Registration Dossier

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:
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 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:
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.