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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD Test Guideline 202 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
temperature marginally above guideline limits
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Montan wax
EC Number:
232-313-5
EC Name:
Montan wax
Cas Number:
8002-53-7
Molecular formula:
As montan wax is a UVCB, a molecular formular cannot be specified.
IUPAC Name:
Montan wax

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Details on test solutions:
As solubility lies below 100 mg/L, a saturated solution was prepared for the test. This was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 µm filters.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: Straus
- Source: Umweltbundesamt Berlin, Germany
- Age at study initiation (mean and range, SD): 0-24 hours
- Method of breeding: Daphnia magna is bred in the LAUS GmbH throughout the year.
- Feeding during test: no

Study design

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

Test conditions

Hardness:
2.5 mmol/l
Test temperature:
21.9 to 23.3 °C
pH:
7.6 to 8.8
Dissolved oxygen:
> 8.4 mg/L
Nominal and measured concentrations:
Because of the low water solubility of the test item, the measured values for treatment and control were in the same range. Therefore, the determination of the biological results was based on the nominal concentration.
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no

Results with reference substance (positive control):
- Results with reference substance valid? Yes
- EC50/LC50: 0.83 mg/L (24h)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In a study according to OECD test guideline 202 under GLP, the acute toxicity EC50 to Daphnia magna of the test substance was determined to be > 100 mg/L.
Executive summary:

In a study according OECD test guideline 202 under GLP, the limit test test substance containing of 100 mg/L was used (nominal concentration). Twenty daphnia were exposed to the test substance for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted. The treatment showed no toxicity. No animals were immobilised in the control.

The 24h-EC50i of potassium dichromate was tested in a current positive control test. The value was determined as 0.83 mg/L, lying within the demanded range of 0.6 — 1.7 mg/L.

At the beginning and at the end of the test, the content of test item was determined by calculation from content of organic carbon of the test item (80.4 %) and DOC-determination in the test solutions. Because of the low water solubility of the test item, the measured DOC values of treatment and control were in the same range.

Therefore the determination of the biological results was based on the nominal concentration.

The EC50 of the test substance was determined to be > 100 mg/L (nominal).