Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 20,2007 to August 25,2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant with international guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA 712-C-98-195 (August 1998).
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation: no data
- Weight at study initiation:2.7, 4.9, 3.6 kg
- 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 pathogene 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 dark/light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml

Duration of treatment / exposure:
The test item was applied in a single dose in the conjunctival sac
Observation period (in vivo):
24,48,72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Approximately 24 hours before the test and immediately prior to application both eyes of the test animals were examined. A health inspection was performed to ensure the good state of health of the animals.

TOOL USED TO ASSESS SCORE:
72 hours after administration the treated eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo®, Lot H 602).

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Other effects:
None of the animals showed signs of irritation post instillation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item produced no irritating effects.
Executive summary:

Myristyl Trisiloxane has been tested for eye irritation in accordance with OECD, EU amd EPA guidelines. Considering the reported data of this irritation study it can be stated that the test item produced no irritating effects.

According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Direttive 93/21 EEC) the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.