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Description of key information

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
Study period:
2002-06-08 to 2002-09-08
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 male albinos rabbits, numerated A4789, A4790 and A4791 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 2.23kg 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 22 °C
- relative humidity: between 47% and 52%
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
The product MADECASSOSIDE was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing.
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
Number of animals:
3
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Irritant / corrosive response data:
Primary skin irritation: PSi = 0.2
1 hour after removal of the patch: 0/3 animals with skin reaction
24 hours after removal of the patch: 1/3 animals with skin reaction (slight erythema)
72 hours after removal of the patch: 0/3 animals with skin reaction

The product MADECASSOSIDE was applied, as supplied, at the dose of 0.5g, 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 E.E.C. directive n° 92/69 dated December 29th,1992.
It was only noted a slight erythema, in 1 animal on the reading time 24 hours.
The results obtained, in these experimental conditions, enabled to conclude that the test product MADECASSOSIDE, according to the scales of interpretation retained:
- is non irritant to skin (PSi = 0.2) 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 96/45.

Interpretation of results:
other: not classified
Conclusions:
The results obtained, in these experimental conditions, enabled to conclude that the test product MADECASSOSIDE, according to the scales of interpretation retained:
- is non irritant to skin (PSi =0.2) 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 99/45.
Executive summary:

The product MADECASSOSIDE was applied, as supplied, at the dose of 0.5g, 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 E.E.C. directive n° 92/69 dated December 29th,1992.
It was only noted a slight erythema, in 1 animal on the reading time 24 hours.
The results obtained, in these experimental conditions, enabled to conclude that the test product MADECASSOSIDE, according to the scales of interpretation retained:
- is non irritant to skin (PSi = 0.2) 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 96/45.

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
Study period:
2002-08-11 to 2002-18-14
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three female albinos rabbits of New Zealand strain, numbered A4825, A4826 and A4827, originating from the Elevage de Gérome (Quartier Labaste – F40260 Linxe) were kept during a 5 day acclimatisation period. During the test, the animals weighed between 2.20kg and 2.37kg.
Animals were kept in individuals boxes, the environmental conditions were:
- temperature: between 19 °C and 21 °C
- relative humidity: between 45% and 52%
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
A quantity of 0.1 g of the pure test product was instilled into one eye of each rabbit
Number of animals or in vitro replicates:
3
Details on study design:
Ocular examinations were performed on both right and left eyes 1 hour after instillation and 24, 48 and72 hours later.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The ocular reactions observed during the study remained slight and only recorded at the conjunctivae level: very slight redness in the 3 animals on examinations times 1, 24 and 48 hours associated with a very slight chemosis in 2 animals only at the reading time 1 hour.

The result obtained, in these experimental conditions, enable to conclude that the test product MADECASSOSIDE:
- 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.
- 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. Directive n° 67/548 and 99/45.


 


NOTE :
If no reaction is observed at 72 hours (D3) after instillation, the study is finished. In case of persistent reactions, additional observations can be carried out at Day 4 (D4), to Day 21 (D21) in order to determine the reversible character of the lesions observed.

Interpretation of results:
other: not classified
Conclusions:
The result obtained, in these experimental conditions, enable to conclude that the test product MADECASSOSIDE:
- 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.
- 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. Directive n° 67/548 and 99/45.
Executive summary:

The product MADECASSOSIDE was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 g, 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 E.E.C. directive n° 92/69 dated December 29th, 1992.
The ocular reactions observed during the study remained slight and only recorded at the conjunctivae level: very slight redness in the 3 animals on examinations times 1, 24 and 48 hours associated with a very slight chemosis in 2 animals only at the reading time 1 hour.
In conclusion, the result obtained, in these experimental conditions, enable to conclude that the test product MADECASSOSIDE:
- 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.
- 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. Directive n° 67/548 and 99/45.

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

Additional information

Justification for classification or non-classification

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