Registration Dossier

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
Justification for type of information:
Hostapon SG and Acylglycinate GCK-12H-T are structurally closely related UVCB substances, which differ predominantly in the counterion (sodium resp. potassium). As the counter-ion itself is not expected to have any significant adverse effect contributing to substance toxicity, it can be assumed that the results obtained with Hostapon SG for this specific endpoint also apply to Acylglycinate GCK-12H-T.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
DOC analysis was performed only at the test start
GLP compliance:
yes (incl. certificate)
Remarks:
Dr. U. Noack-Laboratorien, Käthe-Paulus-Str. 1, D-31157 Sarstedt (Germany)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and of test material: Clariant Produkte (Deutschland) GmbH, Industriepark Höchst, Product Safety FUN, Geb. C 671, D-65926 Frankfurt am Main, Germany

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 concentrationsopen allclose all
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
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
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
29.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
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
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
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 29.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
In the limit test, the nominal test item concentration of 100 mg/L (=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-12H-T differ only in the counterion (sodium-potassium), it can be assumed that the obtained results with Hostapon SG also apply to acylglycinate GCK-12H-T.
Executive summary:

Experimental studies on the acute toxicity of acylglycinate GCK-12H-T to fish are not available. The acute toxicity of Hostapon SG which differs from acylglycinate GCK-12H-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 (=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-12H-T differ only in the counterion (sodium-potassium), it can be assumed that the results obtained with Hostapon SG also apply to acylglycinate GCK-12H-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