Registration Dossier
Registration Dossier
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EC number: 228-782-0 | CAS number: 6358-64-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-03-04 to 1986-03-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP-study according to previous OECD-TG
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP compliance statement attached to full study report.
Test material
- Reference substance name:
- 4-chloro-2,5-dimethoxyaniline
- EC Number:
- 228-782-0
- EC Name:
- 4-chloro-2,5-dimethoxyaniline
- Cas Number:
- 6358-64-1
- Molecular formula:
- C8H10ClNO2
- IUPAC Name:
- 4-chloro-2,5-dimethoxyaniline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Hoechst AG, Kastengrund, conventional breed
- Identification: numbered earmarks
- Weight: 2.1 - 2.5 kg
- Age: approx. 3-5 months
- Housing: in air conditioned rooms, single cages
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hrs daily
- Feed: Altromin 2123 rabbit diet, ad libitum, as well as approx 15 g hay daily
- Water: deionised, chlorinated water from automatic dispenser, ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - 500 mg of test substance moistened with 0.25 mL polyethyleneglycole 400
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60mins and 24, 48, 72 hours after removal of patch
- Number of animals:
- 3
- Details on study design:
- - Area of coverage: 2.5x2.5 cm^2
- After 4 hours removal of patch and washing with luke warm water
- Type of patch: cellulose
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean
- Score:
- 0
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 present study, 4-chloro-2,5-dimethoxyaniline is not classified and labelleded a skin irritant according to 83/467/EEC.
- Executive summary:
In the course of the study no signs of irritation were observed. Based on the results of the present study, 4-chloro-2,5-dimethoxyaniline is not classified and labelleded a skin irritant according to 83/467/EEC.
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