Registration Dossier
Registration Dossier
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EC number: 261-448-2 | CAS number: 58798-47-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 12. to 19. Sep 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, the tested substance is the methyl sulfate salt of the registered substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- EC Number:
- 258-946-7
- EC Name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- Cas Number:
- 54060-92-3
- Molecular formula:
- C20H24N3O.CH3O4S C21H27N3O5S
- IUPAC Name:
- 2-{[2-(4-methoxyphenyl)-2-methylhydrazin-1-ylidene]methyl}-1,3,3-trimethyl-3H-indol-1-ium methyl sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Astrazon Goldgelb GLN trocken
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: -
- Weight at study initiation: 2.8 to 3.3 kg
- Housing: single
- Diet: "Ssniff K 4" (Ssniff Spezialdiaten GmbH, Soest), approx 100-120 g per animal and day feeding once per day in the morning
- Water: tap water was available for ad libitum consultion (between 7 and 19 hrs from automatic watering apparatus)
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): ca. 50 %
- Air changes (per hr): ca 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12. to 19. Sep 1989
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6*6 cm
- % coverage: -
- Type of wrap if used: hypoallepgenic Hansamed® - patch (Beiersdorf no. 2342 PV3) covered with semiocclusive dressing (Fixomull® - Stretch Klebevlies, Beiersdorf no. 2293)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Draize (see attachment)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- no irritating effects
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the test substance can be regarded as 'not irritating to the skin'.
- Executive summary:
A study for irritant potential on the rabbit's skin was conducted with 'ASTRAZON Goldgelb GLN, trocken' in
accordance with the OECD Guideline for Testing of Chemicals No. 404. With respect to the OECD Interpretation
Guides results were interpreted in conjunction with the nature, intensity, and reversibility of the responses observed.
Based on the results the test substance can be regarded as 'not irritating to the skin'.
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