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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September - October 2011
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:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation 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
Purity: >90%
Expiry date: 29-Jul-2013
Storage Conditions: At room temperature (20 ± 5°C), protected from direct sunlight

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age at exposure: 9 weeks
Body weight range at exposure: males: 240.6 to 258.1 g; females: 163.8 to 189.1 g
Housing conditions: Optimal hygienic conditions (OHC) inside a barrier system. Air-conditioned with 10 - 15 air changes per hour, continuously monitored environment with a temperature range of 22 ± 3°C, a relative humidity range of 30 - 70% and a 12 hour fluorescent light / 12 hour dark cycle.
The animals were housed in groups of 5 of the same sex in Makrolon type-IV cages with wire mesh tops and standard softwood bedding including paper enrichment.
Animals had ad libitum access to a pelleted standard Harlan Teklad 2914C rat maintenance diet, except during the period when the animals were restrained in exposure tubes. Community tap water from Füllinsdorf was available ad libitum in water bottles, except during the period when they were restrained in exposure tubes.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.5 mg/l
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
No statistical analysis was performed as only one group was allocated to the study.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.5 mg/L air
Remarks on result:
other: gravimetrically determined mean aerosol concentration.
Mortality:
All animals survived the scheduled observation period.
Clinical signs:
other: Ruffled fur was recorded in all animals from the end of exposure until test day 3. Labored breathing was seen in two males starting during the last hour of exposure and lasting up to test day 2. There were no clinical signs from test day 4 of the observat
Body weight:
From test day 1 to test day 2, slight to marked body weight loss was noted in all males and four females. Stagnation of body weight was observed in the remaining female during this period. Thereafter normal body weight development was recorded in these animals.
Gross pathology:
There were no macroscopic findings.

Applicant's summary and conclusion