Registration Dossier
Registration Dossier
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EC number: 203-242-7 | CAS number: 104-83-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- α,4-dichlorotoluene
- EC Number:
- 203-242-7
- EC Name:
- α,4-dichlorotoluene
- Cas Number:
- 104-83-6
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- 1-chloro-4-(chloromethyl)benzene
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: average 3 kg
ENVIRONMENTAL CONDITIONS
- Diet: mümmel Z 222 (Hoeing Kraftfutterwerk Niedersachsen, Verden/Aller)
- Water: tap water (ad libitum)
- Temperature: 19 - 21 °C
- Humidity: 40 - 50 %
- Housing: 1 animal per cage
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Lutrol (Polyethylene glycol)
- Controls:
- no
- Amount / concentration applied:
- 500 mg in Lutrol (Polyethylene glycol)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Coverage: gauze
After 4 hours of exposure the skin was washed with water.
SCORING SYSTEM:
- according to Draize
Scores for erythema and edema after 24 and 72 hours were averaged.
The sum of the average value divided by 2 results in the primary irritating index fot the skin.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Executive summary:
In a dermal irritation study (Bayer AG, 1982) 3 New Zealand White rabbits were dermally exposed to p-chlorobenzyl chloride in Lutrol (Polyethylene glycol). The test site (intact, shaved skin) was covered with gauze 4 hours. Rabbits then were observed for 7 days. Irritations regarding erythema and edema were scored according to the Draize system after 24 and 72 hours.
Skin irritation classified according to OECD Guideline 404: non-irritant
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