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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Feb - 01 Mar 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
Deviations:
yes
Remarks:
rational for starting dose not specified
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
(2002)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bayerisches Landesamt fuer Arbeitsschutz, Arbeitsmedizin und sicherheitstechnik, Munich, Germany
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethoxymethylsilane, SEMICOSIL M2E, Silane, diethoxymethyl-
- Physical state: colourless liquid
- Lot/batch No.: LC 11/05 Pos.2
- Expiration date of the lot/batch: January 12, 2008
- Storage condition of test material: at room temperature, protected from light

Test animals

Species:
rat
Strain:
other: HsdRccHan : WIST
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Weight at study initiation: step 1: 175-181 g, step 2: 185-196g
- Fasting period before study: fasting over night, and 3-4 hours post application
- Housing: in Macrolon cages on altromin saw fiber bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF), ad libitum
- Water: drinking water, municipal residue control, microbiol. controlled periodically), ad libitum
- Acclimation period: adequate

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
- Concentration in vehicle: 0.2 g/mL
- Justification for choice of vehicle: Since the test substance is sensitive to hydrolysis, care was taken to avoid contact to water, as vehicle cottonseed oil was used
- Lot/batch no.: 125K0087

CLASS METHOD
- Rationale for the selection of the starting dose: not specified
Doses:
2000 mg/kg bw in step 1 and 2
No. of animals per sex per dose:
3 females per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing was done before application and once a week thereafter, observations were made several times on day of dosing and once a day thereafter
- Necropsy of survivors performed: yes (gross pathology only, no histopathology)
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortalities or clinical signs of toxicity observed
Mortality:
No mortalities were observed during the study.
Clinical signs:
No clinical sings were observed during the study.
Body weight:
No weight loss was observed during the study period and the weight gain was within the expected range
Gross pathology:
Besides 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 of any step.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In conclusion, under the conditions of the present study, according to OECD 423 and GLP, at the limit concentration of 2000 mg/kg bw no mortalities or clinical signs of toxicity were observed. The test substance does not need to be classified for oral toxicity.