Registration Dossier
Registration Dossier
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EC number: 201-906-0 | CAS number: 89-41-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990 - 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-nitro-p-anisic acid
- EC Number:
- 201-906-0
- EC Name:
- 3-nitro-p-anisic acid
- Cas Number:
- 89-41-8
- Molecular formula:
- C8H7NO5
- IUPAC Name:
- 4-methoxy-3-nitrobenzoic acid
- Details on test material:
- purity: 98.2%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionial breeding
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 3.5 - 4.5 kg
- Housing: in air conditioned rooms in single cages
- Diet: Altromin 2123 - rabbit ( ad libitum) and 15 g hay per day
- Water: deionized and chlorinated water from automatic suspensors ( ad libitum)
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 500 mg suspended in 0.4 ml 0.9% NaCl-solution
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100%
- Type of wrap if used:plaster fixed with a semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with slightly warm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- no signs for irritation occured
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not skin irritating
- Executive summary:
The substance was tested for skin irritation according to OECD 404. 3 male New Zealand White rabbits got applicated 500 mg of the test substance suspended in 0.4 ml 0.9% NaCl-solution.The exposure time was 4 hours. After removing the plaster and washing the contaminated skin no sign for skin irritation could be observed
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