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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:
2008-05-19 to 2008-06-02
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): LCA08002
- Substance type: Lipoaminoacid
- Physical state: White powder
- Analytical purity: 100%
- Lot/batch No.: 1549 JG
- Expiration date of the lot/batch: 2009-04-10
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste -F40260 Linxe)
- Age at study initiation: 13 to 14 weeks old
- Weight at study initiation: 2.91 kg to 3.20 kg
- Housing: Individual box
- Diet (e.g. ad libitum): SDS-C15 supplied freely
- Water (e.g. ad libitum): tap-water from public distribution system-supplied freely
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C to 22°C
- Humidity (%): 30% to 50%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12h hours daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1g as supplied
Duration of treatment / exposure:
1 instillation without physical removal
Observation period (in vivo):
1 hour, 24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
3
Details on study design:
0.1g of the test item was instilled, as supplied, into the conjuctival sac of one eye. The other eye remained untreated as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D4, two additional animals were treated.

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
conjonctivae, iris and cornea
Basis:
mean
Time point:
other: 1 hour
Score:
16.3
Max. score:
16.3
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Irritant / corrosive response data:
The ocular reactions observed during the study have been slight to moderate, and totaly reversible in the three animals:
- at the conjonctivae level; a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between D4 and D7, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D2 and D5;
- at the corneal level: a slight opacity, registered 1 hour after the test item instillation in two animals,
- at the iris level: a congestion noted 1 hour after the test item instillation in one animal.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Journal Officiel de la République Française dated July 10th, 1992
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item LCA08002:
- Is Moderately irritant for eye (Max. O.I = 16.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- And, must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives n°67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globaly Harmonized System (COM(2007)355 final), the test item must not be classified in category 2. No signal and hazard statement are required.
Executive summary:

The test item LCA08002 was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1g. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC

The ocular reactions observed during the study have been slight to moderate, and totaly reversible in the three animals:.

- at the conjonctivae level; a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between D4 and D7, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D2 and D5;

- at the corneal level: a slight opacity, registered 1 hour after the test item instillation in two animals,

- at the iris level: a congestion noted 1 hour after the test item instillation in one animal.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item LCA08002 must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives n°67/548, 2001/59 and 99/45. No symbol and risk phrase are required..

In accordance with the Globaly Harmonized System (COM(2007)355 final), the test item must not be classified in category 2. No signal word and hazard statement are required.