Registration Dossier

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:
2006
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

Constituent 1
Chemical structure
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 %

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.