SDBR

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

424-970-3

EC Name:

-

Cas Number:

166255-23-8

Molecular formula:

C16-H14-O3.C6-H16-O3-Si

IUPAC Name:

Triethoxysilylpropyl Dibenzoyl Resorcinol

Test material form:

solid

Details on test material:

Color: Light beige

Specific details on test material used for the study:

Stability: stable
Solubility: toluene, methylene chloride
Storage Conditions: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Eastern Rabbit Breeding Laboratory, Taunton, MA, USA
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2-3 kg
- Housing: individual housing using suspended stainless steel cages. Hardwood chips were used as bedding material
- Diet: controlled diet of a commercial rabbit ration (Agway Prolab, Waverly, NY)
- Water: municipal tap water, ad libitum
There were no known contaminants present in the feed, bedding or water expected to interfere with the test results.
- Acclimation period: minimum of 3 days

ENVIRONMENTAL CONDITIONS (SET CONDITIONS)
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): minimum 10-13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 April To: 11 April 1994

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

The skin site was not abraded, either deliberately, or accidentally during clipping of the fur.

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

Animals were observed for signs of erythema and edema at 30-60 minutes, and then at 24, 48 and 72 hours after the 4 hour exposure period. observations were scored according to the "Draize scale for Scoring Skin Reactions".

Number of animals:

3 males and 3 females

Details on study design:

The test substance was applied under gauze patches measuring 1 square inch. The patches were applied to an intact skin site on each animal. The test substance was kept in contact with the skin for 4 hours by wrapping with an impervious, non-irritating bandage, Vetrap (3M, St. Paul, MN).
At the end of the exposure period, the wrapping was removed and the skin wiped to remove any residual test substance.
Clinical observations were conducted daily, for all clinical signs.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of erythema or edema were noted in any of the test or control sites during the observation period.

Other effects:

There was no evidence of pain and suffering during the observation period. No overt signs of toxicity were evident during the course of the study. All animals survived the test and exhibited a gain in body weight during the observation period

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of a reliable in vivo test it is concluded that SDBR is not irritant (or corrosive) to the skin.