Sulfuric acid, mono-C16-20-alkyl esters, sodium salts

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

25 - 27 Nov 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The test has been conducted in 1974 following a company internal test guideline. The test is set up as a screening test for the evaluation of the non-hazardous concentration of chemicals for aquatic organisms. The test principle is to expose fish (L. idius) to increasing concentrations of a test substance and determine the highest concentration at which none of the fish show signs of toxicity, i.e. where no mortality is observed. 1100 mg/L of product (purity 24.5%) equal to 270 mg/L active ingredient was chosen as the highest test substance concentration, and 3 different lower concentrations were tested. This test design resulted in 440 mg/L of product (108 mg a.i./L) as the lowest tested concentration. No mortalities were observed at any of the test concentrations. Therefore, it can be concluded that the test substance in not acutely toxic to fish at concentrations below 270 mg a.i./L. Taking into account that this test is not regarded as a standard OECD 203, but as a tox limit screening test, a Klimisch grade 2 is justifiable.

Justification for type of information:

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

Qualifier:

according to guideline

Guideline:

other: DIN 38412 - L15 "German standard methods for the examination of water, waste water and sludge; bio-assays (group L); determination of the effect of substances in water on fish, fish-test"

Deviations:

yes

Remarks:

no control was conducted

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: golden orfes
- Feeding during test: none
- Pretreatment: none

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

ca. 93 mg Ca and 12 mg Mg / L

Test temperature:

19.7 - 20.8 °C

Nominal and measured concentrations:

440, 660, 880, 1100 mg product/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: fish basins containing 10 L test water
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1


TEST MEDIUM / WATER PARAMETERS
copper and chlorine free drinking water

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 0, 6, 24 and 48h

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 1 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 270 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Dose descriptor:

LC100

Effect conc.:

> 270 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

No mortality was observed at any of the test concentrations.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

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

Qualifier:

according to guideline

Guideline:

other: Fish-Pesticide Acute Toxicity Test Method

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Fish Bioassay Procedure, Standard Methods (USPHA), 1970

Deviations:

yes

Remarks:

but no details available

GLP compliance:

no

Remarks:

pre-dates GLPs

Analytical monitoring:

no

Details on sampling:

100 mL samples of test solution were removed for analysis from each of three concentrations at 0, 4, 8, 24, 48 and 96 h and preserved with formaldehyde. The preserved samples were sent to the sponsor for analysis, but those results are not available in this study report.

Vehicle:

no

Details on test solutions:

TEST SOLUTION PREPERATION: Due to insolubility of test material, at concentrations tested, in either water or ethylene glycol, appropriate amounts of dry test material were weighed out and added directly to the test diluent. The test solutions were mixed to suspend the test chemical, but it quickly settled out on the bottom in all concentrations tested.

Test organisms (species):

Lepomis auritus

Details on test organisms:

TEST ORGANISM
- Common name: Blue gill
- Strain: Not reported
- Source: Commercial fish hatchery in Wisconsin
- Test fish were observed in lab facilities for at least 10 days prior to testing. During that period, mortality was <1%, and the fish were judged to be in excellent physical condition.
- Age at study initiation: Not reported
- Length at study initiation: 37 ±4 mm
- Weight at study initiation: 0.6 ±0.2 g
- Method of breeding: Not reported
- Feeding during test Not reported
ACCLIMATION
- Acclimation period: 24 h
- Acclimation conditions: Same as test conditions.
- Type and amount of food: Not reported
- Feeding frequency: Not reported
- Health during acclimation: Not reported

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

35 mg/L as CaCO3

Test temperature:

18 ± 0.5 °C

pH:

7.1
The reconstituted water had a pH of 7.1. pH of test solutions during the test are not available in the study report.

Nominal and measured concentrations:

Not reported

Details on test conditions:

TEST SYSTEM
- Type: Open
- Material: 5-gallon glass vessels containing 15 L test solution
- Aeration: No
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: Not reported
- Biomass loading rate: 15 L/6 g fish =>2 L/g fish

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: The dilution water was reconstituted water. The reconstituted water contained 3 mg/L potassium chloride, 30 mg/L calcium sulfate, 30 mg/L magnesium sulfate, and 40 mg/L sodium bicarbonate.
- Alkalinity: 35 ppm

CHEMICAL ANALYSIS OF DILUTION WATER:
- pH: 7.1
- methyl orange alkalinity: 35 ppm

EFFECT PARAMETERS MEASURED: Mortality. In addition, fish from the highest test concentration exhibiting no mortality after 96 h exposure were transferred to clean water for a period of 48 h. Specimens were then sacrificed and wet mounts of gill tissues were prepared for microscopic examination.

TEST CONCENTRATIONS: Not specified.

RANGE FINDING STUDY: No

Reference substance (positive control):

yes

Remarks:

p,p'-DDT

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

76 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 50-116 mg/L

Details on results:

- 24 h and 48 h LC50 value: 78 mg/L (95% confidence limits: 52-118 mg/L)
- Other observations: Microscopic examination of wet mounted gills revealed that fish exposed to the highest test concentration (without mortality) appeared normal and functional. Concentration sampled for gill damage was 42 mg/L.
- Effect concentrations exceeding solubility of substance in test medium: Yes. Test material settled on the bottom in all test concentrations.

Results with reference substance (positive control):

96 h LC50: 0.002 mg/L DDT

Reported statistics and error estimates:

The LC50, and its 95% confidence interval, was based on conversion of the concentrations tested and the corresponding observed percent mortalities to logs and probits respectively, and the subsequent mathematical calculation of a linear regression equation

Validity criteria fulfilled:

not specified

Conclusions:

The 96 h LC50 of Tallow alkyl sulfate (TAS) to bluegill fish (Lepomis macrochirus) was 76 mg/L, based on nominal test concentration.

Executive summary:

The 96 h LC50 of Tallow alkyl sulfate (TAS) to bluegill fish (Lepomis macrochirus) was determined under static conditions, following the procedures described in the Fish-Pesticide Acute Toxicity Test Method of the USDA.

Mortality and gill damage were assessed. Fish from the highest test concentration exhibiting no mortality after 96 h exposure (42 mg/L) were transferred to clean water for a period of 48 h. Gill tissues were then examined microscopically.

Microscopic examination of wet mounted gills revealed that fish exposed to 42 mg/L test concentration appeared normal and functional.

The 96 h LC50 of TAS to bluegill fish (Lepomis macrochirus) was 76 mg/L. The result is based on nominal concentration.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Nov - 21 Nov 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The test has been conducted in 1986 following a company internal test guideline. The test is set up as a screening test for the evaluation of the non-hazardous concentration of chemicals for aquatic organisms. The test principle is to expose fish (B. rerio) to increasing concentrations of a test substance and determine the highest concentration at which none of the fish show signs of toxicity, i.e. where no mortality is observed. 22 mg/L of product (purity 55%) equal to 12 mg/L active ingredient was chosen as the highest test substance concentration, and 7 different lower concentrations were tested. This test design resulted in 1.5 mg/L (a.i.) as the lowest tested concentration. As the results clearly show, the concentrations below 4.4 mg/L (a.i.) did not cause any fish mortality. Therefore, it can be concluded that C16-18 alkyl sulfate, Na salt in not acutely toxic to fish at concentrations below 4.4 mg/L (a.i.). Although no blank (without test substance) has been included in the test, the test with 1.5 mg/L (a.i.) can be regarded as internal control that the animals in the test were healthy. Taking into account that this test is not regarded as a standard OECD 203, but as a tox limit screening test, a Klimisch grade 2 is justifiable.

Justification for type of information:

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

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

Deviations:

yes

Remarks:

No control was conducted.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION: Stock solution contained 10 g of the test substance per liter. Appropriate aliquotes were pipetted into the test vessels and filled up to the final volumes of 5 L.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish

ACCLIMATION
- Health during acclimation: mortality below 0.1%

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

none

Hardness:

approx. 250 mg CaCO3/L

Test temperature:

approx. 23 °C

pH:

7.6 - 7.8

Dissolved oxygen:

74 - 92%

Nominal and measured concentrations:

2.8, 4.0, 5.6, 8.0, 11, 16 and 22 mg product/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L fish basins containing 5 L test solution
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10

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

EFFECT PARAMETERS MEASURED: mortality and sublethal effects after 0, 6, 24, 48, 72 and 96 h

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

4.4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

5.2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

6 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Reference 4

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

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Vehicle:

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

5.2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: read-across from CAS 68955-20-4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

76 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: read-across from CAS 68140-10-3

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 270 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: read-across from CAS 1120-04-3

Description of key information

96h LC50 (Danio rerio) = 5.2 mg/L (nominal concentration, ISO 7346-1, read-across)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

5.2 mg/L

Additional information

Since no reliable short-term toxicity tests with fish is available for C16-20AS Na (CAS 91648-55-4), in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to other structurally related substances was conducted. Read-across data available for C16-18AS Na (CAS 68955-20-4), C18AS Na tallow (CAS 68140-10-3) and C18AS Na (CAS 1120-04-3) were used considering animal welfare. Toxicity of alkyls sulfates is dependent on the carbon chain length. Homologues of C-chain length of C13 to C15 are considered as the most toxic from the whole Alkyl Sulfate Category. Toxicity of the chains from C16 and higher will decrease due to lower bioavailability as a consequence of reduced water solubility.

One reliable short-term tests with fish are available for C16-18AS Na (CAS 68955-20-4). The key, non-GLP study was performed according to ISO 7346-1 guideline (BASF 2001a). Zebrafish (Danio rerio) were exposed under semi-static conditions for 96 hours to seven test concentrations up to 22 mg/L of the 55% pure product. No analytical measurements are available. The results show that the 96-hour LC50 value was 5.2 mg a.i./L (nominal concentration).

A non-GLP study is available for C18AS Na tallow (CAS 68140-10-3). P&G study (1970) reports a short-term toxicity test with blue gill performed according to Fish Bioassay Procedure, Standard Methods (USPHA), 1970. Fish were exposed for 96 hours to the test substance under static conditions; no analytical check of the test concentrations is available. The LC50 value after 96 hours was determined as 76 mg/L (nominal concentrations).

Finally, one non-GLP study is available for C18AS Na (CAS 1120-04-3, BASF 2001b). The test was performed according to DIN 38412/15 Method with golden orfes (L. idus). The fish were exposed under static conditions to 4 test concentrations up to 1100 mg/L as product (270 mg/L as a.i.). The 48-h LC50 values was higher than 270 mg a/i./L.

Due to structural and property similarities with the tested category member it can be concluded that the above results apply also to C16-20AS Na (CAS 91648-55-4). The worst case 96-hour LC50 value for fish is 5.2 mg/L.