Trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-tetradecyl-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 13 August 2007 to September 17, 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant with international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,3,5,5,5-eptametil-3-tetradeciltrisilossano

IUPAC Name:

1,1,1,3,5,5,5-eptametil-3-tetradeciltrisilossano

Test material form:

liquid: viscous

Details on test material:

- Name of test material: Myristyl Trisiloxane
- Molecular formula:C21H50O2Si3
- Molecular weight: 419 g/mol
- Smiles notation: CCCCCCCCCCCCCC[Si](O[Si](C)(C)C)(O[Si](C)(C)C)C
- InChI=1/C21H50O2Si3/c1-9-10-11-12-13-14-15-16-17-18-19-20-21-26(8,22-24(2,3)4)23-25(5,6)7/h9-21H2,1-8H3
- Substance type:organic
- Physical state:viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation:
- Housing:Housed in ABS - plastic rabbit cages, floor 4200 cm^2
- Diet: Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogen free (TPF)
- Water: Free access to tap water
- Acclimation period:Adequate acclimatization period

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 ± 3 °C
- Humidity (%):55 ± 10%
- Air changes (per hr):10 air change per hour
- Photoperiod (hrs dark / hrs light):12 hours cycle drak/light with artificial light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g per site

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the test results given in conforrmity with the criteria given in Annex VI of the Directive, the substance is not classified

Executive summary:

Myristyl Trisiloxane has been tested for acute dermal toxicity in accordance with OECD, EU amd EPA guidelines.

The test item showed neither irritant nor corrosive effects an the intact skin of 3 rabbits after a contact time of 4h. There were no significant bodyweight changes during the contact and observation period . The Primary Irritation Index (PII) was 0.