Registration Dossier
Registration Dossier
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EC number: 619-422-7 | CAS number: 99305-42-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-05-07 to 2006-05-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-Methylenebis(N-butoxycarbonylcyclohexanamine)
- EC Number:
- 619-422-7
- Cas Number:
- 99305-42-7
- Molecular formula:
- C23 H42 N2 O4
- IUPAC Name:
- 4,4'-Methylenebis(N-butoxycarbonylcyclohexanamine)
- Details on test material:
- 4,4'-Methylenebis(N-butoxycarbonylcyclohexanamine) of Degussa AG, batch 03.10.05/B-6320, purity 89.4 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: New Zealand White (SPF)
- Source: Charles River Laboratories, Chatillon sur Chalaronne (France)
- Sex: female
- Age: 9-11 weeks
- Weight at study initiation: 3.4-3.6 kg
- Controls: Adjacent untreated skin
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C +/- 2°C
- Humidity (%): 55 +/- 15 %
- Air changes (per hr): 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours light/12 hours night
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent untreated skin
- Amount / concentration applied:
- 0,5 g undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Total dose applied: 0.5 g test item, undiluted
- Area of exposure: 2.5 x 2.5 cm on dorsal surface of trunk, clipped
- Type of wrap if used: Square gauze + strip of aluminum foil + elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Removal of test substance: Removal of patch, no cleaning -duration of exposure: 4 hours
- first reading time after end of exposure: 1 hour
- Postexposure period: 72 hours
SCORING SYSTEM:
- Scoring system: OECD TG 404; classification: 67/548/EEC and its revisions
EXAMINATIONS
- Examination time points: approx. 1, 24, 48, and 72 hours after patch removal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h; 48 h; 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h; 48 h; 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Irritation scores (individual findings of 3 animals):
- Erythema:
1 hour: 0; 1; 1
24 hours: 0; 0; 0
48 hours: 0; 0; 0
72 hours: 0; 0; 0
- Edema:
1 hour: 0; 0; 0
24 hours: 0; 0; 0
48 hours: 0; 0; 0
72 hours: 0; 0; 0
REVERSIBILITY: complete within 24 hours - Other effects:
- OTHER EFFECTS:
- Systemic effects: No indication
- Body weight development: No remarkable changes
Any other information on results incl. tables
AVERAGE SCORE
- Erythema: 0.67 (1 h); 0.0 (24 / 48 / 72 h)
- Edema: 0.0 (1 / 24 / 48 / 72 h)
REVERSIBILITY: complete within 24 hours
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU: according to European Council Directive 67/548/EEC
- Conclusions:
- According to the study, the test item H12MDU showed no irritant effect on the skin of female rabbits. Classification: not irritating
- Executive summary:
To test the acute skin irritant effect the test item H12MDU was applied to the shaven dorsal skin of rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours. According to the study, the test item H12MDU showed no irritant effect on the skin of female rabbits.
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