Dichlorodicyclopentylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-01-21 until 1997-03-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD test under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Silane CP 2
- Physical state: liquid
- Analytical purity: 96.3% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 10466 QB
- Expiration date of the lot/batch: 1997-12-01
- Stability under test conditions: stable in corn oil up to 24 hours
- Storage condition of test material: in original container, at room temperature, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories LTD; CH-4414 Füllinsdorf
- Age at study initiation: males 8 weeks; females 10 weeks
- Weight at study initiation: males 200 - 209 g; females 176 - 187 g
- Fasting period before study: approx. 16 hours
- Housing: standard laboratory conditions; groups of five animals in Makrolon type-4 cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week under laboratory conditions, after health examination


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 ml application volume; 0.2 g test substance/ml vehicle
- Justification for choice of vehicle: stability of the test substance

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male/5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: five times during day 1 and once daily during day 2-15 examination for clinical signs/mortality; body weights were recorded on day 1 before administration and on days 8 and 15
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, mortality, body weights, necropsy

Statistics:

not possible, limit test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality has been observed.

Clinical signs:

Males: sedation (5 animals), ventral recumbency (5), hunched posture (3), dyspnea (5), ruffled fur (4); all symptoms reversible after 3 days
Females: sedation (5 animals), ventral recumbency (5), dyspnea (5), ruffled fur (5); all symptoms reversible after 7 days

Body weight:

Males (mean): day 1: 205.4 g; day 8: 240.6 g; day 15: 268.1 g
Females (mean): day: 1 184.2 g; day 8: 201.8 g; day 15: 215.7 g

Gross pathology:

No findings noted.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.

Executive summary:

A group of five male and five female Wistar rats was treated with Silane CP 2 at 2000 mg/kg by oral gavage. The test substance was suspended in corn oil (vehicle). No deaths occurred during the study. General signs of toxicity such as sedation, dyspnea, ventral recumbency, hunched posture and ruffled fur were observed. These singns were reversible within 3 days (males) and 7 days (females) after exposure, respectively. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.