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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 240-702-6 | CAS number: 16652-76-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.11.1995 - 27.11.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- O-benzyl-L-valine toluene-p-sulphonate
- EC Number:
- 240-702-6
- EC Name:
- O-benzyl-L-valine toluene-p-sulphonate
- Cas Number:
- 16652-76-9
- Molecular formula:
- C12H17NO2.C7H8O3S
- IUPAC Name:
- O-benzyl-L-valine toluene-p-sulphonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Chbb:HM (SPF)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated eye of each animal served as control
- Duration of treatment / exposure:
- The Test Articel was administered once into the conjunctival sac of one eye of each animal.
- Observation period (in vivo):
- 13 d
reading time points: 1, 24 48 and 72 h and 4, 5, 6, 7, 10 and 13 d - Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days in one rabbit and 10 days in two rabbits
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
Any other information on results incl. tables
Clinical Signs: No clinical signs were recorded.
Eye Examinations: Eye reactions were observed within 1 hr after application of the test substance. Effects of corneal opacity, redness of the conjunctivae and chemosis was observed in all 3 animals. The iris was not affected. All observed effects were reversible within 10 days.
Body Weight: No body weight changes were observed.
Mortality: No mortality occurred during the treatment and observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye irrit 2, H319
DSD: Xi, R36
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.
