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

Eye irritation

Administrative data

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

240-851-7

EC Name:

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

Cas Number:

16830-15-2

Molecular formula:

C48H78O19

IUPAC Name:

[6-[[3,4-dihydroxy-6-(hydroxymethyl)-5-(3,4,5-trihydroxy-6-methyloxan-2-yl)oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] 10,11-dihydroxy-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

Test material form:

solid

Test animals / tissue source

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%

Test system

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 4

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.

Applicant's summary and conclusion

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.