D-Gluconic acid, 2,3,4,6-tetrakis-O-(trimethylsilyl)-, .delta.-lactone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 - 11 Aug 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3R,4S,5R,6R)-3,4,5-tris[(trimethylsilyl)oxy]-6-{[(trimethylsilyl)oxy]methyl}oxan-2-one

EC Number:

608-732-8

Cas Number:

32384-65-9

Molecular formula:

C18 H42 O6 Si4

IUPAC Name:

(3R,4S,5R,6R)-3,4,5-tris[(trimethylsilyl)oxy]-6-{[(trimethylsilyl)oxy]methyl}oxan-2-one

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test Animals
- Female Crl:KBL (New Zealand White) strain rabbits were obtained from Charles River Laboratories
- The rabbits were in a body weight range of 3.0 – 3.4 kg on Day 1.
- Rabbits were approximately 2 months on Day 1

CONDITIONS
- Municipal tap drinking water (Stadtwerke Biberach) was available ad libitum via automated
water supply.
- The animals were offered ad libitum pelleted dry food (Kliba No. 3413.0.25,
Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland). The lot number of the food is
documented in the raw data. The food is analyzed regularly for major nutritive components
and significant contaminants by the manufacturer.
- The animal rooms were designed to permit approximately of 10 air changes per hour. The target temperature and Relative Humidity ranges 22 °C ± 2 °C and 45 % - 75 %, respectively.
- Light/darkness cycle: 12/12 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

approx. 500 μL per treatment site

Duration of treatment / exposure:

4h

Observation period:

1, 24, 48 and 72h

Number of animals:

3 females

Details on study design:

During the pre-test period, the health status of the animals was observed daily by clinical
inspection and recorded.
On Day 1 in the morning, dermal administration of approx. 500 μL per treatment site of the
BI 10773 TMS-LACTON formulation was performed. The site of administration was
occluded by muslin tissue and fixed by a non-skin-irritating plaster.
At the end of the indicated exposure time, the test item was removed from the respective site of administration, the skin was carefully cleaned with demineralized water to completely remove the test item.
Treated skin sites were examined 1, 24, 48 and 72 h post cessation of the exposure and
evaluated according to the criteria given in OECD Guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72

Remarks on result:

other: No macroscopic signs of irritation or corrosion at the sites of exposure or other skin areas beyond these sites and no signs of systemic toxicity were observed.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72

Remarks on result:

other: No macroscopic signs of irritation or corrosion at the sites of exposure or other skin areas beyond these sites and no signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

Under the conditions of the present study, a single dermal administration of BI 10773 TMSLACTON,
a starting material for BI 10773 XX, was well tolerated in rabbits. Thus, according
to the Globally Harmonized Hazard Classification and Labeling Scheme (GHS), the test item
was not classified.