Reaction mass of [(2S,3R,4S,5S,6R)-6-[[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] (1S,2R,4aS,6aR,6aR,6bR,8R,8aR,9R,10R,11R,12aR,14bS)-8,10,11-trihydroxy-9-(hydroxymethyl)-1,2,6a,6b,9,12a-hexamethyl-2,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydro-1H-picene-4a-carboxylate and [(2S,3R,4S,5S,6R)-6-[[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] (4aS,6aR,6aS,6bR,8R,8aR,9R,10R,11R,12aR,14bS)-8,10,11-trihydroxy-9-(hydroxymethyl)-2,2,6a,6b,9,12a-hexamethyl-1,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydropicene-4a-carboxylate

Skin irritation / corrosion

Administrative data

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of [(2S,3R,4S,5S,6R)-6-[[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] (1S,2R,4aS,6aR,6aR,6bR,8R,8aR,9R,10R,11R,12aR,14bS)-8,10,11-trihydroxy-9-(hydroxymethyl)-1,2,6a,6b,9,12a-hexamethyl-2,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydro-1H-picene-4a-carboxylate and [(2S,3R,4S,5S,6R)-6-[[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] (4aS,6aR,6aS,6bR,8R,8aR,9R,10R,11R,12aR,14bS)-8,10,11-trihydroxy-9-(hydroxymethyl)-2,2,6a,6b,9,12a-hexamethyl-1,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydropicene-4a-carboxylate

EC Number:

953-451-9

Molecular formula:

C48H78O20

IUPAC Name:

Reaction mass of [(2S,3R,4S,5S,6R)-6-[[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] (1S,2R,4aS,6aR,6aR,6bR,8R,8aR,9R,10R,11R,12aR,14bS)-8,10,11-trihydroxy-9-(hydroxymethyl)-1,2,6a,6b,9,12a-hexamethyl-2,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydro-1H-picene-4a-carboxylate and [(2S,3R,4S,5S,6R)-6-[[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] (4aS,6aR,6aS,6bR,8R,8aR,9R,10R,11R,12aR,14bS)-8,10,11-trihydroxy-9-(hydroxymethyl)-2,2,6a,6b,9,12a-hexamethyl-1,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydropicene-4a-carboxylate

Details on test material:

Container: plastic box (n=6)
Form: powder
Quantity: 180.19g (Container + Content)
Colour: white
Batch: 001
Storage: room temperature
Purity: 99.8% · CAS n°: 34540-22-2
Code number: PH-02/0203

Test animals

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%

Test system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.