Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22. August 2012 - 07. November 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented guideline study under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name: Initiator 94
Batch: 004IN11
according to certificate of analysis and its addendum of 1. August 2012:
purity: 32% (main component and active species: benzpinakolsilylethers
further composition: Phosphoric acid tributylester (Tributylphosphate) 19.3 %,
1,2-Benzenedicarboxylic acid-di-2-propenylester (Diallylphthalate) 8.7%;
Methylbenzene (toluol) 12.9%;
Diphenylmethanone (Benzophenone) 12.4 %;
1,1,1,1-Tetraphenylethane-1,2-diol (Benzpinakol) 14.6%
form: liquid
colour: brown
odour: aromatic
density: 1.13 g/cm3 at 20°C
Production date of batch: 16.05.2011
Expiry date of batch: 01.02.2013

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Sprague Dawley rats (SPF Caw) supplied by Elevage Janvier, France.
- Age at study initiation: 8 weeks
- Weight at study initiation: 190 g to 203 g
- Fasting period before study: food was removed on D-1.
- Housing: in a group of three in solid bottomed clear polycarbonate cages with stainless steel mesh lid, sawdust bedding changed at least 2 x weekly.
- Diet: foodstuff (M20, SDS) (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10 to 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE:
- Justification for choice of vehicle: no vehicle used
Doses:
2000 mg/kg (1.76 ml/kg body weight, calculated based on the density)
No. of animals per sex per dose:
6
Control animals:
other: comparison to historical control (last control during May/June 2012).
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: every day for 14 days. on first day: D0 + 30 min, D0 +1h, D0 + 3h, D0 + 4h.
- Frequency of weighing: D0, D2, D7 and D14
- Necropsy of survivors performed: yes
- Observations: - spontaneous activity, Preyer`s reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lacrymation, Righting reflex, Back hair appearance.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 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 mortality at a limit dose of 2000 mg/kg bw.
Body weight:
A higher body weight gain was noted in the treated animals within the 14 days post treatment compared to the historical control group.
Other findings:
In the first hours of the test after treatment:
- decrease in spontaneous activity (6/6)
- decrease in muscle tone (1/6)
- increased salivation (2/6)
- increased lacrymation (1/6)
- piloerection (2/6)

The animals recovered a normal behaviour at 24 hours post-dose.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Initiator 94 was administred to 6 female Sprague Dawley rats at a single dose of 2000 mg/kg bw. via gavage according to OECD 423/ B.1tris (EC) regulation No. 440/2008 under GLP. No mortality occured during the study. Macroscopic examination of the animals at the end of the study did not reveal treatment releated changes in comparison to historic controls.

LD0/LD50 is higher than 2000 mg/kg bw.