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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 931-297-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2002)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (6E)-3,5-bis(6-isocyanatohexyl)-6-[(6-isocyanatohexyl)imino]-1,3,5-oxadiazinane-2,4-dione
- EC Number:
- 931-297-3
- Molecular formula:
- (C8H12N2O2)n
- IUPAC Name:
- (6E)-3,5-bis(6-isocyanatohexyl)-6-[(6-isocyanatohexyl)imino]-1,3,5-oxadiazinane-2,4-dione
- Reference substance name:
- 28182-81-2
- Cas Number:
- 28182-81-2
- IUPAC Name:
- 28182-81-2
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: HsdIf:NZW
- Sex: female
- Source: Harlan France, 03800 Gannat, France
- Age at study initiation: young adult animals
- Weight at study initiation: 2.3-2.5 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 25 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The eye-lids were gently held together for about one second in order to prevent loss of the test compound. The eye was not rinsed for at least 24 hours following instillation.
- Observation period (in vivo):
- Examinations were terminated after 72 hours, since all changes had completely subsided then.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Due to animal welfare reasons only one animal was tested at first. If one hour after treatment a severe irritation was not observed, two further rabbits were treated.
PROCEDURE: On the day before the test, both eyes of each animal were examined including fluorescein examination. Only animals with healthy intact eyes were used.
0.1 mL of the pure liquid test substance was placed into the conjunctival sac of one eye ofthe first animal after having gently pulled the lower lid away from the
eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound. The other eye, which remained untreated, served as control. The eye was not rinsed for at least 24 hours following instillation.
SCORING SYSTEM: Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48h, and 72h
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: mean score: 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72h
- Score:
- 0 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: mean score: 1.0
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Conclusions:
Classification: not irritating- Executive summary:
An Acute Eye Irritation/Corrosion test was conducted according to OECD 405. In this study no corneal damage, no iridial inflammation and no conjunctivae chemosis was observed (all scores zero). The substance elicited very slight conjunctival irritation (mean scores conjuncivae redness 0.43). There were no systemic intolerance reactions.
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.
