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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 13 August 2007 to September 17, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant with international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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

Sex:

female

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping
- % coverage:6 cm^2 of the dorsal area
- Type of wrap if used:covered with a ganze patch, which was hell in place wich non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):no


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

Duration of exposure:

4 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 rabbit x dose

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 1, 24, 48 and 72 hourrs alter patch removal.
- Frequency of observations and weighing:Body weights were recorded at the start and at the end of the study.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: no effect

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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.

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 .