Registration Dossier
Registration Dossier
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EC number: 265-479-2 | CAS number: 65122-08-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16 section 1500.51
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate
- EC Number:
- 265-479-2
- EC Name:
- 2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate
- Cas Number:
- 65122-08-9
- Molecular formula:
- C25H29N2.C2H3O2
- IUPAC Name:
- 2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: W Ostrop/Meerbusch
- Age at study initiation: no data
- Weight at study initiation: mean 2.6 kg
- Housing: individually (restrained)
- Diet: mümmel z, SNIFF Soest ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 °C
- Humidity (%): 40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- test was done on intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 500 ug
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- at 24 (at removal of the dressing), 48 (not reported) and 72 hours and after 8 days
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: 5x5 cm
- Type of wrap if used: occlusive, chirurgical gaze with PVC cover
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) at 24 (at removal of the dressing), 48 (not reported) and 72 hours and after 8 days
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48 h
- Remarks on result:
- not determinable
- Remarks:
- staining of the skin at 24 and 72 hours and after 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- at 24 and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- at 24 and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- at 24 and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- positive indication of irritation
- Remarks:
- at 24 and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- at 24 and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- at 24 and 72 h
- Irritant / corrosive response data:
- full destruction of the dermis was observed with penetration in the subcutaneous tissue. Therefore the substance is considered corrosive to the skin
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Under the conditions of the test the substance is corrosive to the skin
- Executive summary:
Six male rabbits were treated with the substance under occlusion during 24 hours. Observations at 24 and 72 hours and at 8 days showed full destruction of the skin with penetration in the subcutaneous tissue. The substance is corrosive to the skin.
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