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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 29 - May 6, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

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

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA-600/489/001: Short term methods for measuring the chronic toxicity of effluents and receiving waters to freshwater organisms. Deviations, reliability and validity evaluated against USEPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test).

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

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

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Samples were taken from all exposure concentrations on days 1, 4 and 7.
- Sampling method: 50 mL of sample water was removed from each of the replicate stream channels and combined to yield a 100 mL sample for each test concentration. Each sample was treated to three successive MBAS extractions using HPLC grade chloroform. Extracted material was combined and brought to 50 mL with fresh chloroform.
- Sample storage conditions before analysis: Not available

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test material stock solutions were prepared by diluting surfactants in distilled water. Stock mixtures of the test substance were made up in 4-L batches and placed on magnetic stirrers.
- Controls: in dilution water (no test substance)
- Evidence of undissolved material: slight precipitate

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

TEST ORGANISM
- Common name: Ceriodaphnia dubia
- Strain/clone: Not available
- Justification for species other than prescribed by test guideline: Not applicable
- Source: Virginia Polytechnic Institute and State University In-house breeding culture
- Age of parental stock: Not available
- Feeding during test: Yes
- Food type: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum
- Amount: Not available
- Frequency: daily at each renewal


ACCLIMATION
- Acclimation period: Not available
- Acclimation conditions (same as test or not): Not available
- Type and amount of food: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum
- Feeding frequency: Not available
- Health during acclimation (any mortality observed): Not available


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: not provided

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

7 d

Post exposure observation period:

Not applicable

Hardness:

Not available

Test temperature:

24.9 - 25.3 ºC

pH:

Not available

Dissolved oxygen:

Not available

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations were 0, 0.05, 0.10, 0.50, 1.0 and 2.0 mg/L
Measured concentrations were 0, 0.02, 0.08, 0.20, 0.80, 1.29 mg/L
The measured concentrations were 40, 80, 40, 80 and 65 % of the nominal concentrations, respectively. Results are based on measured concentrations.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: open
- Material: Test chamber is a 35 mL disposable polystyrene cup fitted with 120-µM Nitex mesh on opposite sides
- Aeration: no (test was flow-through)
- Type of flow-through: peristaltic
- Renewal rate of test solution (frequency/flow rate): 360 mL/h
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 1 daphnid/35 mL


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water as described by Lauth et al (1990)
- Total organic carbon: Not available
- Particulate matter: Not available
- Metals: Not available
- Pesticides: Not available
- Chlorine: Not available
- Alkalinity: Not available
- Ca/mg ratio: Not available
- Conductivity: Not available
- Salinity: Not available
- Culture medium different from test medium: Not available
- Intervals of water quality measurement: days 1,4 and 7 for each exposure concentration


OTHER TEST CONDITIONS
- Adjustment of pH: Not available
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 150 - 400 foot candles


EFFECT PARAMETERS MEASURED: mortality and number of young were assessed daily


RANGE-FINDING STUDY
- Test concentrations: 0-0.38 mg/L (see section 6.1.3., acute test, for details)
- Results used to determine the conditions for the definitive study: Yes, the results of the acute toxicity test were used to establish test concentrations for the chronic test.

Reference substance (positive control):

no

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

0.204 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

1.3 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

7 d

Dose descriptor:

other: IC20

Effect conc.:

0.38 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

not specified

Remarks on result:

other: 0.25 - 0.45

Details on results:

- Mortality of parent animals: See section below (Remarks on results including tables and figures)
- No. of offspring produced per day per female: See section below (Remarks on results including tables and figures)
- Body length and weight of parent animals: Not available
- Type and number of morphological abnormalities: Not available
- Type and number of behavioural abnormalities: Not available
- Number of males and females (parental): Not available
- Time to first brood release or time to hatch: Not available
- Egg development time: Not available
- Brood size: Not available
- Time to sexual maturity: Not available
- Type and magnitude of biochemical changes: Not available
- Other biological observations: Not available
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

One-way analysis of variance was used to determine the NOEC and LOEC effect concentrations. The EC20 was determined using a nonlinear regression approach as described by Bruce and Versteeg (1992). All analyses of variance were conducted using Minitab (1993).

Chronic Effects of C16AS on Ceriodaphnia dubia (7 days; study 66165)

Actual Concentration (mg/L)	% Mortality	Neonates per Female	S.D.
0	10	22.8	4.3
0.02	0	26.5	3.9
0.08	0	23.6	3.2
0.20	0	25.1	1.5
0.80	0	11.8*	4.7
1.29	10	4.7*	2.9

*indicates a significant difference from control

C16AS = C16 -alkyl sulfate

Validity criteria fulfilled:

yes

Remarks:

80% or greater survival in controls, 15 or more young per surviving female

Conclusions:

The 7-day NOEC of C16AS (C16-alkyl sulfate) to Ceriodaphnia dubia was 0.20 mg/L, based on measured concentrations of test substance.

Executive summary:

In a 7-day chronic toxicity study, Ceriodaphnia dubia were exposed to C16AS (C16-alkyl sulfate) at nominal concentrations of 0, 0.05, 0.10, 0.50, 1.0 and 2.0 mg/L, and measured concentrations of 0, 0.02, 0.08, 0.20, 0.80 and 1.29 mg/L under flow-through conditions. The 7-day NOEC based on measured concentrations was 0.20 mg/L, based on the most sensitive endpoint (reproduction). The toxicity study is classified as acceptable and satisfies the validity critieria as stated in the study protocol.

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods 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: proposed procedure for prolonged toxicity testing by UBA Berlin, Texte 16/85 (No. 5), p 133-142

Principles of method if other than guideline:

Method corresponding to OECD Guideline 202, part 2.

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Details on test conditions:

20 daphnia per test concentration 5/vessel.
Exchange of test solution 3 times/week.

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

16.5 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

55.5 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Reference 3

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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: Cited as OECD Guide-line 202, part 2 (Daphnia sp., Reproduction Test)

Deviations:

no

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

Test organism: Daphnia magna
- Common name: water flea
- Source: no data
- Age: less than 24 h old, females
- Feeding during test: no data

Test type:

semi-static

Water media type:

not specified

Total exposure duration:

21 d

Details on test conditions:

TEST SYSTEM
- Test vessel: no data
- No. of vessels per concentration (replicates): 20
- No. of concentrations tested: 5 + control

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 12 hours dark/ 12 hours light

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

4.2 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: 1.9 - 6.2 mg/L

Reference 4

Endpoint:

long-term toxicity to aquatic invertebrates

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

Key result

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

0.204 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Remarks on result:

other: read-across from CAS 1120-01-0

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

16.5 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Remarks on result:

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

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

4.2 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

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

Description of key information

7d NOEC (Ceriodaphnia dubia) = 0.204 mg/L (measured concentration, read-across)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.204 mg/L

Additional information

Since no reliable long-term toxicity tests with aquatic invertebrates are available for C16-20AS Na (CAS 191648-55-4), 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 from C16AS Na (CAS 1120-01-0) and C16-18AS Na (CAS 68955-20-4) were used, since toxicity of alkyl 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. The test results with the C18 AS homologue CAS 1120-04-3 were disregarded and are not presented. Since C18-AS is insoluble in calcium-containing water (i.e., Ceriodaphnia test waters), the effects (NOEC = 0.602 mg/L) are due to physical interactions, not the classic uptake into the organism and then elicit toxicity.

For the PNEC derivation, the NOEC value determined for the C16 homologue is used as the worst case scenario of C16 -20 AS Na (CAS 91648-55-4).

The key, non-GLP, 7-day reproduction toxicity test with Ceriodaphnia dubia performed according to EPA-600/489/001 guideline is available for C16AS Na (CAS 1120-01-0, P&G 1996). Daphnids were exposed under flow-through conditions to five test concentrations up to 1.29 mg/L (measured concentrations). Mortality and reproduction were evaluated daily. The NOEC value for reproduction determined after 7 days of exposure to test substance was 0.204 mg/L (measured concentration). This value is further used for derivation of PNEC freshwater value of C16-18AS Na (CAS 68955-20-4).

Moreover, a long-term test performed according to UBA procedure 16/85 (No. 5) with C16-18AS Na (CAS 68955-20-4) is available (Steber 1988). Daphnia magna were exposed for 21 days under semi-static conditions to four test concentrations. The 21-day NOEC value based on reproduction was 16.5 mg/L (nominal concentration). No analytical monitoring of test concentrations is available. An additional non-GLP long term test with C16-18AS Na (CAS 68955-20-4, Verge 2000) was performed according to OECD 202 guideline with Daphnia magna. Daphnids were exposed under semi-static conditions for 21 days to five concentrations of the test substance. No analytical monitoring is available. The 21-day EC50 value of 4.2 mg/L (nominal concentration) is provided.

Due to structure 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 chronic NOEC value of 0.204 mg/L is used for the PNEC derivation as the worst case scenario.