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Toxicological information

Eye irritation

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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:
2002

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

Constituent 1
Chemical structure
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

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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