Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 June - 23 July 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 1996
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 2001
Deviations:
yes
Remarks:
200 mg/kg bw instead of 300 mg/kg bw was used as starting dose.
GLP compliance:
yes (incl. certificate)
Remarks:
Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Silan 449003 VP (SLM 449003)
- Physical state: colourless-yellowish liquid

- Storage condition of test material: room temperature, protected from light

Test animals

Species:
rat
Strain:
other: HsdBrlHan:WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data available
- Weight at study initiation: 143 - 154 g (step 1), 142 - 152 g (step 2), 151 - 160 g (step 3), 143 - 162 g (step 4)
- Housing: animals were kept in Macrolon cages on Altromin saw fiber bedding
- Fasting period before study: yes (overnight before dosing and 3-4 h after dosing)
- Diet: Altromin 1324 maintenance diet for rats and mice (totally-pathogen-free), ad libitum
- Water: tap water, ad libitum
- Acclimation period: yes, adequate acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 5 ml/kg bw (step 1-4)

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw (step 1-4)
Doses:
200, 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a careful clinical observation was made twice a day on the day of dosing and once a day thereafter, body weights were determined prior to substance application and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination included changes in the skin/fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
The weight gain was within the expected range.
Gross pathology:
Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animal.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In an acute oral toxicity study according to OECD guideline 423 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed up to 2000 mg/kg bw. In conclusion, a LD50 cut-off value of 5000 mg/kg bw was derived.