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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
29-Mar to 26-Apr-1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD 404 and GLP compliant. The test substance is leucoindigo in NaOH solution forming the mono- or disodium salt

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Indigolösung BASF 20%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Gaukler; Offenbach
- Age at study initiation: young adult
- Weight at study initiation: 2.4 to 3.3 kg
- Housing: single
- Diet: Kliba Labordiaet 341 ca 130 g/rabbit/day
- Water: tap water ca. 250 mL/rabbit/day
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 30 to 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: 29-Mar to 26-Apr-1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
3 minutes and 1 hour
Observation period:
72 hours
Readings at 1, 24, 48, 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of back or flanks
- Coverage: 2.5 x 2.5 cm
- Type of wrap if used: semiocclusive (Fixomull stretch)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol:water 1:1
- Time after start of exposure: 3 minutes or 1 hour


SCORING SYSTEM: according to Draize
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema 4

Edema formation
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 exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
3 minutes exposure
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
3 minutes exposure
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
1 hour exposure
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
1.6
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: study was terminated at 72 hours due to skin necrosis
Irritant / corrosive response data:
visual necroses were observed in all animals 24 or 72 hours after application
Macroscopic examination of necrotic areas revealed superficial focal necrosis in one and full thickness necrosis in two rabbits.
Other effects:
bluish discoloration of application site

Any other information on results incl. tables

3 Minutes Exposure

 

 Animal

 Erythema

 Edema

 Comments

 1 hour

 01

 NA

 0

index for erythema could not be read because of bluish staining by the test substance

 

 02

 1

 0

skin stained by test substance

 

 03

 1

 0

skin stained by test substance

 24 hours

 01

 2

 0 

skin stained by test substance

 

 02

 2

 1

skin stained by test substance

 

 03

 2

 1

skin stained by test substance

 48 hours

 01

 1

 0

skin stained by test substance

 

 02

 2

 0

skin stained by test substance

 

 03

 2

 0

skin stained by test substance

 72 hours

 01

 1

 0

skin stained by test substance

 

 02

 1

 0

scaling, skin stained by test substance

 

 03

 2

 0

scaling, skin stained by test substance

 Mean

 01

 1.3

 0.0

 

 

 02

 1.7

 0.3

 

 

 03

 2.0

 0.3

 

 Mean

 

 1.7

 0.2

 

 

1 Hour Exposure

 

 Animal

 Erythema

 Edema

 Comments

 1 hour

 01

 NA

 0

index for erythema could not be read because of bluish staining by the test substance

 

 02

 2

 1

hemorrhage,skin stained by test substance

 

 03

 2

 1

hemorrhage,skin stained by test substance

 24 hours

 01

 3

 2

hemorrhage,skin stained by test substance

 

 02

 NA

 2

necrosis, skin stained by test substance

 

 03

 NA

 1

necrosis, skin stained by test substance

 48 hours

 01

 3

 2

superficial scabbing, skin stained by test substance

 

 02

 NA

 2

necrosis, skin stained by test substance

 

 03

 NA

 1

necrosis, skin stained by test substance

 72 hours

 01

 2

 2

superficial focal necrosis, skin stained by test substance

 

 02

 NA

 1

full thickness necrosis, skin stained by test substance

 

 03

 NA

 1

full thickness necrosis, skin stained by test substance

 Mean

 01

 2.7

 2.0

 

 

 02

 NA

 1.7

 

 

 03

 NA

 1.0

 

 Mean

 

 NA

 1.6

 

For calculation of the means of erythema and edema only the readings of 24, 48 and 72 hours were used

 

The study was discontinued after the 72-hour reading because of severe irritation

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions chosen and considering the findings described, Indigolösung BASF 20% gives indication of severe skin damage after an exposure period of 1 hour. As Indigo itself has proven not to be an irritant, this effect is most likely due to the NaOH content of the preparation.