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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited data on test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: FDA
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Vat Indigo Sodium Salt
IUPAC Name:
Vat Indigo Sodium Salt
Details on test material:
- Name of test material (as cited in study report): Indigo 60% Grains

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
72 hours
readings at 1, 24, 48, 72 hours after instillation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: -


SCORING SYSTEM:
see Tab. 1 and Tab. 2

Index for Assessment
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
92
Max. score:
110
Remarks on result:
other: Initial Pain reaction: 4

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Indigo 60% Grains may cause severe eye irritation, accompanied by severe initial pain. As Indigo itself proofed not to be irritating this effect is most likely due to the 5% alkali content.