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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 611-342-0 | CAS number: 55974-25-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 405) but full details are not available. Therefore the reliability is with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 7-methoxy-4,4-dimethyl-3,4-dihydro-1H-2-benzopyran-1,3-dione
- EC Number:
- 611-342-0
- Cas Number:
- 55974-25-9
- Molecular formula:
- C12 H12 O4
- IUPAC Name:
- 7-methoxy-4,4-dimethyl-3,4-dihydro-1H-2-benzopyran-1,3-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Isochroman puro
- Physical state: powder
- Lot/batch No.: 01002
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Diet (e.g. ad libitum): Conventional feeding
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 : 12
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL / 0.1 g - Observation period (in vivo):
- 11 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- animal: all animals
- Time point:
- other: 60 mins - 11 days
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- rabbit 1
- Time point:
- other: 60 mins - 11 days
- Score:
- 3
- Reversibility:
- not fully reversible within: end of study
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 60 mins - 11 days
- Score:
- 2.33
- Reversibility:
- not fully reversible within: end of study
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 60 mins - 11 days
- Score:
- 2
- Reversibility:
- not fully reversible within: end of study
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 60 mins - 11 days
- Score:
- 2
- Reversibility:
- not fully reversible within: end of study
- Irritation parameter:
- other: Inflammation score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 60 mins - 11 days
- Score:
- 2
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- other: Inflammation score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 60 mins - 11 days
- Score:
- 1.33
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- other: Flammation score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 60 mins - 11 days
- Score:
- 2
- Reversibility:
- not fully reversible within: end of study
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, according to the Globally Harmonized Classification System, Isochroman puro is considered to be an eye irritating substance of
categorie 2 ( Eye Irrit. 2 ).
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.
