Silicon carbide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 November 2007 - 29 February 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study generated according to internationally accepted testing guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: EPA OPPTS 870.1000 (Acute toxicity testing background)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Silicon carbide

EC Number:

206-991-8

EC Name:

Silicon carbide

Cas Number:

409-21-2

Molecular formula:

SiC

IUPAC Name:

methyl-λ¹-silanylidyne

Test animals

Species:

rat

Strain:

other: HsdRccHan: WIST rats (Full-Barrier)

Sex:

female

Details on test animals or test system and environmental conditions:

Step 1: Body weight at the commencement of the study: 169 – 200 g;
Step 2: Body weight at the commencement of the study: 175 – 186 g.
The age of the animals at the time of delivery was 7-8 weeks. The age of the animals at the start of the study was 8-9 weeks.
The animals were derived from a controlled full barrier maintained breeding system (SPF).
The animals were barrier maintained (semi-barrier) in an air conditioned room
- Temperature: 22 +/- 3 °C
- Rel. humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- The animals were kept in Macrolon cages on Altromin saw fiber bedding
- Certificates of food, water and bedding are filed at BSL Bioservice
- Adequate acclimatization period (at least 5 days)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The test item was administered in a single dose by gavage using an intubation cannula, at a volume of 10 mL/kg body weight.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 (3 animals were used for each step)

Control animals:

no

Results and discussion

Effect levels

Dose descriptor:

other: NOAEL

Effect level:

2 000 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: No treatment related effect was observed.

Gross pathology:

Beside acute injection of blood vessels in the abdominal region, w hich is due to the euthanasia injection, no specific gross pathological changes were found in any animal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item showed no orally toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test item w as classifiedin to Category 5 (LD50 cut-off: unclassified).

Executive summary:

According to an acute oral toxicity test conducted with silicon carbide (crude and grains) it can be stated that the substances shows no orally toxic characteristics. The oral LD₅₀in rats was determined to be > 2000 mg/kg body weight.