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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
2-chloro-5-methoxybenzene-1-sulfonamide
Cas Number:
502187-53-3
Molecular formula:
C7H8ClNO3S
IUPAC Name:
2-chloro-5-methoxybenzene-1-sulfonamide
Specific details on test material used for the study:
Test substance: IN-F4106-009
Lot number: CCS-1213/STG-01/00112 BL
Purity: 97.2%

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Remarks:
ISO medium

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Water media type:
other: ISO medium
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
250 mg/L as CaCO3
Test temperature:
20 - 21°C
pH:
7.8
Dissolved oxygen:
7.8 to 8.0 mg/L
Salinity:
Alkalinity: 0.8 mmol/L
Nominal and measured concentrations:
Nominal: 10 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate (tested at least twice a year)

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
In the most recent test with the reference item potassium dichromate the EC50 after 24 hours was determined to be 0.862 mg test item/L indicating that the sensitivity of the Daphnia was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
48-hour EC50 (Daphnia magna): >10 mg/L, 48-hour NOEC (Daphnia magna): ≥10 mg/L and the 48-hour LOEC (Daphnia magna): >10 mg/L.
Executive summary:

The objective of this test was to determine the acute effects of the test item on the cladoceran Daphnia magna. Young Daphnia (<24 hours old) were exposed in a static test to the test item for 48 hours, added to test water containing the test item at the concentration of nominal 10 mg/L. This limit test was performed in compliance with the test guidelines to demonstrate that the test item has no toxic effect on daphnids up to at least this concentration. It was selected in consultation with the Sponsor and was based on the results of exploratory range finding toxicity data.


The test method of application and the test species Daphnia magna are recommended by the OECD Guideline 202.


The purpose of the analytical part of this study is to verify the concentrations of the test item in the test medium.


The effect of IN-F4106 on the mobility of Daphnia magna was determined in ISO medium (prepared according to OECD guideline 202). Four replicates with 5 test animals each at one nominal test concentration of 10 mg/L, and a test water control were incubated in a controlled room environment for 48 hours at 20 - 21 °C and the mobility of the Daphnia was determined daily.


The test item was determined by reversed phase high performance liquid chromatography with UV-detection (HPLC-UV).


The toxic effect of the test item to Daphnia magna was determined in a static limit test. The 48-hour EC50 value was calculated to be higher than 10 mg/L. The 48-hour NOEC was higher than or equal to 10 mg/L and the 48-hour LOEC was higher than 10 mg/L.