Registration Dossier
Registration Dossier
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EC number: 200-774-1 | CAS number: 72-19-5
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 guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- L-threonine
- EC Number:
- 200-774-1
- EC Name:
- L-threonine
- Cas Number:
- 72-19-5
- Molecular formula:
- C4H9NO3
- IUPAC Name:
- L-threonine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11-12 months
- Weight at study initiation: 2.60-3.40 kg
- Housing: individually
- Diet: 120 g/day x animal, standard diet sniff K, special diet for rabbits
- Water: ad libitum
- Acclimation period: 1 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-20.5°C
- Humidity (%): 53-73%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26.07.1993 To: 05.08.1993
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 59.1-61.1 mg
- Concentration: undiluted - Duration of treatment / exposure:
- Single exposure, no washing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: The treated eye was not rinsed.
TOOL USED TO ASSESS SCORE: Cliptrix pencil light (Varta, Hannover, No. 645)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The irritation index is 0.
- Other effects:
- There were no systemic toxic effects after conjunctival application of the test substance. The general condition of the animals was undisturbed.
Any other information on results incl. tables
In the cornea and iris of all three animals no alterations were detected during the observation period.
The conjunctiva of one animal reacted with hyperemia (grade 1) only at the application day. In the two other animals no changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
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