Registration Dossier
Registration Dossier
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EC number: 639-469-7 | CAS number: 14907-27-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methyl (2R)-2-amino-3-(1H-indol-3-yl)propanoate hydrochloride
- EC Number:
- 639-469-7
- Cas Number:
- 14907-27-8
- Molecular formula:
- C12H15ClN2O2
- IUPAC Name:
- methyl (2R)-2-amino-3-(1H-indol-3-yl)propanoate hydrochloride
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- This in vitro study was performed to assess the corneal irritation and damage potential of D-Tryptophan Methyl Ester HCl by means of the BCOP assay using fresh bovine corneae.
Freshly isolated bovine eyes from at least 9 month old donor cattle were collected from the abattoir.
Test system
- Amount / concentration applied:
- After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test
item D-Tryptophan Methyl Ester HCl, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. - Duration of treatment / exposure:
- 240 minutes
Results and discussion
In vivo
Results
- Irritation parameter:
- other: cornea opacity
- Basis:
- other: in vitro irritation score
- Time point:
- other: 240 min
- Score:
- 67.34
- Irritant / corrosive response data:
- Relative to the negative control, the test item D-Tryptophan Methyl Ester HCl (applied as a 20% (w/v) suspension in saline) caused an increase of
the corneal opacity and permeability. The calculated mean in vitro irritation score was 67.34. According to OECD 437 the test item is classified as
corrosive / severe irritant to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, the test item D-Tryptophan Methyl Ester HCl (applied
as a 20% (w/v) suspension in saline) is corrosive / severe irritant to the eye (CLP/EPA/GHS (Cat 1)).
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