Registration Dossier

Administrative data

Description of key information

According to eye and skin irritation studies performed (OECD 404 and 405), the test item is not irritating to eye and skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, OECD guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2001-18-04
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
3 male albinos rabbits, numerated A3993, A3994 and A3995 of new-Zealand strain, originating from
the Elevage de Gérome (Quartier Labaste – 40260 Linxe) were kept during a 7 -day acclimatisation
period. During the test, the animals weighted between 2.13kg and 2.31kg.
The animals were kept in individual boxes installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19 °C and 23 °C
- relative humidity : between 51% and 68%
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
up to 3 days
Number of animals:
3
Details on study design:
The test product was applied, as supplied, at a dose of 0.5mL, on an undamaged skin area of the right
flank of each animal.
On the left flank was applied, in the same experimental conditions, a dose of 0.5mL of distilled water
on an undamaged skin area.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
The results obtained, in these experimental conditions, enabled to conclude that the test product
LCA01006, according to the scales of interpretation retained :
- is non irritant to skin (PSi =0) according to the classification established in the Journal Officiel de
la République Française dated February 21st, 1982,
- and, must not be classified “R35 : causes severe burns”, “R34 : causes burns” or “R38 :
irritant to skin”, according to the criteria for classification, packaging and labelling of dangerous
substances in compliance with the E.E.C. Directives 67/548 and 93/21.
Executive summary:

The product LCA01006 was applied, as supplied, at the dose of 0.5mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits, according to an experimental protocol established from the O.E.C.D. guideline (n° 404 dated July.17th,1992) and the method B.4 of the directive 92/69/E.E.C. dated December 29th,1992.

No cutaneous reactions (erythema and oedema) were observed in any animal whatever the examination time.

The results obtained, in these experimental conditions, enabled to conclude that the test product LCA01006, according to the scales of interpretation retained : - is non irritant to skin (PSi = 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 in compliance with the E.E.C. Directives 67/548 and 93/21.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OCDE guideline, GLP study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2001-04-18
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three female albinos rabbits, numbered A4008, A4009 and A4010 of new-Zealand strain, originating
from the Elevage de Gérome (Quartier Labaste – F40260 Linxe) were kept during a 6-day
acclimatisation period. During the test, the animals weighed between 2.29kg and 2.45kg.
Animals were kept in individuals boxes, the environmental conditions were :
- temperature : between 19 °C and 23 °C
- relative humidity : between 49% and 63%
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
1hour, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3
Details on study design:
A volume of 0.1 ml of the pure test product was instilled into one eye of each rabbit, the other eye
untreated serving as control.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 4 days
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
- is slightly irritant for the eye (Max. O.I = 9.3) according to the classification established in the
Journal Officiel de la République Française dated July 10th, 1992.
- must not be classified according to the criteria for the classification, packaging and labelling of
dangerous substances in compliance with the E.E.C. Directive n° 67/548 and 93/21.
Executive summary:

The product LCA01006 was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 ml, according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated February 24th, 1987 and the test method B.5 of the directive 92/69/E.E.C. dated December 29th, 1992.

The ocular reactions observed during the study remained slight and only recorded at the conjunctivae level: redness 1 hour after the test product instillation and totally reversible between the 3rd and the 4th day of the test, associated with a slight chemosis in the 3 animals on examination time 1 hour only.

In conclusion, the result obtained, enable to conclude that the test product LCA01006:

- is slightly irritant for the eye (Max. O.I = 9.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.

- must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548 and 93/21.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
According to an OECD test n°404, the substance is not irritating to the skin.

Justification for selection of eye irritation endpoint:
According to an OECD test n°405, the substance is not significantly irritating to the eyes.

Justification for classification or non-classification

The test item is not irritating to eye and skin according to the CLP regulation n°1272/2008/EC