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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: There were no circumstances that may have affected the quality or integrity of the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2007-01-12

Test material

Constituent 1
Reference substance name:
Montanov 82
IUPAC Name:
Montanov 82
Details on test material:
- Batch n°: T62935
- Appearence: pearls of wax
- Purity: ES>99%
- Stability: water 96 h
- Solubility: water<0.1g/L
- Production date 2006/07/20
- Expiry date 2008/01/19
- Storage: room temperature 20 +/-5°C

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
As solubility lies below 100mg/L, the water-accomodated fraction 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 0.45um filters.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
- Variety: STRAUSS
- Strain: Berlin
- Sex: female
- Age: between 0 and 24 hours
- Origin: Umweltbundesamt Berlin
- Arrival of Strain: October 4th 2005
- Food: unicellular green algae (Desmodesmus subspicatus)

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
21.9-22.5°C
pH:
7.7-7.9
Dissolved oxygen:
8.3mg/L
Nominal and measured concentrations:
0 / 1 / 10 / 100 mg/L
Details on test conditions:
The water accomodated fraction was prepared by weighing of the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 um filters.
Vessels: glass beakers

-Main study and reference study:
Replicates: four vessels, each containing 20 mL test solution and five daphnia
Control: four vessels, each containing 20 mL dilution water and five daphnia
Mediumrenewal: twice a week
Photo period: 16/8 hours, using neon tubes
Reference substance (positive control):
yes
Remarks:
K2Cr2O7

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
immobilisation in the control was 10% at the most
the lowest concentration of dissolved oxygen at the end of the test was 8.3 mg/L
the highest variation of the pH value in the test solutions was 0.2 units
Results with reference substance (positive control):
24h-EC50i was determined as 1.4 mg/L (lying within the range demanded of 0.6 - 2.1 mg/L)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Duration Endpoint Effect conc.
24 h NOEC ca. 100 mg/L
24 h EC50 > 100 mg/L
24 h EC100 > 100 mg/L
48 h NOEC ca. 100 mg/L
48 h EC50 > 100 mg/L
48 h EC100 > 100 mg/L
Executive summary:

This study was performed in order to evaluate the toxic potential of Montanov 82 towards freshwater shrimp, using the species Daphnia magna. D. magna STRAUSS, which belongs to the family of crustacea, was chosen in the guideline as a typical part of zoo-plancton.

This study was conduced in accordance of the following guidelines:

OECD guideline for testing of chemicals nµ° 202, adopted April 13th 2004.

EU-guideline C.2. "acute toxicity for Daphnia" adopted July 31st 1992.

This study was conduced in compliance with the GLP.

As solubility lies below 100mg/L, the water-accomodated fraction 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 0.45um filters.

In the main study, three concentrations of the test item in a geometric series (spaced by factor 10, the highest being 100mg/L) were used. Twenty Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.

No significant immobilisation was observed in the treatments and in the control.

The 24h-EC50i of potassium dichromate was tested in a current reference test. The value was determined as 1.4 mg/L, lying within the demanded range of 0.6 -2.1 mg/L.

The following results could be determined for the test item Montanov 82 (species: Daphnia magna)

24 h NOEC = 100 mg/L

24 h EC50i > 100 mg/L

48 h NOEC = 100 mg/L

48 h EC50i > 100 mg/L