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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 476-160-4 | CAS number: 54807-34-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- in year 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed to GLP and equiavlent to a guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5,5-dimethylhydantoin
- EC Number:
- 201-051-3
- EC Name:
- 5,5-dimethylhydantoin
- Cas Number:
- 77-71-4
- IUPAC Name:
- 5,5-dimethylimidazolidine-2,4-dione
- Reference substance name:
- dimethylhydantoin
- IUPAC Name:
- dimethylhydantoin
- Details on test material:
- - Name of test material (as cited in study report): 5,5-dimethylhydantoin (DMH)
-physical state: white crystals
- Analytical purity: not stated
- Stability under test conditions: stable in aqueous solution over a week time.
- Storage condition of test material: stored at room temperature, in the darkness, in the same container in which it was received.
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
- Source: Not stated (a registered commercial breeding laboratory)
- Age at study initiation: Not stated
- Weight at study initiation: 2.68-4.30 kg
- Housing: individually housed in stainless steel rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 42-48 %
- Air changes (per hr): 10-15 room air changes
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Test system
- Vehicle:
- not specified
- Controls:
- other: the left eye remaining untreated served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
VEHICLE
- No vehicle used
PREPARATION OF TEST ARTICLE
- Prior to administration, the test material was finely pulverised by using a porcelain mortar and pestle. - Duration of treatment / exposure:
- The upper and lower lids were gently held together for approximately 1 second. The eyes were not washed out.
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days.
Preliminary observation was also carried out before application of test substance. - Number of animals or in vitro replicates:
- 3/sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none
- Anaesthetic: no anaesthetic used.
SCORING SYSTEM: Draize.
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.89
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.5
- Irritant / corrosive response data:
- The application of the substance did not produce any effect to cornea or iris of the eye. A Conjunctivae effect was reversible within 7 days, showing an irritation effect of DMH to the eye with no corrosive effect.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- DMH is not irritating to eyes
- Executive summary:
This study has been performed on DMH (Dimethyl Hydantoin) and has been used for read-across purposes.
The application of the substance did not produce any effect to cornea or iris of the eye. A Conjunctivae effect was reversible within 7 days, showing an irritation effect of DMH to the eye with no corrosive effect.
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.
