sodium 3-[(2,3-dicyanophenyl)thio]propane-1-sulfonate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Test phase 2013-08-12 to 2013-08-17.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Meets the criteria for classification as Reliable with restrictions according to Klimisch et al (1997). This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

See Confidential details on test material section

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method:
To demonstrate that nominal exposure concentrations were being achieved the concentrations of the test material in the test solutions were measured at 0 and 96 hours using high performance liquid chromatography.

At the start and at the end of the test, the control and exposure concentration were sampled.

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The exposure solution was prepared directly by weighing the required amount of test substance into a glass vial. The content of the vial was then added to the dilution water in the test tank which was stirred using a glass pipette. The control consisted of dilution water only. The final solutions were clear and colourless.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The rainbow trout O. mykiss used in this study (batch 45-13) were obtained from Houghton Springs Fish Farm, Winterbourne Houghton, Blandford Forum, Dorset, DT11 0PD on 19 March 2013 and held in 340 L fibreglass tanks under artificial lighting and were contained in water as described for the test dilution water. They were held at 15 C and were fed daily using a commercial fish food. Food was withheld from the fish for at least 24 hours prior to commencement of the test.

Following their arrival on site the fish were given a twice daily prophylactic treatment of formalin and malachite green twice daily. The treatment was completed on 28 March 2013 (>12 days before the start of the test) and the fish acclimated back to 100% freshwater. There were no mortalities recorded within 7 days prior of the start of the study.

The temperature of the dilution water in the holding tank was monitored daily.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

41.7 mg/L (CaCO3) total water hardness of dechlorinated water supply.

Test temperature:

14.8-15.7 C

pH:

7.4-7.87

Dissolved oxygen:

9.21-9.94 mg/L or 92-99% air saturation

Nominal and measured concentrations:

All analytical values are quoted to two significant figures and percentages to the nearest integer. At the start and end of the test the measured concentration of test material in the exposure concentration was 120 mg/L. The measured concentration of test material in the control was
The analysis of the triplicate samples taken from the 120 mg/L exposure concentration at the start of the study showed good consistency.

Based on the results of the analysis the nominal concentration was used for the reporting of results.

Details on test conditions:

TEST SYSTEM
The test employed a static design. The test was undertaken in a temperature controlled room which was set at the nominal test temperature of 15 C. The test solutions were gently aerated. The test vessels were glass tanks with a working volume of 40 L.

The photoperiod in this study was 16 hours light and 8 hours dark with 20 minute dawn and dusk transition periods.

At the start of the test ten fish were impartially allocated to each of the test exposure concentration and the control. The fish were not fed during the course of the test. At the end of the test the fish from the control were measured for length and wet weight.

TEST MEDIUM / WATER PARAMETERS
The dilution water was town’s water which had been coarsely filtered to remove particulate material, passed through activated carbon and dechlorinated using sodium thiosulphate. Salts were added, as required, to maintain minimum hardness levels, and the treated water passed through an ultraviolet steriliser and filtered to 10 µm. The supply was then delivered to a temperature controlled header tank in the test laboratory which was set to the nominal test temperature of 15 ± 1°C.

- Total organic carbon: <5 mg/L
- Particulate matter: suspended solids at 105 C <3 mg/L

- Metals:Metals reported as µg/L (sampled on 19/06/13)
Cd Hg Ag Al As Cr Co
<0.1 <0.01 <1 22.4 <1 <0.5 <1

Cu Fe Pb Mn Ni Zn B
<1 <30 <2 <10 <1 <5 <100


- Pesticides: Highest Organo-chlorine pesticides (ug/L) <0.01 Highest Organo-phosphorus pesticides (ug/L) <0.01
- Chlorine (as Cl2): Free <2 ug/L Total <2 ug/L
- Alkalinity as CaCO3: 25.8 mg/L
- Conductivity: 198.7 uS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement:
Schedule for water quality analysis of freshwater

Parameter Sampling frequency
pH Daily (Mon-Fri)
Conductivity Daily (Mon-Fri)
Alkalinity Once per week
Hardness Once per week
Free & Total Chlorine Once per week
Ammoniacal Nitrogen as N Quarterly
Suspended Solids Quarterly
Total Organic Carbon Quarterly
Chemical Oxygen Demand Quarterly
Anions/Cations and Metals Quarterly
Organo-chlorine Pesticides Quarterly
Organo-phosphorous Pesticides Quarterly
PCB Quarterly


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: The photoperiod in this study was 16 hours light and 8 hours dark with 20 minute dawn and dusk transition periods.


EFFECT PARAMETERS MEASURED : Observations for mortalities and symptoms of toxicity were made at 3, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Test concentration: 120 mg/L

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 6

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There were no mortalities during the study in either the exposure concentration or the control and no other symptoms of toxicity were observed.

At the end of the exposure period, the fish from the dilution water control were weighed and measured. The range in weight was 1.58 – 3.37 g with a mean of 2.31 g, and the range in length was 46 - 58 mm with a mean of 53 mm. The loading of fish in the dilution water control was approximately 0.58 g/L.

Any other information on results incl. tables

Sublethal observations / clinical signs:

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

There were no mortalities during the study in either the exposure concentration or the control and no other symptoms of toxicity were observed. Therefore, the 96 hour NOEC was determined to be 120 mg/L and the LOEC >120 mg/L. The results demonstrate that the LC50 for the (source) test material was greater than 120 mg/L at 24, 48, 72 and 96 hours.

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are considered sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

Executive summary:

Introduction

This study was undertaken to assess the acute toxicity of the (source) test material to rainbow trout, Oncorhynchus mykiss. The study was compatible with the following guidelines:

- OECD Guidelines for Testing of Chemicals. Test Guideline 203, Fish Acute Toxicity Test. Adopted 17 July 1992.

This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).

Results & Conclusions

There were no mortalities during the study in either the exposure concentration or the control and no other symptoms of toxicity were observed. Therefore, the 96 hour NOEC was determined to be 120 mg/L and the LOEC >120 mg/L. The results demonstrate that the LC50 for the (source) test material was greater than 120 mg/L at 24, 48, 72 and 96 hours.

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are considered sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.