Diethoxy(dimethyl)silane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No test material purity is stated in the study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

only limited information on test procedure and test material identity are given, and no test material purity is stated in the study report, only 2 dose levels tested with 4 animals/dose group

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diethoxy(dimethyl)silane

EC Number:

201-127-6

EC Name:

Diethoxy(dimethyl)silane

Cas Number:

78-62-6

Molecular formula:

C6H16O2Si

IUPAC Name:

diethoxydimethylsilane

Details on test material:

- Name of test material (as cited in study report): Silicone A-164
- Physical state: light yellow liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3 - 5 months
- Diet: ad libitum (not further specified)
- Water: ad libitum (not further specified)

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The trunk of the animals was exposed to the test material.
- Type of wrap if used: polyethylene sheeting

REMOVAL OF TEST SUBSTANCE
- Washing: Excess of the test material is removed after the exposure period to prevent ingestion.
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

8.0 and 16 mL/kg bw

No. of animals per sex per dose:

4 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

16 mL/kg bw

Based on:

test mat.

95% CL:

4.48 - 57.2

Remarks on result:

other: equivalent to: LD50 = 13840 mg/kg bw

Mortality:

No mortality occurred at a dose level of 8.0 mL/kg bw (0/4), whereas 2/4 animals died during the study period when administered the test material at a dose level of 16.0 mL/kg bw.

Clinical signs:

other: No clinical signs of toxicity were recorded during the study period.

Gross pathology:

Gross pathology of dead animals revealed red/pink or orange mottled livers, purple spleens and red kidneys. No abnormalities were found in surviving animals.

Other findings:

Neither erythema nor edema were recorded in 5/8 animals during the study period. 3/8 animals showed erythema and edema formation (grade 1) as well as ecchymosis and scabs after the 14-day study period.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

In summary, the acute dermal LD50 value for male rabbits was considered to be 16 mL/kg bw (corresponding to 13840 mg/kg bw). Therefore, the test substance does not need to be classified for acute dermal toxicity according to Regulation (EC) No 1272/2008.