Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
publication
Title:
Toxicology of Indigo - a review
Author:
Ferber KH
Year:
1987
Bibliographic source:
J. Environ. Pathol. Toxicol. Oncol. 7, 73 -84 (1987)

Materials and methods

Principles of method if other than guideline:
U.S. FDA 1962-1973
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Results and discussion

Details on results:
No-toxic-effect-level (NOAEL = no observed adverse effect level): not estimated


Results:

72 young, albino New Zealand rabbits of each sex were

used in end-use tests as colorant for surgical sutures.

The test substance, D&C Blue No. 6 was incorporated

into plain and chromic collagen eye sutures (size 6-0).

The dyed as well as undyed sutures were implanted into

the cornea, sclera, dorsal nectus muscle and

subconjunctiva of the rabbits of each sex. During a

total period of 180 days several investigations (no

more data) were performed.

The following test substance-related findings were

obtained:


1) Clinical examinations

No data available.


2) Clinical laboratory investigations

No data available.


3) Effect on the organs / Pathology

No data available.


4) No-effect-level (NOEL = no observed effect level):

not estimated

Applicant's summary and conclusion

Conclusions:
The eyes were examined daily for the first ten days and weekly thereafter for a total period of 180 days. A parallel experiment was also conducted using size 6-0 plain and chromic catgut sutures. All animals were sacrificed at termination of the study and the eyes and adjacent tissues examined grossly and microscopically. Evidence of reactions was graded on a scale of 1 to 4.
It was concluded that the use of the test substance D&C Blue No. 6 to color either collagen or catgut sutures does not affect their safe use in opthalmological procedures
Executive summary:

The eyes were examined daily for the first ten days and weekly thereafter for a total period of 180 days. A parallel experiment was also conducted using size 6-0 plain and chromic catgut sutures. All animals were sacrificed at termination of the study and the eyes and adjacent tissues examined grossly and microscopically. Evidence of reactions was graded on a scale of 1 to 4.

It was concluded that the use of the test substance D&C Blue No. 6 to color either collagen or catgut sutures does not affect their safe use in opthalmological procedures.