Chlorodimethyloctadecylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 May - 16 Aug 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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Freie und Hansestadt Hamburg Behörde für Arbeit, Gesundheit und Soziales

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chlorodimethyloctadecylsilane

EC Number:

242-472-2

EC Name:

Chlorodimethyloctadecylsilane

Cas Number:

18643-08-8

Molecular formula:

C20H43ClSi

IUPAC Name:

chlorodimethyloctadecylsilane

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: 48 days (females), 41 days (males)
- Weight at study initiation: 167 - 186 g (females) and 206 - 226 g (males)
- Fasting period before study: overnight before dosing
- Housing: Animals were caged in groups of 2 to 3 animals in MAKROLON cages (type III) furnished with granulated textured wood (Granulate A2, J. Brandenburg, Goldenstedt, Germany)
- Diet: ssniff R/M-H V 1530 diet (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.35 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: not specified

Doses:

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: 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours after dosing and subsequently once daily for fourteen days
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: Microscopic examination of all organs which showed evident lesions was performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50 cut-off

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1/6 animals died within 6 days during the study; according to OECD TG 423 a LD50 cut-off value of 2500 mg/kg bw is derived

Mortality:

Treatment of 2000 mg/kg bw of the test material resulted in the death of one female rat within 6 days.

Clinical signs:

other: No clinical signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

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