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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 922-963-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-05-27 and 2015-07-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-conform and according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of trans-5-hexyldihydro-4-methylfuran-2(3H)-one and cis-5-hexyldihydro-4-methylfuran-2(3H)-one
- EC Number:
- 922-963-4
- Molecular formula:
- C11H20O2
- IUPAC Name:
- Reaction mass of trans-5-hexyldihydro-4-methylfuran-2(3H)-one and cis-5-hexyldihydro-4-methylfuran-2(3H)-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cheonan Yonam College, Laboratory Animal Center
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2.10–2.17 kg
- Housing: individually ((during the quarantine/acclimation and observation periods)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Initial test (June 1 - 8); Confirmatory test (June 1 - 10)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Measurement value: 20.4–21.4
- Humidity (%): Measurement value: 47.5–59.8
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- The eyelid was gently held together for approximately one second.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 1 (initial test), 2 (confirmatory test); males
- Details on study design:
- SCORING SYSTEM: according to OECD scoring system
TOOL USED TO ASSESS SCORE: slit lamp (scores of cornea, iris and conjunctivae); fluorescein paper strips (cornea injury at 24 hours after test substance application)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h/48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- - No abnormal signs or symptoms were observed in any animal throughout the course of the study.
- No clinical signs of pain and distress were evident in three animals immediately after test substance application and at 1, 24, 48 and 72 hours after application.
- All animals exhibited normal body weight gains. The mean body weight gain throughout the observation period was 0.11 kg.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, the test substance, the test substance, did not show any evidence of eye irritation or corrosion in New Zealand White rabbits under the conditions of this study.
- Executive summary:
This study was conducted to evaluate the potential eye irritation/corrosion after a single application of the test substance in three 11-week-old male New Zealand White rabbits.In the initial test, one-tenth (0.1) mL of the test substance (100% test substance) was instilled to the conjunctivae sac of the right eye of one animal after gently pulling over the lower eyelid away from the eyeball. There was a negative response after application in the initial test. Therefore, a confirmatory test was conducted using two animals. Eye irritation was scored according to the method of Draize at 1, 24, 48 and 72 hours after test substance application. Mean 24, 48, 72 hour scores of the three animals were: cornea: 0; iris: 0; conjunctival redness: 0 and chemosis: 0. Based on these results, the test substance is considered to be non-irritating in rabbits' eyes.
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.
