Registration Dossier
Registration Dossier
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EC number: 200-795-6 | CAS number: 73-22-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-02-13 to 2007-02-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 405 (adopted 2002)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- L-tryptophan
- EC Number:
- 200-795-6
- EC Name:
- L-tryptophan
- Cas Number:
- 73-22-3
- Molecular formula:
- C11H12N2O2
- IUPAC Name:
- L-tryptophan
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Harlan Italy s.r.l.
Weight: ca. 2000 g
Age: 9 – 11 weeks
Acclimatisation period: at least 10 days
Housing: individually in stainless steel cages equipped with grid floor
Diet: STANRAB (P) SQC ad libitum
Water: ad libitum
Environmental conditions:
Temperature (°C): 19 ± 2
Relative humidity (%): 55 ± 15
Photoperiod (hrs dark / hrs light): 12 / 12 by fluorescent tubes
Air changes (per hr): 15-20
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
Amount applied: 100 mg - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- up to 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No rinsing
SCORING SYSTEM
According to guideline
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Irritant / corrosive response data:
- Slight redness, chemosis and discharge (scores of 1) were observed in the 3 animals at the 1 h examination. The ocular reactions were reversible in all animals within 24 h after application.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute eye irritation of L-tryptophan was investigated with rabbits in a GLP study according to OECD guideline 405. There was no indication of a systemic effect of treatment. Changes in body weight were not remarkable. A slight irritation was observed at the 1 h examination in all animals, but recovery occurred at the 24 h examination. Therefore, L-tryptophan can be classified as not eye irritating.
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