual scores: 2 - 2 - 1
Irritation parameter:
chemosis score
Basis:
animal: animal #1 - #6
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
conjunctivae score
Basis:
other: animal #2, #4, #5 and #6
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
3
Reversibility:
other: A full reversibility of the symptoms within 21 days can be expected.
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 0

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

24 h

1

0

0

0

2

0

1

2

0

0

0

1

0

0

3

0

0

0

1

0

0

4

0

0

0

1

0

0

5

0

0

0

1

0

1

6

0

0

0

1

0

0

48 h

1

0

0

0

2

0

1

2

0

0

0

1

0

0

3

0

0

0

1

0

0

4

0

0

0

1

0

0

5

0

0

0

1

0

0

6

0

0

0

1

0

0

72 h

1

0

0

0

1

0

0

2

0

0

0

1

0

0

3

0

0

0

0

0

0

4

0

0

0

1

0

0

5

0

0

0

1

0

0

6

0

0

0

1

0

0

Mean

24-72 h

1-6

0

0

0

1.1

0

0.2

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the test substance vertarylcyanid does not need to be classified according to Regulation (EU) No. 1272/2008 and Directive 67/548/EEC.