Reaction mass of stearoyl sarcosine and palmitoyl sarcosine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

see analogue justification attached to chapter 13

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.37 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: Reaction products of oleoyl sarcosine with sodium hydroxide, MAL, M 0409-1424/006-3, 2004, B. rerio, 96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.43 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: EC 701-177-3, Schill+Seilacher, 2010, LAUS, 09070901G504, D.rerio

Conclusions:

The LC50 (96h) for D. rerio is 0.37 mg/L (nominal).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A definite amount of the test substance (stock solution concentration: 350 mg/L) was weighted into measuring flask and the total volume was filled up with dilution water. The test bottles were conditioned about 15 min before the test was started.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Length at study initiation: 2.0 cm
- Feeding during test: none

ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): same as test
- Feeding frequency: daily

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

19.0 - 20.1 °C

pH:

7.7 - 8.1

Dissolved oxygen:

5.6 - 7.7 mg O2/L

Nominal and measured concentrations:

nominal: control, 0.1, 0.25, 0.5, 1.0, 2.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers
- Fill volume: 7 L
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water without chlorine (pH 8.0)
- Ca content: 37.4 mg/L

OTHER TEST CONDITIONS
- Photoperiod: 12 h light and 12 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality was recorded every 24 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.37 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%

Reported statistics and error estimates:

The statistical evaluation bases on a Probit analysis. The Probit transformation served for the graphical linearisation, the verification of the normal distribution of the experimental data and for the evaluation of the effective concentration.

Sublethal observations / clinical signs:

Table 1: Mortality

Concentration [mg/L]	Mortality of fishes [%]
	24 h	48 h	72 h	96 h
0.1	0	0	0	0
0.25	14	29	43	43
0.5	29	43	57	57
1.0	43	86	86	86
2.0	100	100	100	100

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

30 Jul - 03 Aug 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted in 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

adopted in 2008

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany

Analytical monitoring:

yes

Details on sampling:

- Concentrations: At test start, at test end and every 24 h, the test item concentration was determined.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: On the day of the start of the study, a stock solution containing 10 g/L test item in deionised water was prepared. 10 g test item was mixed with 1.1 g NaOH (45%). Then, 40 mL deionised water (80 – 100 °C) was added. After homogenisation with a glass stirrer, 85 mL deionised water (room temperature) was added. Then the vessel was stirred on a magnetic stirrer. NaOH (0.5 M) was added until the resulting solution was clear. The pH of the solution was adjusted to 7.8 ± 0.2 with 1 M HCl. The solution was transferred into a volumetric flask and filled up to 1 L with deionised water. From this stock solution, a solution (nominal concentration: 25 mg/L) in drinking water was prepared. This solution then was used to prepare the solution of the concentration to be tested.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Hamilton-Buchanan
- Source: Received on 08 Jul 2010 from Dehner Garten Center, Neustadt/Weinstrasse, Germany
- Age at study initiation: Sexually immature young fish
- Length at study initiation: 2 ± 1 cm
- Feeding during test: None

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Warmwater fish food and daphnia, totalling to about 1 - 2% of body weight per day
- Feeding frequency: three times a day until 24h prior to test start
- Health during acclimation (any mortality observed): Mortality was < 5%.

Test type:

flow-through

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

1.18 mM

Test temperature:

21.7 - 22.3 °C

pH:

8.1 - 8.4

Dissolved oxygen:

7.7 - 9.1 mg/L

Nominal and measured concentrations:

Nominal: 0.43 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquaria
- Material, size: Glass, 10 L
- Aeration: None
- Renewal rate of test solution (frequency/flow rate): approx. every 5 h
- No. of organisms per vessel: 8 (test item), 7 (control)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Drinking water
- Total organic carbon: < 1.0 mg/L
- Metals: Na 3.8 mg/L, K 2.4 mg/L, Ca 23.8 mg/L, Mg 1.9 mg/L, other metals < 0.0001 to < 0.01
- Pesticides: < LOD
- Chloride: 7.0 mg/L
- Ca/Mg ratio: 12.5:1
- Conductivity: 142 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: Oxygen concentration and pH were measured every 24 h.

OTHER TEST CONDITIONS
- Photoperiod: 12h light/12 h dark, neon tubes

EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Mortalities and abnormal behaviour were documented every 24 h.

TEST CONCENTRATIONS
- Results used to determine the conditions for the definitive study: Threshold approach concentration, lowest EC50 in alga and daphnia test

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.43 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 0.43 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

behaviour

Details on results:

- Behavioural abnormalities: None
- Mortality of control: None
- Mortality in the test vessels: None
- Analytics: 91% to 107% of the nominal concentration was measured at test start and every 24 h until test end.

Sublethal observations / clinical signs:

The substance showed a strong absorption, the test was performed with the highest achievable concentration in water.

Validity criteria fulfilled:

yes

Description of key information

LC50 (96 h) = 0.37 mg/L (nominal) for D. rerio (OECD 203); read-across

LC50 (96 h) > 0.43 mg/L (nominal) for D. rerio (OECD 203); read-across

Additional information

No studies investigating the short-term toxicity to freshwater fish are available for Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7). Therefore, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Reaction products of oleoyl sarcosine with sodium hydroxide and N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) were conducted.

The chemical properties of the target and source substances are similar due to the structural similarities, i.e., sarcosine head group and the hydrocarbon tail. In addition, due to the pKa of the target substance (pKa = 3.96, major constituent), at physiological pH values (above 6) the target substance is expected to be in the anionic form, as are the source substances. As a result, the chemistry of the target and source substances, in solution (above pH 6), are expected to be similar. The sodium cation (Na+) found in one source substance is not expected to create much difference in properties, particularly for solution behavior, such as Log Kow and water solubility. In aqueous solution, these cations are dissociated from the molecule. Thus, the source substances are considered suitable representatives for the evaluation of the toxicity to aquatic invertebrates of the target substance. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.

The study conducted with the source substance Reaction products of oleoyl sarcosine with sodium hydroxide and N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was performed according to OECD 203 (GLP) with the zebra fish Danio rerio. Fish were exposed to five nominal concentrations of 0.1, 0.25, 0.5, 1.0 and 2.0 mg/L. No analytical measurement was conducted. After an exposure of 96 h, a LC50 of 0.37 mg/L (nominal) was calculated.

The study conducted with the source substance N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was carried out according to OECD guideline 203 and GLP. In this limit-test, zebra fish (Danio rerio) were exposed to a concentration of 0.43 mg/L under flow-through conditions. Analytical measurements verified the test item concentration to be 91 – 107% throughout the exposure period. As no mortalities were observed, the LC50 was determined to be > 0.43 mg/L (nominal).

Based on the available results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5), which is characterized by a comparable structure and physico-chemical properties, it can be concluded that the target substance Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7) will exhibit comparable effects on freshwater fish.