Silicon carbide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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:

male/female

Details on test animals or test system and environmental conditions:

Body weight of animals at the commencement of the study: female 204 – 221 g and male 243 – 251 g.
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 five days)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test item was applied as a single dose, uniformly over an area which was approx. 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
At the end of the exposure, residual test item was removed by using tap water.

Duration of exposure:

24 hours

Doses:

single dose, 2000 mg/kg body weight

No. of animals per sex per dose:

10 (5 female and 5 male animals were used)

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 clinical signs of toxocity nor skin changes at the application sites were observed throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to an acute dermal toxicity test conducted with silicon carbide (crude and grains) it can be stated that the substance has no acute dermal toxic characteristics. The dermal LD50 in rats was determined to be > 2000 mg/kg body weight.