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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February - May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
other: Japan MAFF 8147
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Boron silicate
EC Number:
603-157-9
Cas Number:
12676-29-8
Molecular formula:
H7 B7 Si57 O128
IUPAC Name:
Boron silicate
Details on test material:
Name of the test substance used in the study report: silicon boride oxide
Homogeneity: The test item was homogeneous by visual inspection.
Storage conditions: Room temperature
Physical state / color: Solid / white

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young adult animals of a comparable weight were used.
Acclimatization period of at least 5 days before the beginning of the experimental phase
The animals were housed in fully air-conditioned rooms with temperature of 22°C ± 3°C and relative humidity of 30 – 70%.
Air changes per hour: approx. 10
Day / night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of cage: Makrolon cage, type III
Number of animals per cage: single housing
Feeding: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
Drinking water: Tap water ad libitum

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation period: 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and on the last day of observation.
Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
A check for any dead or moribund animals was made at least once each workday, these records are archived by Bioassay.
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None
Clinical signs:
other: No signs of systemic toxicity or local effects were observed.

Applicant's summary and conclusion