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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013-12-16 until 2014-01-15
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all (At the end of the exposure period, the replicates were pooled at each concentration before sampling.)
- Sampling frequency: at t=0h and t=48h
- Sample volume: 2.0 mL
- Sample storage conditions before analysis: stored in a freezer until analysis (<= -15°C)
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
Preparation of test solutions started with a nominal concentration of 100 mg/l for the combined limit/range-finding test and a nominal concentration of 10 mg/l for the final test. Fifteen to twenty minutes of magnetic stirring was applied to accelerate the dissolving of the test substance in the test medium. The lower test concentrations were prepared by subsequent dilutions of the 10 and 100 mg/l concentrations in test medium. Test solutions up to and including 1.0 mg/l were clear and colourless, while higher test concentrations were increasingly hazy with increasing concentration.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: Daphnia magna Straus
- Source: WIL Research Europe B.V., In-house laboratory culture
- Age at study initiation: < 24 h
- Method of breeding: acyclic parthenogenesis
- Feeding during test: no

BREEDING
- Maximum age of the cultures: 4 weeks
- Breeding conditions: M7 medium, 18-22°C
- Renewal of cultures: after 7 days of cultivation half of the medium twice a week
- Type of food: suspension of freshwater algae
- Feeding frequency: daily
- Validity of batch: immobilisation < 20%; no presence of males, ephippia or discoloured animals; no delay in first brood

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
180 mg CaCO3/L (Elendt M7 medium)
Test temperature:
19.1 - 19.6°C
pH:
7.8 - 8.2
Dissolved oxygen:
9.3 - 9.5 mg/L
Nominal and measured concentrations:
Actual test concentrations were in agreement with nominal (108-117%). The lowest test concentration slightly decreased to 79% of initial at the end of the test but was still in agreement with nominal (86%). All higher test concentrations remained stable (92-98% of nominal). Given these results, the EC50 was based on the nominal test concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL, all-glass, containing 80 mL of test solution
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 5 per vessel
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not applicable

TEST MEDIUM / WATER PARAMETERS
- Medium: Adjusted ISO medium
- Source/preparation of dilution water: tap water purified by Reverse Osmosis (ROwater, GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
- Culture medium different from test medium: yes (Elendt M7 medium)
- Intervals of water quality measurement: at 0 hours and at 48 hours

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours
- Light intensity: 271 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Immobility: at 24 hours and at 48 hours

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: not applicable
- Test concentrations range-finding test [mg/L]: 0.1, 1.0, 10, 100
- Test concentrations main test [mg/L]: 0.10, 0.18, 0.32, 0.56 and 1.0 mg/l
- Results used to determine the conditions for the definitive study: 100% immobilisation at 1 mg/L, 0% immobililisation at 0.1 mg/L
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.26 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL 0.24-0.28 mg/L
Details on results:
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Reported statistics and error estimates:
Parameters of the probit analysis at 48h
--------------------------------------------
Computation runs: 4.0000
Slope b: 14.9147
Intercept a: 8.3118
Variance of b: 5.2737
Goodness of Fit
Chi²: 0.4521
Degrees of freedom: 3.0000
p(Chi²): 0.9293
Log EC50: -0.58186
SE Log EC50: 0.0169
g-Criterion: 0.0911
F: 279.9170
p(F) (df: 1;3): 0.0000

Observations range-finding test:

All daphnids exposed to nominal concentrations of 1.0 mg/l and higher were immobilised after 24 hours of exposure. No immobility was observed at the lowest test concentration of 0.10 mg/l and the control during the test period. The expected EC50 was between nominal concentrations of 0.10 and 1.0 mg/l.

Validity criteria fulfilled:
yes
Conclusions:
The 48h-EC50 was 0.26 mg/l (95% confidence interval between 0.24 and 0.28 mg/l).
Executive summary:

Acute Toxicity Study in Daphnia magna with Benzenesulfonic acid, 4-C15-C16-sec-alkyl derivs.

The study procedures described in this report were based on the OECD guideline No. 202, 2004. In addition, the procedures were designed to meet the test methods of the Commission Regulation (EC) No 440/2008, Part C.2, 2008 and the ISO International Standard 6341, 1996.

The batch of Benzenesulfonic acid, mono, 4-C15-C16-sec-alkyl derivs. tested was a dark brown viscous liquid with a purity of 89.2% and completely soluble in test medium at the concentrations tested.

A final test was performed based on the results of a preceding combined limit/range-finding test. Preparation of test solutions started with a nominal concentration of 10 mg/l. Fifteen to twenty minutes of magnetic stirring was applied to accelerate the dissolving of the test substance in the test medium. The lower test concentrations were prepared by subsequent dilutions of the 10 mg/l concentration in test medium. Test solutions up to and including 1.0 mg/l were clear and colourless.

Twenty daphnids per concentration (four replicates, five daphnids per replicate) were exposed to a control and to nominal test concentrations of 0.10, 0.18, 0.32, 0.56 and 1.0 mg/l. The total exposure period was 48 hours and samples for analytical confirmation of actual exposure concentrations were taken at the start and at the end of the test.

Analysis of the samples taken at the start of the test showed that the actual test concentrations were in agreement with nominal (108-117%). The lowest test concentration slightly decreased to 79% of initial at the end of the test but was still in agreement with nominal (86%). All higher test concentrations remained stable (92-98% of nominal). Given these results, the EC50 was based on the nominal test concentrations.

The study met the acceptability criteria prescribed by the protocol and was considered valid.

The 48h-EC50 was 0.26 mg/l (95% confidence interval between 0.24 and 0.28 mg/l).

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP guideline study. No analytical verification of the test concentrations
Principles of method if other than guideline:
Method: other: Directive 79/831/EEC, Annex V, Part C
GLP compliance:
no
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
62.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
not neutralized
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
108.82 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
not neutralized
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
not neutralized

Mobile daphnids

Nominal conc.(mg/l)

Mobile daphnids after

0 h

3 h

6 h

24 h

48 h

0

20

20

20

20

20

3.9

20

20

20

20

20

7.8

20

20

20

20

20

15.6

20

20

20

20

20

31.2

20

20

20

20

20

62.5

20

20

20

20

20

125

20

20

20

20

6

250

20

20

20

0

0

500

20

1

0

0

0

pH values

Nominal conc.(mg/l)

pH values after

0 h

48 h

0

8.03

8.15

3.99

8.32

8.03

7.81

8.54

8.02

15.6

8.89

8.05

31.2

9.20

8.14

62.5

9.53

8.4

125

9.79

8.71

250

10.04

8.96

500

10.3

9.09

Conclusions:
The 48 h EC50 of MIPA to Daphnia magna was 108.82.

Description of key information

The short-term toxicity of Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs. was assessed in a static 48h acute study in Daphnia magna according to OECD guideline 202. The result of an 48h-EC50 of 0.26 mg/L (95% CL 0.24 -0.28 mg/L) can be considered reliable without restrictions.

For the second read across substance (MIPA), the 48 hr EC50 to Daphnia magna was 108.82 mg/L

As the short-term toxicity to invertebrate value for Benzenesulfonic acid, 4 -C15 -16 -sec-alkyl derivs. was significantly lower than that for MIPA, it will be used for Benzenesulfonic acid, 4 -C15 -16 -sec-alkyl derivs. MIPA-salt.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.26 mg/L

Additional information

The test concentrations were stable and within the acceptable range during the test. Therefore the estimated 48h-EC50 of 0.26 mg/L (95% CL 0.24 -0.28 mg/L) is based on the nominal test concentrations.