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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-08-06 to 2002-08-21
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Twelve Sprague Dawley rats (SPF Caw) originated from IFFA CREDO (69210 L’Arbresle – France), were used after a 5 to 6-day acclimatisation period. At the beginning of the study, the animals weighted between 174g and 193g (males) and between 148g and 161g (females).

Environmental parameters for the treated group:
- temperature : between 20°C and 23°C
- relative humidity : between 47% and 63%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
As the test product MADECASSOSIDE was presented as powder form, the following solution has been prepared: 2 g of the test product was mixed with distilled water (q.s.p. 10 ml) under magnetic shaking at 40 °C to obtain a solution at 1g/5 ml. The solution was homogenous, colorless and limpide.

The animals of Group 2, received an effective dose of 2000 mg/kg body weight of product MADECASSOSIDE, diluted with distilled water and administered by force-feeding under a volume of 10 ml/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Group 1 (control) : 3 male rats Rm2406 to Rm2408 and 3 female rats Rf2394 to Rf2396
Group 2 (treated) : 3 male rats Rm2409 to Rm2411 and 3 female rats Rf2397 to Rf2399
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No clinical signs related to the administration of the test product were observed.

Any other information on results incl. tables

The product MADECASSOSIDE was administered to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline n0 423 dated March 22nd, 1996 and the test method B.1ter of the E.E.C. Directive no 96/54 dated July 30th, 1996.
No mortality occurred during the study.
No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the product MADECASSOSIDE is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 99/45, the product MADECASSOSIDE must not be classified.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The LD50 of the product MADECASSOSIDE is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 99/45, the product MADECASSOSIDE must not be classified.
Executive summary:

The product MADECASSOSIDE was administered to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline n0 423 dated March 22nd, 1996 and the test method B.1ter of the E.E.C. Directive no 96/54 dated July 30th, 1996.
No mortality occurred during the study.
No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the product MADECASSOSIDE is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 99/45, the product MADECASSOSIDE must not be classified.

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