Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb 6th to 21st 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, performed in conformity with GLP-principles
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): LZ1780 (identical with L-Carnitine-L-Tartrate)
- Physical state: white, crystalline powder
- Lot/batch No.: 21205
- Stability under test conditions: stable
- Storage condition of test material: ambient temperature
- Expiry date: 09 December 2007

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Sex: 3 males
- Age and body weight: animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
- Housing: individual housing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
On average, 92.2 mg (range 90.3 - 94.2 mg) of the test substance (a volume of approximately 0.1 ml)
Duration of treatment / exposure:
Animals were treated by instillation of, on average, 92.2 mg of the test substance in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The other eye remained untreated and served as the reference control.
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and/or 7 days after instillation of the test substance.
Number of animals or in vitro replicates:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 72 days
Other effects:
Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 72 hours in two animals and within 7 days in the remaining animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be non-irritant to rabbit eyes. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation according to the European CLP-Regulations (GHS).
Executive summary:

The test item was tested for eye irritation on rabbits according to OECD-Guideline No. 405, EU-Testing Method B.5 and in conformity with GLP-principles. The study was performed from 6 February - 21 February 2006.

The test item was found to be non-irritant to rabbit eyes. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation according to the European CLP-Regulations (GHS).