(3-chloropropyl)triethoxysilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-01-13 to 1995-03-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloropropyl)triethoxysilane

EC Number:

225-805-6

EC Name:

(3-chloropropyl)triethoxysilane

Cas Number:

5089-70-3

Molecular formula:

C9H21ClO3Si

IUPAC Name:

(3-chloropropyl)triethoxysilane

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan
- Age at study initiation: ca. 4 months
- Weight at study initiation: 2593-2918g males, 2561-2793g females
- Fasting period before study: not reported
- Housing: The animals were housed in individual hanging stainless steel wire mesh cages in an animal room.
- Diet: Up to 125g/day Certified Rabbit Chow ~5322, Purina Mills, Inc. St. Louis, Missouri
- Water: ad libitum
- Acclimation period: 25 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-68 (19.4-20°C)
- Humidity: 54 %
- Photoperiod: 12 hours dark/ 12 hours light

IN-LIFE DATES: From: 30/12/1994 To: 07/02/1995

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE

- Area of exposure: dorsal skin removed from hair
- % coverage: 15% of the body surface
- Type of wrap if used: The test site and torso was then wrapped with 8 ply gauze bandaging, occluded with plastic wrap and secured with 3" Dermiform tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The test site was washed with water and dried with disposable towels.
- Time after start of exposure: approximately 24 hours.


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.0163 ml/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 per sex

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed approximately 1, 2 and 4 hours after test article administration on study day 1, then twice daily (morning and afternoon) for 13 additional days (once on the day of the necropsy). Individual body weights were obtained immediately prior to test article administration, on study day 8 and at study termination (day 15).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: A gross necropsy was performed on all animals euthanized (by intravenous sodium pentobarbital overdose) at study termination (day 15); no tissues were saved.

Statistics:

No statistical analysis was reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No deaths occurred during the 14-day study period.

Clinical signs:

other: Desquamation of the test site was noted in four animals. Additionally, a small red raised area on the test site was noted in a single animal. These signs are considered to be due to either the test article and/or treatment.

Gross pathology:

No macroscopic findings were noted at the time of necropsy. The antemortem observations were not confirmed at the time of necropsy.

Other findings:

- Potential target organs: None identified.
- Other observations: No sex specific differences reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study with (3-chloropropyl)triethoxysilane, conducted according to OECD Test Guideline 402 and in compliance with GLP, the LD50 was concluded to be greater than 2000 mg/kg bw in male and female New Zealand White rabbits.