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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:
1980/81
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
BASF-Test method
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
EC Number:
207-586-9
EC Name:
2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
Cas Number:
482-89-3
Molecular formula:
C16H10N2O2
IUPAC Name:
2,2'-biindole-3,3'(1H,1'H)-dione
Constituent 2
Reference substance name:
2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one
IUPAC Name:
2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one
Details on test material:
- Name of test material (as cited in study report): 1) Indigo Teig 20%, alkalisch mit 6% Natronlauge (80/189)
2) Indigo Teig 20%, alkalisch mit 5% Natronlauge (80/190)
3) Indigo Teig 20%, alkalisch mit 4% Natronlauge (80/191)
4) Indigo Teig 20%, alkalisch mit 3% Natronlauge (80/192)
- Molecular formula (if other than submission substance): C16H10N2O2
- Molecular weight (if other than submission substance): 262.3 g/mol
- Smiles notation (if other than submission substance): O=C3c4ccccc4NC3=C2Nc1ccccc1C2=O
- InChl (if other than submission substance): InChI=1/C16H10N2O2/c19-15-9-5-1-3-7-11(9)17-13(15)14-16(20)10-6-2-4-8-12(10)18-14/h1-8,17-18H
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: preparation

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER, 6050 Offenbach
- Age at study initiation: young adult
- Weight at study initiation: 3.6 to 3.8 kg
- Housing: single
- Diet: Ssniff K, Standarddiät für Kaninchen und Meerschweinchen, INTERMAST GMBH, Soest, ad libitum
- Water: tap ad libitum
- Acclimation period: -

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
3 minutes + 1 hour
Observation period:
8 days

Readings:
- 30-60 minutes after removal of patch
- 24 hours, 48 hours, and 8 days after TS application
Number of animals:
no data
Details on study design:
TEST SITE
- Area of exposure: back all 4 test items in parallel on both sides
- Coverage: 2.5 x 2.5 cm
- Type of wrap if used: inert sheet


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


SCORING SYSTEM:
SCORING SYSTEM:
Erythema
1 - questionable
2 - mild
3 - moderate
4 - marked

Edema
1 - minimal
2 - mild
3 - moderate
4 - marked

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
80/189, 80/190, 80/191
Basis:
mean
Remarks:
animals #1 and #2
Time point:
other: 1 hour, 24 hours, 48 hours, 8 days
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: 1 hour treatment
Irritation parameter:
erythema score
Remarks:
80/192
Basis:
mean
Remarks:
animals #1 and #2
Time point:
other: 1 hour, 24 hours, 48 hours, 8 days
Score:
2.5 - 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: 1 hour treatment
Irritation parameter:
edema score
Remarks:
80/189, 80/190, 80/191, 80/192
Basis:
mean
Remarks:
animals #1 and #2
Time point:
other: 1 hour, 24 hours, 48 hours, 8 days
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: 1 hour treatment
Irritation parameter:
erythema score
Remarks:
80/189
Basis:
mean
Remarks:
animals #3 and #4
Time point:
other: 3 minutes, 24 hours, 48 hours, 8 days
Score:
1 - 2
Max. score:
4
Reversibility:
other: one rabbit fully reversible, one rabbit not reversible
Remarks on result:
other: 3 minutes treatment
Irritation parameter:
edema score
Remarks:
80/189, 80/190
Basis:
mean
Remarks:
animals #3 and #4
Time point:
other: 3 minutes, 24 hours, 48 hours, 8 days
Score:
0 - 1.5
Max. score:
4
Reversibility:
fully reversible
Remarks:
8 days
Remarks on result:
other: 3 minutes treatment
Irritation parameter:
erythema score
Remarks:
80/190
Basis:
mean
Remarks:
animals #3 and #4
Time point:
other: 3 minutes, 24 hours, 48 hours, 8 days
Score:
0.5 - 2
Max. score:
4
Reversibility:
other: one rabbit fully reversible, one rabbit not fully reversible
Remarks on result:
other: 3 minutes treatment
Irritation parameter:
erythema score
Remarks:
80/191
Basis:
mean
Remarks:
animals #3 and #4
Time point:
other: 3 minutes, 24 hours, 48 hours, 8 days
Score:
0.5 - 1.5
Max. score:
4
Reversibility:
other: one rabbit fully reversible, one rabbit not fully reversible
Remarks on result:
other: 3 minutes treatment
Irritation parameter:
edema score
Remarks:
80/191
Basis:
mean
Remarks:
animals #3 and #4
Time point:
other: 3 minutes, 24 hours, 48 hours, 8 days
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 3 minutes treatment
Irritation parameter:
erythema score
Remarks:
80/192
Basis:
mean
Remarks:
animals #3 and #4
Time point:
other: 3 minutes, 24 hours, 48 hours, 8 days
Score:
0 - 0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 3 minutes treatment
Irritation parameter:
edema score
Remarks:
80/192
Basis:
mean
Remarks:
animals #3 and #4
Time point:
other: 3 minutes, 24 hours, 48 hours, 8 days
Score:
0
Max. score:
4
Remarks on result:
other: 3 minutes treatment
Irritant / corrosive response data:
1 hour exposure:
- no difference between preparations
- necrosis and edema up to the end of the observation period

3 minutes exposure:
- skin reactions clearly dependent on NaOH concentration

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The application of Indigo rein BASF Teig 20% containing 3%, 4%, 5%, or 6% NaOH for 1 hour resulted in necrotic changes and edema up to the end of the 8-day observation period. As Indigo itself proved not to be a skin irritant, this effect is due to the NaOH content of the preparation.