Registration Dossier

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

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:
no effect
Body weight:
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 .