Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-05-22 to 2006-05-25
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 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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) (H12MDU) of Degussa AG, batch 03.10.05/B-6320, purity 89.4 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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: 3.4-3.9 kg
- Controls: untreated eye
- 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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted
Amount applied: 100 mg
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Comment: not rinsed
ADMINISTRATION/EXPOSURE 
- Preparation of test substance: grinding to a fine powder
- Postexposure period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system:
Based on OECD TG 405. Possible scores:   
Conjunctivae, reddening: 0-3   
Conjunctivae, chemosis: 0-4   
Conjunctivae, discharge: 0-3  
Iris: 0-2   
Cornea, opacity: 0-4   
Cornea, area involved: 1-4
- Classification: 67/548/EEC and its revisions
- Tool used to assess score: not reported ("standard conditions") - a single animal was dosed and the response evaluated. As the response to treatment was considered to be within the acceptable limits further 2 animals were dosed, bringing the group size to 3.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctiva score (redness)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
other: corneal opacity
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 hour
Irritant / corrosive response data:
SCORES
- Iris:  0; 0; 0 (at 1 / 24 / 48 / 72 h)
- Conjunctivae (Redness):  1; 1; 1(at 1 h) // 0; 0; 0 (at 24 / 48 / 72 h)
- Conjunctivae (Chemosis): 0; 0; 0 (at 1 / 24 / 48 / 72 h)
- Discharge: 0; 0; 0 (at 1 / 24 / 48 / 72 h)
- Corneal opacity and area: 0; 0; 0 (at 1 / 24 / 48 / 72 h)
OVERALL 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

SCORES

- Iris:  0; 0; 0 (at 1 / 24 / 48 / 72 h)
- Conjunctivae (Redness):  1; 1; 1(at 1 h) // 0; 0; 0 (at 24 / 48 / 72 h)
- Conjunctivae (Chemosis): 0; 0; 0 (at 1 / 24 / 48 / 72 h)
- Discharge: 0; 0; 0 (at 1 / 24 / 48 / 72 h)

- Corneal opacity and area: 0; 0; 0 (at 1 / 24 / 48 / 72 h)

OVERALL 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: European Directive 67/548/EEC
Conclusions:
According to the study, the test item H12MDU showed no irritant effect on the eye of female rabbits. Classification: not irritating
Executive summary:

To test the acute eye irritant effect the test item H12MDU was applied to the eye lid sac of rabbits. The product was administered undiluted. According to the study, the test item H12MDU showed no irritant effect on the eye of female rabbits.