1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-05-10 to 2002-06-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane

EC Number:

223-620-5

EC Name:

1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane

Cas Number:

3982-82-9

Molecular formula:

C28H32O2Si3

IUPAC Name:

1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: Approximately four months
- Weight at study initiation: 1.9-2.1 kg
- Housing: Singly in cages measuring 425 mm x 600 mm x 380 mm
- Diet: Standard diet for Rabbits ssniff K-H V2333, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55± 15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

Four hours

Observation period:

Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions.

Number of animals:

Three males

Details on study design:

TEST SITE
- Area of exposure: 6cm2
- Type of wrap if used: The test site was covered with a gauze patch, held in contact with the skin under semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed

SCORING SYSTEM: According to OECD 404, Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2 and 3

Time point:

other: 60 minutes, 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: 1, 2 and 3

Time point:

other: 60 minutes, 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No erythema or oedema were observed at 60 minutes, 24, 48 and 72 hours

Other effects:

No effects reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the skin irritation study, conducted according to OECD TG 404, and in compliance with GLP, the test material, was reported to be not irritating to the skin of rabbits.

Executive summary:

Three Himalayan rabbits were exposed for four hours to 0.5 ml test material under semi-occlusive conditions on intact skin. The reactions of the intact skin were evaluated 60 minutes and then 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions. No skin reactions or other effects were observed at any of the time points in any of the rabbits.