Sulfuric acid, mono-C12-14(even numbered)-alkyl esters, ammonium salts

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

12 Feb - 16 Feb 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

Department of Health of the Government of the United Kingdom, D.F. moore, 27th February 1996

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 1 g test materail was dispersed in dechlorinated tap water with the aid of ultrasonic disruption and the volume was adjusted to 1 L to give a 1 mg/L stock solution. Aliquots of this stock solution (20, 36, 64, 112 and 200 mL) were each separately dispersed in 20 L (final volume) of dechlorinated tap water to give the test series of 1.0, 1.8, 3.2, 5.6 and 10 mg/L, respectively.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Donnington Fish Farm, Upper Swell, Gloucestershire, UK
- Age at study initiation (mean and range, SD): juveniles
- Length at study initiation (length definition, mean, range and SD): 4.7 cm ± 0.1 cm
- Weight at study initiation (mean and range, SD): 1.18 g ± 0.2 g
- Bioloading: 0.59 g bodyweight/L
- Feeding during test: non

ACCLIMATION
- Acclimation period: one week
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: commercial trout pellets
- Feeding frequency: Daily until 1 day prior to testing
- Health during acclimation (any mortality observed): mortality <1% in the seven days prior to the test

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

100 mg/L as CaCO3

Test temperature:

14°C

pH:

7.4 - 7.8

Dissolved oxygen:

9.4 - 10.1 mg O2/L

Salinity:

Conductivity: 382 µS/cm

Nominal and measured concentrations:

Nominal: 0, 1.0, 1.8, 3.2, 5.6 and 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 L glass vessels, covered to reduce evaporation
- Aeration: yes via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): daily as semi-static test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water dechlorinated by passage through an activated carbon filter
- Alkalinity: 80 mg/L
- Ca/mg ratio: 43 mg/L : 7 mg/L
- Conductivity: 382 µS/cm

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, behaviour anormalities

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 0, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no mortality at 1 mg/L, 100% mortality after 24 hours at test concentrations 10 and 100 mg/L

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% C.L: 3.0-4.2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: after exposure to 3.2 mg/L the sypmtom "swimming at the bottom" was observed after 72 h of exposure for some of the fish, after exposure to 5.6 mg/L some fish loss equilibrium after 6 hours of exposure. Fish exposed to 10 m/L were moribund after 3 hours of exposure

Reported statistics and error estimates:

The LC50-values and associated confidence limits were calculated by the moving average method of Thompson (1947)

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

01 Jul - 12 Jul 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Donnington Fish Farm, Upper Swell, Gloucestershire, United Kingdom, in-house since 16 Apr 1996
- Age at study initiation: juvenile
- Length at study initiation: 4.4 ± 0.2 cm
- Weight at study initiation: 1.08 ± 0.17 g
- Feeding during test: feeding was stopped 48 hours prior to test.

ACCLIMATION
- Acclimation period: 01 Jul - 08 Jul 1996
- Acclimation conditions: no, fish were held in a glass fibre tank with a single pass water renewal system.
- Type and amount of food: commercial trout feed pellets
- Feeding frequency: daily
- Health during acclimation: approx. 1% mortality 7 days prior to test

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

not relevant

Hardness:

total hardness: approx. 100 mg CaCO3/L

Test temperature:

14 °C

pH:

7.6 - 8.1

Dissolved oxygen:

9.4 - 9.6 mg O2/L

Nominal and measured concentrations:

nominal: 0, 1.8, 3.2, 5.6, 10 and 18 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 L exposure vessels
- Type: closed
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.54 g b.w./L (static volume)


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechlorinated, passed through activated carbon filter
- Metals: all well under the PCV value
- Pesticides: total pesticides found (19 tested) < 0.04 µg/L
- Chlorine: total chlorine: 0.16 mg/L
- Alkalinity: 80 mg/L
- Ca/mg ratio: 43:7 (mg/L)
- Conductivity: 405 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: 24 hours

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light/ 8 hours dark

EFFECT PARAMETERS MEASURED: mortality and sublethal effects after 3, 6, 24, 48, 72 and 96h

TEST CONCENTRATIONS
- Range finding study: two range finding studies
- Test concentrations: In a first range finding study 1, 10 and 100 mg/L were tested leading to a first study conducted with 10, 18, 32, 56 and 100 mg/L. Since already in the lowest test concentration effects were observed which makes a NOEC derivation impossible, this test was cancelled and a second range finding study conducted. Here 1.8 and 18 mg/L were tested. Finally, the definite study was conducted with 1.8, 3.2, 5.6, 10 and 18 mg/L.
- Results used to determine the conditions for the definitive study: no mortalities at 10 mg/L, 3 mortalities at 100 mg/L; at second study: 0 fish died at 1.8 mg/L, all 3 fish died at 18 mg/L.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3.6 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: Fish were swimming at the bottom of exposure vessel at 10 mg/L and 18 mg/L.
- Mortality of control: none

Reported statistics and error estimates:

LC50 values were calculated by moving average method of Thompson (1947).

Sublethal observations / clinical signs:

Table 1: Cumulative number and % of dead fish

Concentration [mg /L]	Incubation time (in h)							mortality [%]
	0	3	6	24	48	72	96	96 h
control	0	0	0	0	0	0	0	0
1.8	0	0	0	0	0	0	0	0
3.2	0	0	0	0	0	0	0	0
5.6	0	0	0	0	0	0	0	0
10	0	0	0	0	2	5	7	70
18	0	0	10	10	10	10	10	100

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% C.L: 3.0-4.2

Remarks:

Source, key, 85586-07-8, 1996

Description of key information

96h LC50 (Oncorhynchus mykiss) = 3.6 mg/L (nominal concentration, OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

3.6 mg/L

Additional information

Since no reliable acute fish test is available for C12-14AS NH4 (CAS 90583-11-2), in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5, a read-across to other structurally related category members was conducted. Read-across data from the following substances were used: two C12-14 mixtures: C12-14AS TEA (CAS 90583-18-9) and C12-14AS Na (CAS 85586-07-8). Toxicity of alkyl sulfates is dependent of the carbon chain length and the influence of the counter ion can be neglected.

The key, GLP study (Wetton 1996a) was conducted with C12-14AS Na (CAS 85586-07-8) according to OECD 203 under semi-static conditions on rainbow trouts (Oncorhynchus mykiss). The fish were exposed to the test concentrations up to 10 mg/L (nominal) for 96 hours. Analytical monitoring was not performed. The reported LC50-value was 3.6 mg/L (nominal concentration).

Another study is available for C12-14AS TEA (CAS 90583-18-9). The GLP-compliant test was performed in semi-static conditions with rainbow trout (Oncorhynchus mykiss) according to OECD 203 (Wetton 1996b). Mortality of fish caused by the test substance was determined after 24, 48, 72 and 96 hours of exposure to the concentrations up to 18 mg/L of 40% pure technical product (in water) corresponding to 7.2 mg a.i./L. No analytical measurements of test concentrations are available. The results showed that the 96-hour LC50 value was 3.6 mg a.i./L (nominal concentration).

The composition of carbon chains of the tested category members C12-14AS Na (CAS 85586-07-8) and C12-14AS TEA (CAS 90583-18-9) are the same as of C12-14AS NH4 (CAS 90583-11-2): on average 65% of C12 and 35% of C14 chains. Due to structural and property similarity with the tested category member, the LC50 value of 3.6 mg/L is considered to be reliable also for C12-14AS NH4 (CAS 90583-11-2).