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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 Jan 2007 - 5 Jan 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 09898602
- Date received: 6 Nov 2006
- Expiration date of the lot/batch:> 6 months from recepit date at 25°C
- Purity: 99.8%
- Physical Appearance: yellow liquid
- Storage: refrigerated, 1-10°C
Analytical monitoring:
yes
Details on sampling:
- Limit of detection – 0.01 mg/L
- Samples for chemical analysis taken at 0 hours (freshly prepared) and at 48 hours (old test media).
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A stock medium at nominal concentration of 1000 mg/L was prepared by adding the test item directly to daphnia medium (ASTM). Following pre-treatment (ultra-sound and stirring over night), the test media were prepared by diluting aliquots of the 1000 mg/L stock medium with ASTM to achieve the required nominal concentrations.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain/clone: Straus
- Age at study initiation: less than 24 hours old
- Source: The Environmental Agency, Portsmouth, UK
- Age of parental stock: 29 days
- Feeding during test : Daphnia was not fed
Test type:
static
Water media type:
other: ASTM water
Limit test:
no
Total exposure duration:
48 h
Hardness:
95 mg/L
Test temperature:
19.0 - 19.9 °C
pH:
7.3 - 7.6
Dissolved oxygen:
90 - 105
Nominal and measured concentrations:
Range finder test (nominal) mg/L): 0, 0.1, 1.0, 100, 100.0 and 1000
Definitive test (nominal) (mg/L): 0, 7.81, 15.6, 31.3, 62.5, 125.0, 250.0, 500 and 1000
Definitive test (measured) (mg/L): 0, 7.54, 15.4, 30.3, 61.3, 122.0, 242.0, 487.0 and 983.0
Details on test conditions:
TEST SYSTEM
- Test vessel: 150 mL glass crystallising dishes, containing 125 mL of the test media
- Type: closed
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates):
- No. of vessels per vehicle control (replicates):
- Biomass loading rate:


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hor light and 8-hour dark

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
62.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
151 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
ca. 244 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
ca. 62.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
The lowest concentration causing 100% immobilisation was 1000mg/L.
Results with reference substance (positive control):
N/A
Reported statistics and error estimates:
Toxicity values were calculated using probit method of analysis (Stephen et al 1987).
Validity criteria fulfilled:
yes
Conclusions:
The test item was found to be toxic to Daphnia magna under the conditions. It was concluded that the 48-hour EC50 and NOEC in Daphnia Magna were 151 and 62.5 mg/L, respectively.
Executive summary:

Introduction


The objective of the study was to determine the 24 and 48-hour EC50 toxicity values for Medol-10 (known hereafter as Subject Chemical) exposure to Daphnia magna.


Results


The overall mean measured concentrations of the Subject Chemical were 7.54, 15.4, 30.3, 61.3, 122, 242, 487 and 983 mg/L, corresponding to 97, 99, 97, 98, 98, 97, 97 and 98 % of the nominal concentrations, respectively. 


Conclusion


The test item was found to be toxic to Daphnia magna under the conditions. It was concluded that the 48-hour EC50 and NOEC in Daphnia Magna were 151 and 62.5 mg/L, respectively.

Description of key information

48 hour toxicity study:

EC50(immobilisation): 151 mg/L 

NOEC (immobilisation): 62.5 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
151 mg/L

Additional information

A determination of the acute toxicity to aquatic invertebrates of MEDOL-10 was conducted (Covance Laboratories Ltd, 2007, Study 2777/005-D2149). The study was performed in accordance with the EPA test guideline OPPTS 850.1010, and in compliance with GLP.

 

Following a preliminary range-finding test, 20 less than 24 hours old Daphnia magna (4 replicates of 5 animals) were exposed to aqueous solutions of MEDOL-10 at nominal concentrations of 7.81, 15.6, 31.3, 62.5, 125, 250, 500 and 1000 mg/Lin ASTM medium for 48 hours at a temperature of 20 °C under static test conditions.

 

Analysis of the fresh and old test preparations showed the measured concentrations to be within the range of 80 – 120 % ; hence, the results are expressed in terms of nominal concentrations.

 

The test item was found to be toxic to Daphnia magna under the conditions. The highest concentration at which no immobilisation occurred was 62.5 mg/L at 48-hours, whereas the lowest concentration at which 100% immobilisation occurred was 1000 mg/L. It was concluded that the 48-hour EC50 and NOEC in Daphnia Magna were 151 and 62.5 mg/L, respectively.