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Registration Dossier
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EC number: 212-974-6 | CAS number: 894-86-0
Specific investigations: other studies
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:
- 1 987
- 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 substance name:
- Indigo
- IUPAC Name:
- Indigo
Constituent 1
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.
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