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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 608-681-1 | CAS number: 319-24-4
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- and Guideline-Study with no or minor deficiencies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EG-Guideline B.5. Acute Toxicity Eye Irritation of the Directive 92/69/EWG
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methyl 2-amino-5-fluorobenzoate
- EC Number:
- 608-681-1
- Cas Number:
- 319-24-4
- Molecular formula:
- C8 H8 F N O2
- IUPAC Name:
- methyl 2-amino-5-fluorobenzoate
- Test material form:
- other: yellow solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Chemical Pharmaceutical factory Dr. K. Thomae
Age at study initiation: Age 3-5 month
Weight at study initiation: 2.5-3.6 kg
Housing:
fully air conditioned rooms, separate cages
Temperature: 20± 3 °C
Humidity: 50 +/- 20 %
Lightning time: 12 hours daily
Acclimatisation: 7 days
water: ad libitum
Diet: Altromin 2123 ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as a control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Up to 72 hours
- Number of animals or in vitro replicates:
- 3 per group
- Details on study design:
- The treated eyes were washed out with isotonic saline at approx. 37 °C.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 2 days after p.a. all irritations were reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The testing showed that the test item is not irritating to the eye.
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.
