4-poly(propyl), benzene sulfonic acid

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:

18 October 2007 to 21 December 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Deviations:

yes

Principles of method if other than guideline:

Some of the test vessels at 24 hours (old media) during the defintive test showed Air Saturation Vale below the 60% stated in the protocol. This deviation was considered not to have affected the outcome of the integrity of the study as ASV values for the remainder of the test were above 60% and the fish showed no sub-lethal affects or mortality over the test period.

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Sponsor's identification: AS305BD
Description: dark brown, viscous liquid
Lot number: TS07002
Analytical purity: 100%
Storage conditions: room temperature in the dark

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

A Strata C8 (500 mg/3 mL) solid phase extraction (SPE) cartridge was sequentially preconditioned with methanol and water·. A volume (500 mL) of test sample was eluted through the cartridge and the cartridge dried. The test material was eluted from the cartridge with methanol (10 mL). Standard solutions were prepared in methanol at a nominal concentration of 5 mg/L.

Water samples were taken from the control and each replicate test vessel at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) for quantitative analysis. Duplicate samples and samples at 24 (fresh media), 48 (fresh and old media) and 72 (old media) were taken and stored at approximately -20°C for further analysis if necessary.

Test solutions

Vehicle:

no

Details on test solutions:

An amount of test material (2250 mg) was dispersed in 22.5 Iitres of dechlorinated tap water with the aid of propeller stirring at approximately 1500 rpm at a temperature of approximately 14°C for a period of 24 hours. After 24 hours the stirring was stopped and the undissolved test material removed by filtration (0.2 µm Sartopore filter, first approximate 1 litre discarded in order to precondition the filter) to give the 100% v/v saturated solution. This method of preparation was conducted in triplicate to give replicates R1, R2 and R3.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Brow Well Fisheries Limited, Hebden , Yorkshire, UK
- Age at study initiation (mean and range, SD): not stated
- Length at study initiation (length definition, mean, range and SD): not stated
- Weight at study initiation (mean and range, SD): not stated
- Feeding during test: none

ACCLIMATION
- Acclimation period: 3 December 2007 to 17 December 2007
- Acclimation conditions (same as test or not): yes
- Type and amount of food: commercial trout pellets
- Feeding frequency: not stated
- Health during acclimation (any mortality observed): none

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

None

Test conditions

Hardness:

approximately 140 mg/L as CaC03

Test temperature:

14°C to 16°C

pH:

7.6-8.1

Dissolved oxygen:

5.6-11.0 mg O2/L

Salinity:

Not stated

Nominal and measured concentrations:

Following a range-finding tests, a 'limit test' was conducted at a concentration of 100% v/v saturated solution.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): covered to reduce evaporation
- Material, size, headspace, fill volume: 20 litre glass vessels
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: 1.08g bodyweight/litre


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated laboratory tap water
- Total organic carbon: 4.53 mg C/L
- Alkalinity: 130 mg/l as CaCO3
- Conductivity: 459 µS/cm

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light/8 hours dark
- Light intensity: not stated

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 other: % v/v

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 other: % v/v

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

mortality (fish)

Details on results:

The results of the definitive test showed the highest test concentration resulting in 0% mortality to be greater than or equal to 100% v/v saturated solution, the lowest test concentration resulting in 100% mortality to be greater than 100% v/v saturated solution and the No Observed Effect Concentration (NOEC) to be 100% v/v saturated solution. The No Observed Effect Concentration is based upon zero mortalities and the absence of any sub-lethal effects of exposure at this concentration.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Estimated LC50 value is based upon inspection of the mortality data.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1. Cummulative mortality data in the range-finding test.

Nominal Concentration (% v/v saturated solution)	Cumulative mortality (initial population =3)
	3 hours	6 hours	24 hours	48 hours	72 hours	96 hours
Control	0	0	0	0	0	0
100	0	0	0	0	0	0

Table 2. Cumulative mortality data in the definitive test.

Nominal Concentration (% v/v saturated solution)	Cumulative mortality (initial population =3)						% Mortality
	3 hours	6 hours	24 hours	48 hours	72 hours	96 hours	96 hours
Control R1	0	0	0	0	0	0	0
Control R2	0	0	0	0	0	0	0
100 R1	0	0	0	0	0	0	0
100 R2	0	0	0	0	0	0	0
100 R3	0	0	0	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Validation criteria (as above) were fullfilled.

Conclusions:

The acute toxicity of the test material to freshwater rainbow trout has been investigated and gave a 96-hour LC50 of >100% v/v saturated solution. The corresponding NOEC was 100% v/v saturated solution.

Executive summary:

Introduction

A study was performed to assess the acute toxicity of the test material to rainbow trout (Oncorhynchus mykiss).The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC), US CFR Title 40 Part 797 Section 1400: US EPA Pesticide Assessment Guideline, Sub-Division E Section 72-1 and US EPA Draft Ecological Effects Test Guideline OPPTS 850.1075.

 

Methods.

Following a preliminary range-finding test, fish were exposed, in three groups of ten, to a saturated solution of the test material for a period of 96 hours at a temperature of 14°C to 16°C under semi-static test conditions. The test material solution was prepared by stirring an excess (100 mg/L) of test material via propeller stirrer in dechlorinated tap water at approximately 1500 rpm at a temperature of approximately 14°C for 24 hours prior to removing any undissolved test material by filtration (0.2µm Sartopore filter, first approximate 1 litre discarded in order to pre-condition the filter) to produce a saturated solution. The number of mortalities and any sublethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

 

Results.

The 96-Hour LC₅₀ based on nominal test concentrations was greater than 100% v/v saturated solution and correspondingly the No Observed Effect Concentration was 100% v/v saturated solution.

The chromatograms for the saturated solutions of the test material showed two sets of peaks, one set at approximately 4 to 6 minutes and one set at 8 to 12 minutes. The peaks at 8 to 12 minutes were consistent with the test material standard and were considered to be the test material AS305BD. It was considered, and agreed with the Sponsor, that the peaks at 4 to 6 minutes were consistent with those of AL305B a starting component in the production of the test material AS305BD. The test preparations were therefore analysed for both the notifiable material AS305BD and unreacted AL305B present.

Analysis of the test preparations at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) showed the measured concentrations for AS305BD to be less than the limit of quantitation of the analytical method with the exception of a single measured concentration of 0.0623 mg/L at 100% v/v saturated solution replicate R2 at 96 hours. This does not infer that no test material was in solution but that the dissolved concentration (i.e. bioavailable to the test organisms) was below the limit of quantitation which was assessed down to 0.019 mg/L. The measured concentration of AS305BD observed in 100% v/v saturated solution replicate R2 at 96 hours was considered to be possibly due to post-sampling contamination given that no test material was quantified in the corresponding freshly prepared test sample at 72 hours. This was considered to have no effect on the overall results as no mortalities or sub-lethal effects of exposure were observed in this test replicate.

Analysis of the test preparations at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) showed the measured concentrations for AL305B to be less than the limit of quantitation of the analytical method. This does not infer that no test material was in solution but that the dissolved concentration (i.e. bioavailable to the test organisms) was below the limit of quantitation which was assessed down to 0.0045 mg/L.

This study showed that there were no toxic effects at saturation.