(3-chloropropyl)dimethoxymethylsilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

07.10.1996 to 24.10.1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with 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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloropropyl)diethoxymethylsilane

EC Number:

236-828-6

EC Name:

(3-chloropropyl)diethoxymethylsilane

Cas Number:

13501-76-3

Molecular formula:

C8H19ClO2Si

IUPAC Name:

3-chloropropyl(diethoxy)methylsilane

Details on test material:

- Name of test material (as cited in study report): Dynasylan CPMDEO (3-chloropropyl)methyldiethoxysilan
- Substance type: Chloroalkoxysilane
- Physical state: Liquid
- Stability under test conditions: < 1 year (6 months)
- Storage condition of test material: In closed glass containers in exhaust hood, under inert gas.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: 200-300 g (variation did not exceed ±20% of mean body weight)
- Fasting period before study: No data
- Housing: Individually in Makrolon type II cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07.10.1996 To: 24.10.1996

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsolumbar
- % coverage: 10 % of body surface clipped
- Type of wrap if used: Semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with corn oil
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.03 cm3/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were checked at least daily for mortalities, they were observed for clinical signs soon after dosing and at regular intervals for the remainder of Day 0 (day of dosing), then daily until the end of the 14 day observation period. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examinations.

Statistics:

None done

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no clinical signs.

Gross pathology:

No findings.

Other findings:

There were no other findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal limit study (reliability score 1) conducted to OECD 402 and GLP, the dermal acute LD50 for (3-chloropropyl)diethoxymethylsilane was greater than 2000 mg/kg bw in Wistar rats. There were no significant clinical effects.