Registration Dossier
Registration Dossier
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EC number: 202-448-4 | CAS number: 95-76-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; purity of test chemical and sex of test animals not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; purity of test chemical and sex of test animals not reported
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,4-dichloroaniline
- EC Number:
- 202-448-4
- EC Name:
- 3,4-dichloroaniline
- Cas Number:
- 95-76-1
- Molecular formula:
- C6H5Cl2N
- IUPAC Name:
- 3,4-dichloroaniline
- Details on test material:
- - Name of test material (as cited in study report): 3,4-Dichloroanilin
- Physical state: solid, crystalline
- Analytical purity: no data
- Lot/batch No.: GEAC 40
- Storage condition of test material: 22°C, dark, under fume hood
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 breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.9-4.0 kg
- Housing: individually in cages, individual ear tags
- Diet: ad libitum, Altromin 2123, 15 g Hay
- Water: ad libitum, deionized, clorinated water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 0.1 mL polyethylenglycol
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Lot/batch no. (if required): Ch-B 2322, Fa. Riedel de Haen AG - Duration of treatment / exposure:
- 4 h
- Observation period:
- 0.5, 1, 24, 48, 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch, dorsal
- Type of wrap if used: non-irritating semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): luke warm water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: average over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: average over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: average over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not irritating
- Executive summary:
Hofmann, T and Weigand, W, 1986
The testing of 3,4 -dichloroaniline for dermal irritation/ corrosion on 3 New Zealand White rabbits according to OECD guideline 404/ EU B.4 did neither result in skin irritation or corrosion. Therefore 3,4 -dichloroaniline needs not to be classified.
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