Registration Dossier
Registration Dossier
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EC number: 201-963-1 | CAS number: 90-04-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 OCT 1984 to 27 OCT 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
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:
- o-anisidine
- EC Number:
- 201-963-1
- EC Name:
- o-anisidine
- Cas Number:
- 90-04-0
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 2-methoxyaniline
- Details on test material:
- - Name of test material (as cited in study report): Echtrot BB Base flüssig
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, conventional breed
- Weight at study initiation: 2.5 to 3.1 kg
- Housing: single caged in fully conditioned rooms
- Diet: Altromin 2123 rabbit diet (Altromin GmbH, Lage/lippe, Germany), ad libitum
- Water: deionised, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x2.5 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: done with lukewarm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animal # 1 and 2 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- other: animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: initial, slight effect were fully reversible within 24 h
- Irritant / corrosive response data:
- 30-60 minutes after end of exposure:
- All animals showed well defined erythema (score: 2) as well as very slight edema (score:1)
24 h reading:
- 2/3 animals still show well defined erythema (score:2), one animal shows only very slight erythema (score: 1)
- no more edema seen in any of the animals
48 h reading:
- all animals show very slight erythema (score: 1).
72 h reading:
-the erythema seen before vanished in all animals
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- Based on that findings the test substance is neither skin irritating nor skin corrosing. The test material contains relevant amounts of the submission substance. Therefore the test results are adequat to fulfil the endpoint requirements.
- Executive summary:
Test material "Echtrot BB Base flüssig" was subject to an acute dermal irritation/corrosion test in 3 New Zealand White rabbits according to OECD TG 404. After the 4 h exposure to 0.5 ml of the undiluted test material under semi-occlusive conditions only minor effects were seen in all animals (erythema score: 0 -2; edema score: 0 -1). These effects were fully reversible until the 72 h reading. Based on that findings the test substance is neither skin irritating nor skin corrosing
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