Chlorodimethyloctadecylsilane

Endpoint summary

Description of key information

Acute oral toxicity (OECD 423, rat): LD50 = 2500 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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.

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

A key acute oral toxicity study with chloro(dimethyl)octadecylsilane (CAS 18643-08-8) is available and was performed according to OECD TG 423 and in compliance with GLP (LPT, 2002). In this study following the acute toxic class method three male and female fasted Crl:CD rats were administered a single dose of 2000 mg/kg bw of the test substance (CAS 18643-08-8) in a stepwise procedure via oral gavage. The animals were observed for 14 days after administration. Treatment of 2000 mg/kg bw of the test material resulted in the death of one female rat within 6 days of the study period. No clinical signs of systemic toxicity were noted and all animals showed expected gains in bodyweight during the study period. No abnormalities and no local irritation were found at macroscopic post mortem examination of the animals. Therefore, an acute oral LD50 cut-off value of 2500 mg/kg bw was derived according to OECD TG 423.

Justification for classification or non-classification

The available data on acute oral toxicity of chloro(dimethyl)octadecylsilane do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.