Undecyl glucoside

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:

key study

Study period:

27 - 31 Jan 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 203 (Fish, Acute Toxicity Test) as adapted by OSPAR commission (ref number 2005-11) protocol for a fish acute toxicity test amended March 2005

GLP compliance:

yes

Remarks:

GLP administered by the UK Dept of Health as stated by the study director.

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: poorly soluble materials were prepared as water accommodated fractions (WAFs). Floating or settled particles were observed at a concentration of 1000 mg test item/L in seawater after 20 h stirring. Therefore, the test substance was characterized as poorly soluble in seawater. The stocks were prepared and stirred in glass tanks with an appropriate volume of treated seawater and the required weight of test material added. The required volume is then siphoned into the appropriate test tank.

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

TEST ORGANISM
- Common name: turbot (flatfish)
- Source: Ardtoe Hatchery
- Amount: 0.575 g fish/L
- Weights of control fish: 1.34 - 2.61 g
- Length of control fish: 3.54 - 4.25 cm

ACCLIMATION
- Acclimation period: acclimatised to laboratory conditions for 10 d before test commencement
- Type of food: food in pellet form and libitum
- Feeding frequency: twice daily
- Health during acclimation (any mortality observed): no mortalities during this period
- Aeration: gentle aeration
- Holding vessel: 200 L capacity polythene tanks (flow-through conditions)
- Source/preparation of dilution water: 1 μm filtered ultraviolet treated seawater

Test type:

semi-static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

13.6 - 16 °C

pH:

7.69 - 8.03 (in vessels with test item), 7.76 - 8.07 (in controls)

Dissolved oxygen:

92 - 98%

Salinity:

35 - 37‰

Nominal and measured concentrations:

Nominal concentration: control, 37.6 mg/L (loading rate)

Details on test conditions:

TEST SYSTEM
- Test vessel: 14 or 30 L capacity moulded soda-lime glass tanks containing the appropriate volume of test media
- Renewal rate of test solution: replacement of media after 48 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.575 g fish/L (average)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: natural local seawater is pumped to holding tanks from Scapa Flow, Orkney. The treatment process was: sand filtered to remove particulate, filtered to 1 μm, heated to 16 ºC, UV treated, degassed and held at a quantity of 3000 to 5000 L. The water is constantly pumped through the system and trickle replenished as the water is used.
- Intervals of water quality measurement: measurement of water quality (dissolved oxygen, pH, temperature and conductivity or salinity) are carried out in the test concentration and control tank prior to and following each renewal of media.

OTHER TEST CONDITIONS
- Photoperiod: constant illumination

EFFECT PARAMETERS MEASURED: all vessels were checked at 24 h intervals

TEST CONCENTRATIONS
- Range finding study: a limit test was conducted using the lowest LC/EC50 concentration from either the Acartia tonsa or Skeletonema costatum tests, whichever was the most sensitive. Where significant mortality occurs in the fish test, a second stage limit test was conducted using a concentration lower than the first limit test, otherwise the study was considered complete at this point. A 96h Rangefinding test was conducted at the concentrations derived from the limit tests, five fish were exposed per concentration.

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 37.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mortality (fish)

Details on results:

At the 24 h stage one fish was removed from the test tank and euthanized after it sustained a damaged jaw and appeared distressed. This is not thought to have affected the test result, as at test conclusion no further mortalities were recorded for this test material or in the control tank.

Sublethal observations / clinical signs:

Table 1: Weights and lengths of control fish

Fish	Weight (g)	Length (cm)
1	1.95403	3.82
2	2.61035	4.25
3	1.92801	3.98
4	1.8289	3.83
5	1.33675	3.54
6	1.7229	3.8
7	1.84991	3.86
Average	1.89012	3.87
Fish loading density = 0.575 g/L

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

8 - 23 Jun 2009

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)

Qualifier:

according to guideline

Guideline:

other: European standard NF EN 1484 (July 1997, French version) Water analysis - Guidelines for the determination of total organic carbon (TOC) and dissolved organic carbon (DOC)

GLP compliance:

yes

Remarks:

based on statement of the study director

Analytical monitoring:

yes

Details on sampling:

- Sampling method: test solutions used for TOC analysis were placed simultaneously and under the same conditions as the other flasks of the test
- Sample storage conditions before analysis: the quantification of the samples was realized within the same day of the collection

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: prepared from 1 g/L stock solution of the test item previously diluted in fish dilution water

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: HB Developpement elevage, La Fond Garel, 69490 St Forgeux
- Length at study initiation: 25 - 30 mm
- Feeding during test: no

ACCLIMATION
- Acclimation period: minimum 12 d
- Acclimation conditions: in dilution water

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

240 - 250 mg/L (as CaCO3)

Test temperature:

22.9 - 24°C

pH:

7.4 - 8.2

Dissolved oxygen:

77 - 98%

Nominal and measured concentrations:

Nominal test concentrations: control, 1, 10 and 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 15 x 15 x 20 cm aquarium
- Material, size, headspace, fill volume: 2 L
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (containing fish): 1
- No. of vessels per control (without fish): 1
- Biomass loading rate: 1.1 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Ca/mg ratio: CaCl2 x 2 H2O: 294 mg/L / MgSO4 x 7 H2O: 123.3 mg/L
- Intervals of water quality measurement: temperature, pH and dissolved oxygen were measured every 24 h. TOC was measured at the start and at the end of the study at the 100 mg/L test item concentration and in the two controls.

OTHER TEST CONDITIONS
- Photoperiod: 14 h light/ 10 h darkness

EFFECT PARAMETERS MEASURED: dead fish were reported every 24 h and removed

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no

Results with reference substance (positive control):

- LC50 (24 h): 236 mg/L (between 189 - 301 mg/L)

Sublethal observations / clinical signs:

Table 1: Results of the TOC analysis of the definitive test in mg/L at the beginning of the test and before renewal at 24 h.

Nominal test item concentrations in mg/L	Total Organic Carbon
	at 0 h	at 24 h
Dilution water control (6 samples)	< Fish dilution water Limit Of Quantification (2 mg/L) (0.0/0.0/0.0/0.0/0.0/0.0)	< Fish dilution water Limit Of Quantification (2 mg/L) (0.1/0.1/0.1/0.1/0.0/0.0)
Dilution water control (without fish, 6 samples)	< Fish dilution water Limit Of Quantification (2 mg/L) (0.0/0.0/0.0/0.0/0.0/0.0)	< Fish dilution water Limit Of Quantification (2 mg/L) (0.0/0.0/0.0/0.0/0.0/0.0)
100 (3 samples)	mean: 10.4 (10.8/10.3/10.1)	mean: 18.2 (18.1 /18.6/17.9)

The total organic carbon concentrations measured in the test solutions were lower than the fish dilution water Limit of Quantification for the two controls, at the start and before renewal at 24 h. The total organic carbon concentration measured in the 100 mg/L concentration has not been satisfactorily maintained within +/- 20% of the nominal concentration during 24 h.

Table 2: TOC results obtained by the additional non-GLP study. NPOC and TC-IC method are compared.

	Total carbon (mg/L)			Inorganic carbon (mg/L)			Total Organic Carbon (mg/L)	NPOC(mg/L)
	Replicate		mean	Replicate		mean		Replicate		mean
T0	a	36.4	36.3	a	8.4	8.4	27.9	a	13.3	12.3
	b	36.6		b	8.4			b	11.8
	c	36		c	8.5			c	11.7
T24 h	a	36.4	36.9	a	9	9	27.9	a	18	17.3
	b	37		b	9			b	16.4
	c	37.2		c	9			c	17.6
			Difference between T0 and T24 h				0%	+40%

Results from the additional non-GLP study analyzed TOC by the NPOC and the TC-IC methods. Results from the NPOC method showed increase of the test item concentrations between T0 and T24. It is therefore assumed that the test item is instable in acid medium. TOC measurements performed without sample acidification (TC-IC method) demonstrate that the test item is stable in the aqueous medium.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Insuficient data available (only key results are summarized in the report, no description of the methods, no reference on analytics is given)

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

not specified

Details on test organisms:

TEST ORGANISM
- Common name: ide
- Length at study initiation (length definition, mean, range and SD): 5 - 7 cm

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

20 ± 1 °C

Nominal and measured concentrations:

Nominal test concentrations: control, 200, 300, 400, 500 and 1000 mg/L

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

400 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

LC0 (96 h) = 300 mg/L

LC100 (96 h) = 500 mg/L

Table 1: Dead fish per concentration

Test item concentration in [mg/L]	200	300	400	500	1000
Dead fish [%]	0	0	50	100	100

Description of key information

LL50 (96 h) > 37.6 mg/L (nominal, WAF) for Scophthalmus maximus (OECD 203, adapted by OSPAR commission)

Additional information

Three studies, in which the short term toxicity of D-Glucopyranose, oligomeric, undecyl glycoside (CAS 98283-67-1) to fish was investigated are available.

 

The study by Opus Plus Limited (2009) was chosen as the key study. It was conducted according to GLP and OECD guideline 203 as adapted by OSPAR commission (ref number 2005-11). The study was conducted as a limit test. In a semi-static test system with seawater, the test organism Scophthalmus maximus, was exposed to a single nominal loading rate of 37.6 mg/L, prepared as water accommodated fraction (WAF), as the test item was found to be poorly soluble in seawater. No analytical monitoring was performed in this study. No mortalities were observed during the 96 h test period and thus the LL50 was determined to be > 37.6 mg/L.

 

A further supporting study of reliability 1 is available, including analytics. The test was conducted under GLP in a semi-static freshwater system according to OECD guideline 203 (FCBA, 2011). TOC analysis was performed for the highest test concentration at the beginning and at the end of the study. The test organism Danio rerio was exposed to 1, 10 and 100 mg/L test item concentrations for 96 h. No effect was observed up to the highest tested concentration resulting in a LC50 > 100 mg/L (nominal) based on fish mortality. Although the study was valued as reliable 1, it is used only as supporting study since the study by Richardson (2009) provides the lowest effect value.

 

A brief summary of a study testing the toxicity of the test item to Leuciscus idus as the test organism is available. The test was conducted according to the OECD guideline 203 (TNO, 1999). The test organism was exposed in a freshwater static system to 200, 300, 400, 500 and 1000 mg/L test item for 96 h. No analytical monitoring is reported. The test resulted in a LC50 of 400 mg/L (nominal). The test report is not sufficiently detailed in order to use it for risk assessment or classification purposes and thus was considered as reliable 4 only.

 

In conclusion, based on the data listed above, D-Glucopyranose, oligomeric, undecyl glycoside (CAS 98283-67-1), does not show short term effects to fish under tested conditions.