Registration Dossier
Registration Dossier
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EC number: 230-086-7 | CAS number: 6940-53-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-02-18 to 1986-02-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP and guideline study.
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP compliance statement attached to full study report.
Test material
- Reference substance name:
- 1-chloro-2,5-dimethoxy-4-nitrobenzene
- EC Number:
- 230-086-7
- EC Name:
- 1-chloro-2,5-dimethoxy-4-nitrobenzene
- Cas Number:
- 6940-53-0
- Molecular formula:
- C8H8ClNO4
- IUPAC Name:
- 1-chloro-2,5-dimethoxy-4-nitrobenzene
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: 2.6 - 3.2 kg
- Age: approx. 3 - 5 months
- Housing: single cages in air conditioned rooms
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hours daily
- Diet: Altromin 2123, ad libitum, hay: approx 15g daily
- Water: deionised, chlorinated water from automatic dispensers, ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethylene glycol 400
- Controls:
- no
- Amount / concentration applied:
- - 500 mg of test substance mixed with 0.3 ml of the vehicle.
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 30-60 mins, 24, 48, 72 hrs
- Number of animals:
- 3
- Details on study design:
- - Area of exposure: 2.5 x 2.5 cm
- Cellulose pad
- Washing with luke warm tap water after 4 hrs of exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- 30-60 mins after removal of the patch one animal showed a clearly distinct erythema. 24 hrs after exposure the same animal only had a barely visible erythema. 48 hrs p.a. none of the animals showed any sign of skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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