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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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

Constituent 1
Reference substance name:
Indigo
IUPAC Name:
Indigo

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.