Silicic acid, ethyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritative database.

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Acute toxicity in rodents

Author:

U.S. National Library of Medicine

Year:

2010

Bibliographic source:

HSDB

Reference 2

Reference Type:

other: secondary source

Title:

SIDS Initial Assessment Profile.

Author:

United Nations Environmental Programme (UNEP)

Year:

2003

Bibliographic source:

SIDS Initial Assessment Profile, United Nations Environmental Programme (UNEP), 2003.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA TSCA Guideline 798-1100

Principles of method if other than guideline:

Acute dermal toxicity study of the given test chemical in rabbit.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropyltriethoxysilane

EC Number:

213-048-4

EC Name:

3-aminopropyltriethoxysilane

Cas Number:

919-30-2

Molecular formula:

C9H23NO3Si

IUPAC Name:

3-aminopropyltriethoxysilane

Details on test material:

- IUPAC Name - 3-aminopropyltriethoxysilane
- InChI - 1S/C9H23NO3Si/c1-4-11-14(12-5-2,13-6-3)9-7-8-10/h4-10H2,1-3H3
- Smiles - [Si](CCCN)(OCC)(OCC)OCC
- Molecular formula :C9H23NO3Si
- Molecular weight :221.371 g/mole
- Substance type:Organ metallic
- Physical state:liquid
- Purity: >96.1%

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the contact period, excess test material is removed to prevent ingestion.
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

8, 4, 2, and 1 g/kg

No. of animals per sex per dose:

10/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for mortality and clinical signs.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 290 mg/kg bw

Based on:

test mat.

95% CL:

2 900 - 6 340

Mortality:

Days to death for the five male animals in the 8 g/kg group were 1, 1,1,2,2. All other deaths occurred more than 24 hours after dosing.

Clinical signs:

other: Local cutaneous effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, alopecia and scabs. Blood in rectal and urogenital areas apparent in several animals (especially at 4 g/kg). Hemorrhaging under the skin evident a

Gross pathology:

Gross pathologic findings included discolored lungs (red, pink, or mottled), lungs with dark red foci (in one), mottled tan livers, stomachs with dark areas of hemorrhages, stomach with black foci (in one), tan or hemorrhaged kidneys, ureters and urethra with hemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals stained red.

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute dermal LD50 value was considered to be 4290 mg/kg bw, with 95% confidence limits of 2900 to 6340 mg/kg bw, when 10/dose male and female New Zealand white rabbits was treated with the given test chemical by dermal application occlusively.

Executive summary:

Acute dermal toxicity study was conducted in 10/dose male and female New Zealand white rabbitsat the dose concentrations of 8, 4, 2, and 1 g/kg bw as per EPA TSCA Guideline 798-1100 by dermal application occlusively.

After the contact period, excess test material is removed to prevent ingestion.Animals were observed for mortality and clinical signs. Necropsy of survivors performed.

Days to death for the five male animals in the 8 g/kg group were 1, 1,1,2,2. All other deaths occurred more than 24 hours after dosing. Local cutaneous effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, alopecia and scabs. Blood in rectal and urogenital areas apparent in several animals (especially at 4 g/kg). Hemorrhaging under the skin evident at 4 g/kg. Other signs of toxicity included sluggishness, salivation (in one), unsteady gait (in 2), prostration, and diarrhea (in one). Survivors recovered at 2 to 4 days.

Gross pathologic findings included discolored lungs (red, pink, or mottled), lungs with dark red foci (in one), mottled tan livers, stomachs with dark areas of hemorrhages, stomach with black foci (in one), tan or hemorrhaged kidneys, ureters and urethra with hemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals stained red.

Hence, the LD50 value was considered to be 4290 mg/kg bw, with 95% confidence limits of 2900 to 6340 mg/kg bw, when 10/dose male and female New Zealand white rabbits was treated with the given test chemical by dermal application occlusively.