Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 20,2007 to September 13,2007
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.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
476-490-9
EC Name:
-
Cas Number:
286938-65-6
Molecular formula:
C21H50O2Si3
IUPAC Name:
Trisiloxane, 1,1,1,3,5,5,5-Heptamethyl-3-Tetradecyl-
Test material form:
liquid: viscous
Details on test material:
- Name of test material: Intercosil-14M 233268
- Name: Myristil trisiloxane
- Molecular formula:C21H50O2Si3
- Molecular weight: 419 g/mol
- Physical state:viscous liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Harlan Winkelmann GmbH
- Age at study initiation:no data
- Weight at study initiation:
Step 1) 163 - 176 g
Step 2) 175-176 g
- Fasting period before study: Prior to administration food was withheld from the test animals overnight. Following the period of fasting the animals were weighed and the test item was administered. Then the food was withheld for a further 3-4 hours.
- Housing:The animals were barrier maintained (semi-ber) in an air conditioned room. The animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF), ad libitum.
- Water : Free access to tap water
- Acclimation period: Adeguate climatization period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 3 °C
- Humidity (%):55 ± 10%
- Air changes (per hr):10 air change per hour
- Photoperiod (hrs dark / hrs light):12 hours cycle dark/light with artificial light

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Carboxymethylcellulose 1% % (w/v) in aqua ad inj.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 mL/kg body weight.
- Amount of vehicle (if gavage):Carboxymethylcellulose 1% % (w/v) in aqua ad inj.
- Justification for choice of vehicle:The vehicle was Chosen due to its non-toxic characteristics.


MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females x steps
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:animals were weighed prior to the administration and once a week thereafter.
A careful clinical examination was made several times on the day of dosing. Part of this were at least three observations within the first four hours post-dose. Animals were observed once a day thereafter. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern avere examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrificed by an overdosage of pentobarbital.
- Other examinations performed: All animals were subjected to gross necropsy. All gross pathological changes were recorded.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No compound related mortality was recorded for any animat of step 1 or 2.
Clinical signs:
no effect
Body weight:
no effect
Gross pathology:
no effect

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this toxicity test it can be stated that the test item showed no orally toxic characteristics.
According to GHS (Globally Harmonized CIassification System) the test item was classified into Category 5 (LD5Q cut-off: unclassified).
Executive summary:

The acute toxic dose method was performed with the test item . A careful clinical examination was made several times on the day of dosing. Part of this were at least tee observations within the first four hours post-dose. Animals were observed once a day thereafter. In the first step the test item was given at a dose of 2000 mg/kg body weight to a group of 3 female rats (HsdRcdHan : WIST) in a single exposure via oral gavage. Based an the results of the first step and in accordance with the acute toxic dose regime the second step was performed with the same dose in the same manner to a further groups of 3 female rats. No treatment related effect was observed in any animal of step 1 or 2. Following the acute toxic dose regime of OECD 423 no further testing was required. Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were found in any animal of any step. Throughout the 14-days observation period no weight loss was recorded in any animal . The weight gain was within the expected range. Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test item is provided. Considering the reported data of this toxicity test it can be stated that the test item showed no orally toxic characteristics.