Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term toxicity to fish
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
19 - 23 September 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
an additional dose of 10000 mg/L of the substance was tested according to the requirements of the German "Umweltbundesamt"
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
112945-52-5
EC Number:
601-216-3
Cas Number:
112945-52-5
IUPAC Name:
112945-52-5
Details on test material:
- Name of test material (as cited in study report): Aerosil 200; hochdisperses, amorphes Siliziumdioxid (high dispersive, amorphous silicon dioxide);
two CAS numbers are given in the primary study: 7631-86-9 and 112945-52-5. The first number is the general CAS No. which includes all forms of silicas (e.g. also crystalline and natural forms), the second number is the special number for "Silica, amorphous, fumed, crystalline-free"
- Substance type: insoluble, white, fluffy powder
- Physical state: powder, hydrophilic
- Analytical purity: appr. 100%
- Impurities (identity and concentrations): Al2O3, TiO2, HCL < 0,2%
- Lot/batch No.: Aerosil 200, UB 3391, S 31702 1/C
- Stability under test conditions: insoluble powder, supension homogeneous and milky of colour throughout test conditions
- Storage condition of test material: stored at room-temperature
- Other:
MAK-value: 4 mg total dust/m3
not explosive, flamable, or corrosive

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
The nominal concentrations of 1000 and 10000 mg/l were tested, and result refers to the loading. Because of the poor water solubility of the test substance, the test solution was stirred for 20 h, then allowed to stand for 4 h before testing; the resulting suspensions at the beginning of the test were homogeneous and milky. At the end of the test the suspension was still homogeneous and milky, in addition a layer of white, starchy flocks on the bottom of the vessels was observed.
Concentrations can be described as loading rate. Analytical determination was not meaningful due to concomitance of dissolved and undissolved particles (saturated conditions).

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Source: Commercial hatchery M.B. Ruysbroek B.V. (Noordvliet 159, Maassluis)
- Length at study initiation (length definition, mean, range and SD): 2.2 ± 0.2 cm (SD)
- Weight at study initiation (mean and range, SD): 0.09 ± 0.02 g (SD)
- Feeding during test: no

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
about 210 mg/L expressed as CaCO3
Test temperature:
24.5°C - 25.3°C over time period from 0 to 96 h
pH:
7.3 - 8.2 over time period from 0 to 96 h
Dissolved oxygen:
7.1 - 8.2 mg/L over time period from 0 to 96 h
Nominal and measured concentrations:
1000 and 10000 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass beakers
- Material, size, headspace, fill volume: glass, 2000 mL
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): not replaced
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dilution water was DSWL, prepared by addition of several salts to groundwater from a locality near Linschoten (the Netherlands)
- Total organic carbon: 1.7 mg/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: at start and every 24 h

OTHER TEST CONDITIONS
- Adjustment of pH: equilibrium pH of medium should be 8.3 - 8.5, but was slightly less, namely 8.0 - 8.2
- Photoperiod: 16 h light - 8 h dark regime


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Sampling method: dead animals were counted and removed at least after 24 h, 48 h, 72 h and 96 h. Swimming behaviour, colour, respiratory function and any other morphological or visually behavioural criterion was observed and compared to control animals

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test
- Justification for using less concentrations than requested by guideline: Limit test
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
other: saturated solution
Basis for effect:
mortality (fish)
Details on results:
In the case of Aerosil 200, LC50 values could not be calculated because there is no adverse effects observed with regard to survival

Applicant's summary and conclusion