Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 619-422-7 | CAS number: 99305-42-7
Eye irritation
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:
- 2 006
- 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
- 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 %
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
