Registration Dossier
Registration Dossier
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EC number: 202-426-4 | CAS number: 95-51-2
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
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.4
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-chloroaniline
- EC Number:
- 202-426-4
- EC Name:
- 2-chloroaniline
- Cas Number:
- 95-51-2
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 2-chloroaniline
- Details on test material:
- - Name of test material (as cited in study report): 2-chloroaniline
- Physical state: yellow liquid
- Analytical purity: >99 %
- Lot/batch No.: October 1985
- Storage condition of test material: dark at room temperature 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
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3-2,5 kg
- Housing: air-conditioned, individually, marked by ear tag
- Diet: ad libitum, altromin 2123, 15 g hay
- Water: ad libitum, tap water
- Acclimation period: in house
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:
- 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:
- 14 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
| time of patch removal | 30 -60 min | 24 h | 48 h | 72 h | 7 d | 14 d |
| animal no. | 1/2/3 | 1/2/3 | 1/2/3 | 1/2/3 | 1/2/3 | 1/2/3 |
| erythema score | 1/1/1 | 2/2/2 | 1/2/2 | 1/1/1 | 1/1/1 | 0/0/0 |
| edema score | 0/0/0 | 1/1/1 | 0/0/1 | 0/0/0 | 0/0/0 | 0/0/0 |
Skin
| dry | x/x/x | x/x/x | x/x/x | x/x/x | ||||
|
-/x/- | x/x/- | x/x/x |
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 for skin irritation and corrosion according to EU method B.4 on three New Zealand White resulted in slight irritations that did not fulfill the criteria for classification as irritating according to 83/467/EWG. Therefore o-chloroaniline was classified as not irritating.
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