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EC number: 200-296-3 | CAS number: 56-89-3
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: OECD Guideline study performed under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cystine
- EC Number:
- 200-296-3
- EC Name:
- Cystine
- Cas Number:
- 56-89-3
- Molecular formula:
- C6H12N2O4S2
- IUPAC Name:
- cystine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0,1 g
- Duration of treatment / exposure:
- The treated eye was not rinsed 24 hours after the application.
- Observation period (in vivo):
- The animals were observed for 72 hours after dosing.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The untreated contralateral eye served as control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- ca. 0
- Other effects:
- Neither mortality nor significant clinical signs of toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the present study, a single ocular application of the test item L-Cystine at a dose of 0,1 g produced irritant effects, which were fully reversible within 72 hours.
- Executive summary:
Under the conditions of the present study, a single ocular application of the test item L-Cystine to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item L-Cystine has no obligatory labelling requirement for eye irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item L-Cystine has no obligatory labelling requirement for eye irritation.
According to GHS (Globally Harmonized Classification System) the test item L-Cystine has no obligatory labelling requirement for eye irritation.
Neither mortality nor significant clinical signs of toxicity were observed.
The test item L-Cystine has no obligatory labelling requirement for eye irritation.
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