Registration Dossier
Registration Dossier
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EC number: 212-974-6 | CAS number: 894-86-0
Toxicological information
Skin irritation / corrosion
Currently viewing:
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:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- BASF-Test method
- GLP compliance:
- no
Test material
- 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
- 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
Constituent 1
Constituent 2
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.
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