Fatty acids, coco derivs., reaction products with glycine, potassium salts

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

21.08.2008 to 25.08.2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

study performed with N-cocoyl glycine sodium salt

Justification for type of information:

As Hostapon SG and acylglycinate GCK-11-T differ only in the counterion (sodium-potassium), it can be assumed that the results obtained with Hostapon SG also apply to acylglycinate GCK-11-T.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

DOC analysis was performed only at the test start

GLP compliance:

yes (incl. QA statement)

Remarks:

Dr. U. Noack-Laboratorien, Käthe-Paulus-Str. 1, D-31157 Sarstedt (Germany)

Test material

Test material information

Constituent 1

Reference substance name:

Glycine, N-coco acyl derivs., sodium salts

EC Number:

291-350-5

EC Name:

Glycine, N-coco acyl derivs., sodium salts

Cas Number:

90387-74-9

Molecular formula:

Molecular formula for this UVCB is not available.

IUPAC Name:

Glycine, N-coco acyl derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Clariant Produkte (Deutschland) GmbH, Industriepark Höchst, Product Safety FUN, Geb. C 671, D-65926 Frankfurt am Main, Germany; Batch No.: ESD0003028
- Expiration date of the lot/batch: 21.10.2009
- Purity test date: not reported

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from moisture and light

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

FORM AS APPLIED IN THE TEST (if different from that of starting material): Hostapon SG is a colourless aqueous liquid and was tested as such

Sampling and analysis

Analytical monitoring:

yes

Remarks:

The test item concentration in the test vessel and control were verified via DOC measurements according to guideline DIN EN 1484 at test start

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: AQUARIUM AM AEGI, Volgersweg 6, D-30175 Hannover (Germany)
- Length at study initiation (length definition, mean, range and SD): 2.80 cm (average value)
- Weight at study initiation (mean and range, SD): 0.21 g (average value)
- Method of breeding:At the test facility, the fish were kept at 23 +/-2°C and diffuse light (0.1-10 µmol photons/m² x s, natural photoperiod). The water was changed at least once a week. The fish were fed Stör perlets (SERA GMBH, Hamburg). The amount of food was 4% of the fish body weight per feeding day. Food was provided 3 times a week.. The test fish were not fed 24 h before the test started.

ACCLIMATION
- Acclimation period:12 d
- Acclimation conditions (same as test or not): same as in the test
- Type and amount of food during acclimation: The fish were fed Stör perlets (SERA GMBH, Hamburg). The amount of food was 4% of the fish body weight per feeding day.The test fish were not fed 24 h before the test started.
- Feeding frequency during acclimation: Food was provided 3 times a week..
- Health during acclimation (any mortality observed): Not reported: In the test, zebrafish were used with at least 12 d of acclimatisation and mortality <5% within these days before the study starts. No disease treatments were administered throughout holding and testing.

FEEDING DURING TEST: no

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

59 mg CaCO3/L

Test temperature:

22.1-22.4°C

pH:

7.23-7.62

Dissolved oxygen:

>=60% of air saturation (95-100%)

Nominal and measured concentrations:

100 mg/L test item (=29.8 mg/L a.i.; nominal each)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass-aquaria
- Type (delete if not applicable): aquaria were loosely covered by glass tops.
- Material, size, headspace, fill volume: glass/10 L/0/10 L
- Aeration: yes
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable (test performed under static conditions)
- Renewal rate of test solution (frequency/flow rate): not applicable (test performed under static conditions)
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): no vehicle used
- Biomass loading rate: <1 g fish/L test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin: water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine. Nominal parameter: total hardness: 10-250 mg CaCO3/L, pH: 6.0-8.5. The water is analysed biannual according to German tap water regulation

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: natural photoperiod
- Light intensity: 0.1-10 µmol photons/m² x s

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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: no
- Test concentrations: 100 mg/L nominal
- Results used to determine the conditions for the definitive study: no (not necessary)

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

29.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Effect concentrations 2

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

29.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 5

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 29.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Effect concentrations 6

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 7

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 29.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Effect concentrations 8

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

In the limit test, the nominal test item concentration of 100 mg/L test item (=29.8 mg/L a.i.) caused no mortality or non-lethal effects. Therefore, the 96 h NOEC and LC0 were laid down as 100 mg/L test item (=29.8 mg/L a.i.) and the 96 h-LC50 and LC100 were >100 mg/L test item (>29.8 mg/L a.i.; nominal each).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In a limit test with Hostapon SG, the 96 h NOEC and LC0 were found to be 100 mg/L test item (=29.8 mg/L a.i.) and the corresponding 96 h LC50 and LC100 values were >100 mg/L test item (>29.8 mg/L a.i.; nominal each). As Hostapon SG and acylglycinate GCK-11-T differ only in the counterion (sodium-potassium), it can be assumed that the obtained results with Hostapon SG also apply to acylglycinate GCK-11-T.

Executive summary:

Experimental studies on the acute toxicity of acylglycinate GCK-11 -T to fish are not available. The acute toxicity of Hostapon SG which differs from acylglycinate GCK-11 -T only in respect to the counterion (sodium instead of potassium cation) was therefore used for risk identification.

The acute toxicity of Hostapon SG to fish was investigated in a study conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test) under static conditions. In this limit test, tap water was used as dilution water and 7 fish each in the test vessel and control were observed for mortality and non-lethal effects for a period of 96 h. Hostapon SG did not cause any effects to zebrafish after 96 h when tested with a nominal concentration of 100 mg/L test item (equal to 29.8 mg/L a.i.). Based on this result, the 96 h NOEC and LC0 were determined to be 100 mg/L test item (=29.8 mg/L a.i.) and the corresponding 96 h LC50 and LC100 were >100 mg/L test item (>29.8 mg/L a.i.; nominal each). As Hostapon SG and acylglycinate GCK-11-T differ only in the counterion (sodium-potassium), it can be assumed that the results obtained with Hostapon SG also apply to acylglycinate GCK-11-T.

The study can be classified as reliable with restrictions and satisfying the guideline requirements for an acute toxicity study with fish. The restriction is based on the fact that the results were not obtained with the test item here under investigation but from a very similar substance.

Results Synopsis
Test organism size/age: Danio rerio (length: 2.8 cm; weight: 0.21 g)

Test Type: static

Results based on test item:

96 h NOEC, LC0: 100 mg/L test item
96 h LC50, LC100: >100 mg/L test item

96 h EC0, EC50, EC100: >100 mg/L test item (nominal each)

Results based on active ingredients:

96 h NOEC, LC0: 29.8 mg/L a.i.
96 h LC50, LC100: >29.8 mg/L a.i.

96 h EC0, EC50, EC100: >29.8 mg/L a.i. (nominal each)

Endpoint(s) Effected: mortality, behavior