Registration Dossier
Registration Dossier
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EC number: 211-519-9 | CAS number: 657-27-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 72 hours
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conform OECD Guideline 405 under GLP conditions. No deviations reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
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:
- Lysine hydrochloride
- EC Number:
- 211-519-9
- EC Name:
- Lysine hydrochloride
- Cas Number:
- 657-27-2
- Molecular formula:
- C6H14N2O2.ClH
- IUPAC Name:
- lysine hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): Lysine HCl crystals
- Substance type: white to pale yellow crystals
- Physical state: solid
- Analytical purity: 99%
- Lot/batch No.: CP trial 13-14 November 2001
- Expiration date of the lot/batch: I November 2004
- Storage condition of test material ambient temperature, storage under dry conditions
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lagro. France
- Age at study initiation: ca 9 weeks
- Weight at study initiation: ca. 1800 g.
- Housing: individually in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C.
- Humidity (%): 30-70%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- not specified
- Remarks:
- vehicle not reported
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 0.1 ml equals ca. 0.06 g
VEHICLE
- Amount(s) applied (volume or weight with unit): not reported - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with water
- Time after start of exposure: 1 hour
SCORING SYSTEM:
See appendix I of TNO Report 4415/18
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Lysine HCl crystals were tested in three albino rabbits according to OECD Guideline 405, under GLP conditions. Lysine HCl crystals caused reversible slight to moderate redness (at t = 1, 24, 48 hours), and slight swelling of the conjunctivae (at t = 1, 24 hours). Lysine HCl crystals caused reversible slight to severe discharge (at t = 1 hour). Lysine HCl crystals are considered not irritating.
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