Registration Dossier
Registration Dossier
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EC number: 213-584-9 | CAS number: 989-38-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Refer to section 'Principles of method if other than guideline'
- Principles of method if other than guideline:
- Deviation from OECD guideline 404:
- BASF-method, 20h exposure
- Occlusive type of coverage instead of semi-occlosive.
- Exposure period of 20 h instead of 4 hours.
- Observation period of 8 days instead of 14 days.
The named deviations from the OECD guideline 404 represents a tightening of the test conditions. - GLP compliance:
- no
Test material
- Reference substance name:
- 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride
- EC Number:
- 213-584-9
- EC Name:
- 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride
- Cas Number:
- 989-38-8
- Molecular formula:
- C28H31N2O3.Cl
- IUPAC Name:
- 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.24 and 3.04 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 50% solution - Duration of treatment / exposure:
- 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: Back and ear of the rabbits
- % coverage: Back: 2.5 x 2.5 cm
OBSERVATION TIME POINTS: 24 hours and 8 days
SCORING SYSTEM:
- Method of calculation: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- other: 20 hours
- Remarks on result:
- no indication of irritation
- Remarks:
- red substance residues
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- other: 20 hours
- Remarks on result:
- no indication of irritation
- Remarks:
- red substance residues
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is not considered to cause corrosion or irritation to the skin.
- Executive summary:
An skin irritation potential of the test substance was investigated in an in vivo study performed equivalent to OECD guideline 404. A 50% solution of the test substance in water was applied to the shaved skin of two Vienna White rabbits. The test was performed under occlusive conditions for an exposure period of 20 hours. The skin was scored for signs of irritation after 24 hours and 8 days. Under the conditions of this test no indication of skin irritation was observed.
The performed skin irritation test showed some deviations from the OECD guideline 404. For example the test item was tested under occlusive instead of semi-occlusive conditions. Further, an exposure period of 20 hours instead of 4 hours was applied. The named deviations from the OECD guideline 404 represents a tightening of the test conditions. Based on the results of this test, the test substance is considered not irritating to the skin.
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