Registration Dossier

Administrative data

Description of key information

The results obtanied, under these experimental conditions, enable to conclude that the test item LCA08002, according to the scales of interpretation retained :

- Is non irritant to skin (PS1=0) according to the classification established in the Journal Officiel de la République Française dated February 21st, 1982,

and, must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrases are required.

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



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.


Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-05-13 to 2008-05-23
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste -F40260 Linxe)
- Age at study initiation: 12 to 13 weeks old
- Weight at study initiation: 2.72 kg to 3.12 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): 19°C to 22°C
- Humidity (%): 34% to 54%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12h hours daily

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5g pure
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 75 hours
Number of animals:
3
Details on study design:
Approximately 24 hours before the test, the rabbits backs and flanks were shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm2.
As no tissue destruction was notedafter a treatment during 3 minutes and 1 hour, the test item was applied, as supplied, at a dose of 0.5g, on an undamaged skin area of one flank of each animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape. After the removal of the patch, the treated area was rinsed with distilled water.
On the opposite flank an untreated area was served as the control.
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the dirst treated animal, two additional animals were treated during 4 hours.
The skin reaction were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
This examination consists in assessing the irritation reactions in the treated zone, compared to a control area.
If no reaction is observed 72 hours after the treatment, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D14 in order to determine the reversibility character of the lesions observed.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
no data
Remarks:
not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritant / corrosive response data:
No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours)
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: the Journal Officiel de la République Française dated February 21st, 198
Conclusions:
The results obtanied, under these experimental conditions, enable to conclude that the test item LCA08002, according to the scales of interpretation retained :
- Is non irritant to skin (PS1=0) according to the classification established in the Journal Officiel de la République Française dated February 21st, 1982,
and, must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrases are required.
In accordance with the Globaly Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 "irritant". No signal word and hazard statement are required.
Executive summary:

The test item LCA08002 was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of the three rabbits. The experimental protocol was established from the OECD guideline n°404 dated April 24th, 2002 and the test method B.4 of the directive n°2004/73/EC.

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours).

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

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
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)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
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
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification