O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate

Endpoint summary

Description of key information

Skin irritation / corrosion:

The results obtained, in these experimental conditions, enabled to conclude that the test item, 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 99/45.

 

Eye irritation:

The result obtained, in these experimental conditions, enable to conclude that the test item:

- is slightly irritant for the eye (Max. O.I = 10.7) 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.

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:

June 8, 2002 - September 9, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: 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 A4792, A4793 and A4794 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 2.28kg and 2.47kg.

The animals were kept in individual boxes installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 20 °C and 22 °C
- relative humidity : between 46% and 53%

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The test product was applied, as supplied, at a dose of 0.5g, 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.

Observation period:

The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed at 72 hours (D3), the test is completed. In case of persistent reactions, additional observations can be carried out from Day 4 (D4) to Day 14 (D14) if necessary in order to determine the reversible character of the lesions observed.

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

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

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained, in these experimental conditions, enabled to conclude that the test item, 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 99/45.

Executive summary:

SUMMARY AND CONCLUSION OF THE STUDY

 

The test item 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.

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 item, 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 99/45.

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:

August 11, 2002 - August 14, 2002

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: 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 A4828, A4829 and A4830, 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 2.09kg and 2.39kg.

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, the other eye untreated serving as control.

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1 hour after instillation and 24, 48 and 72 hours later.
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.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

2

Irritant / corrosive response data:

The individual and mean scores obtained during the study are shown in tables 1 to 5 hereafter.
The ocular reactions observed during the study remained slight and only recorded at the conjunctivae level: slight redness in the 3 animals on examinations times 1, 24 and 48 hours associated with a slight to moderate chemosis only at the reading time 1 hour.

Interpretation of results:

GHS criteria not met

Conclusions:

The result obtained, in these experimental conditions, enable to conclude that the test item:
- is slightly irritant for the eye (Max. O.I = 10.7) 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:

SUMMARY AND CONCLUSION OF THE STUDY

 

The test item 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: slight redness in the 3 animals on examinations times 1, 24 and 48 hours associated with a slight to moderate chemosis only at the reading time 1 hour.

In conclusion, the result obtained, in these experimental conditions, enable to conclude that the test item:

- is slightly irritant for the eye (Max. O.I = 10.7) 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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available