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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Indigo has no irritating potential to skin or mucous membranes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP study; Comparable to guideline study; limited information on test itemand its formulation and animal husbandry. Test are in concordance with those recommended by the ETAD. The study results are considered valid for indigo.
Qualifier:
equivalent or similar to guideline
Guideline:
other: FDA Federal Register 38, No 187
Principles of method if other than guideline:
Patch test technique on abraded and intact skin
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
single housed
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg pasted with water
Duration of treatment / exposure:
24 hours
Observation period:
immediately after removal (24 hours after application) and 48 hours after removal (72 hours after application)
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- Coverage: - shaved and scarified skin: 2.5x2.5 cm
- shaved skin: 2.5x2.5 cm
- Type of wrap if used: rubber sheeting


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours with cotton wool and warm water


SCORING SYSTEM: FDA Federal Register 38, No 187

Erythema and eschar formation (EEF) :
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema formation (EF):
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exp.) 4

Calculation of Primary Irritation Indey for intact and abraded skin.
Mean value of 6 animals

Primary Irritation Index (PII) = Animal 1 (EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved) + .... + Animal 6 (EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved)/ 24

EVALUATION:

0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
8
Irritant / corrosive response data:
not irritant
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
The application of Indigo N Lumps to intact and abraded skin for 24 hours did not lead to any signs of skin irritation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited data on test substance
Qualifier:
according to guideline
Guideline:
other: FDA Federal Register 38, No 187
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
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

Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
2.9
Max. score:
110
Remarks on result:
other: Initial pain reaction: 2
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Indigo N Lumps should not cause significant eye irritation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

No adverse effects indicative for respiratory irritation were noted in acute inhalation studies in rats.

Justification for classification or non-classification

No irritating effects observed.