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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 605-404-6 | CAS number: 16535-55-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- skin and eye irritation tests performed on the same individual
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- skin and eye irritation tests performed on the same individual
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (2,4-dioxo-1,3-benzoxazin-7-yl) ethyl carbonate
- EC Number:
- 605-404-6
- Cas Number:
- 16535-55-0
- Molecular formula:
- C11 H9 N O6
- IUPAC Name:
- (2,4-dioxo-1,3-benzoxazin-7-yl) ethyl carbonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 88.2 mg (volume of approx. 0.1 ml)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- A sample of 88.2 mg (a volume of 0.1 ml) of V194024 was instilled in the conjunctival sac of one eye of an albino rabbit (New Zealand White, SPF-quality) after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Draize score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 6 - <= 20
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The eye irritation of V194024 was tested on the rabbit using the OECD 405 test protocol. Instillation of 88.2 mg into an eye resulted in irritation of the cornea and iris 24 hours after instillation and in irritation of the conjunctivae, which had completely resolved within 7 days after instillation.
V194024 was considered mildly irritating to the rabbit eye (Category 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.
