Undecyl glucoside

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 - 09 Jan 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

other: ISO 14669 (1999) Water Quality - Determination of acute lethal toxicity to marine copepods (Copepoda; Crustacea)

Qualifier:

according to guideline

Guideline:

other: ISO 5667-16 (1998) Water Quality Sampling – Guidance on biotesting of samples

GLP compliance:

yes

Remarks:

GLP was administered by the UK Dept of Health, according to statement of the study director.

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: floating and settled particles, were observed after 20 h stirring of 1000 mg/L test item in sea water. Therefore the test item was classified as poorly soluble in sea water and exposures were carried out with water accommodated fractions (WAFs) of the test material. WAFs were prepared by the direct addition of the required nominal weights or volumes to seawater followed by gentle stirring for approximately 20 h followed by a settling period of approximately 1 h. After this settling period, the middle phase of the preparation was siphoned, avoiding incorporation of undissolved particles, if present. If suspended material was observed then centrifugation of the stocks was performed.

Test organisms (species):

other: Acartia tonsa

Details on test organisms:

TEST ORGANISM
- Common name: copepod
- Strain: CCAP 1077/5
- Source: Dunstaffnage Marine Laboratory
- Culturing: in flowing 0.45 μm filtered ultra violet treated sea water, supplied by pump from Scapa Flow in Orkney. The cultures were maintained on a mixed algal diet comprising of between 2 and 4 species.
- Culture number: T8
- Age at study initiation: 19 d

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

19.7 - 21.4

pH:

8.34-8.36 (at 0 h)

Dissolved oxygen:

90 - 96%

Salinity:

36‰ (at 0 h in dilution water)

Nominal and measured concentrations:

Nominal test concentrations: control, 10, 18, 32, 56 and 100 mg/L (loading rate)

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL capacity borosilicate glass crystallising dishes
- Fill volume: 50 mL of test medium covered with soda glass watch covers
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: natural seawater is supplied by pump from Scapa Flow, Orkney. Seawater was UV sterilised and filtered to 0.2 μm and should be within a salinity of 36±4‰.
- Intervals of water quality measurement: measurement of water quality (dissolved oxygen, pH and temperature) were carried out in one replicate at each concentration at 0 h and 48 h. Salinity measurement was carried out in the control medium at 0 h.

OTHER TEST CONDITIONS
- Adjustment of pH: if, at 0 h, the pH of the dilution water was outwith the pH range of 8±0.3 then pH was returned to within these limits by adjustment with either 1M HCl or NaOH as was appropriate. If the pH required adjustment, a stirring period was required to ensure the pH remained constant.

EFFECT PARAMETERS MEASURED: observation of mortalities were carried out at 24 h and 48 h.

TEST CONCENTRATIONS
- Range finding study: yes, LL50 (48 h) = 55 mg/L (WAF)
- Test concentrations: 4 controls and test item concentrations of 1, 10, 100, 1000 mg/L (nominal).
- Results used to determine the conditions for the definitive study: based on LL50 of 55 mg/L, concentrations between 10 and 100 mg/L (nominal) were used.

Reference substance (positive control):

yes

Remarks:

3,5 DCP (Dichlorphenol) at 0.10, 0.32, 1.0, 1.8 and 3.2 mg/L

Duration:

48 h

Dose descriptor:

LL50

Effect conc.:

60.19 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mortality

Remarks on result:

other: 95% CI: 28.43 - 86.10 mg/L

Details on results:

- Mortality of control: 4.8% (lower than 10% requested by the guideline )

Results with reference substance (positive control):

- LC50 (48 h): 0.96 (95% CI: 0.54 - 4.56 mg/L)
- pH: 8.20 - 8.21
- Temperature: 20.4 - 20.9°C
- Dissolved oxygen: 95 - 97%

Reported statistics and error estimates:

The effect concentrations were calculated by the appropriate statistical method of ToxCalc Version 5 software.

Table 1: Mortality of Acartia tonsa after 24 and 48 h exposure

Concentration (mg/L)	Number/dead immobile at 24h		Number dead/immobile at test termination		Total exposed	Proportional response
	Replicate a	Replicate b	Replicate a	Replicate b		24h	48h
10	0	0	3	0	20	0	0.15
18	0	0	1	1	20	0	0.10
32	0	1	1	2	19	0.05	0.16
56	2	0	4	5	19	0.11	0.47
100	9	10	9	10	19	1.00	1.00

Table 2: Effect values with 95% confidence limits

			95% Confidence limits (mg/L)
	LC50 (mg/L)		Lower	Upper	48 h LC90 (mg/L)	48 h NOEC (mg/L)
Test item	24h	75.41	63.77	85.77
	48h	60.19	28.43	86.1	92.04	32

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

07 - 20 Jul 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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 the statement of the study director

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

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

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Mehtod of breeding: in closed bottles placed in a climatic chamber free from any toxic vapor
- Length at study initiation: Daphnids used were previously filtered in order to obtain animals from a size between 560 - 800 µm
- Age at study initiation: less than 24 h
- Feeding during test: no

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 ± 1 °C

pH:

7.9 - 8.4

Dissolved oxygen:

8.3 - 8.6 mg O2/L

Nominal and measured concentrations:

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

Details on test conditions:

TEST SYSTEM
- Fill volume: 10 mL test solution (test containers were covered in order to avoid evaporation and dust deposition)
- Renewal rate of test solution: 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (containing daphnids): 6
- No. of vessels per control (without daphnids): 6

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Ca/Mg ratio: CaCl2 x 2 H2O = 297 mg/L / MgCl2 x 6 H2O = 167 mg/L
- Intervals of water quality measurement: pH, and dissolved oxygen of each test concentrations and controls were measured at the beginning and at the end of the test

OTHER TEST CONDITIONS
- Photoperiod: continous darkness

EFFECT PARAMETERS MEASURED: observations on the mobility of the Daphnids were made every 24 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Observations on stress after 48 h: no
- Mortality of control: no

Results with reference substance (positive control):

- EC50 (24 h): 1.11 mg/L (within the acceptable interval of 0.6 - 2.1 mg/L according to the international standard ISO 6341 May 1996)

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

Nominal test item concentrations in mg/L	Total Organic Carbon
	at 24 h*	at 48 h**
Dilution water control (6 samples)	< Daphnids dilution water Limit Of Quantification (4 mg/L) (0.2/0.2/0.6/0.7/0.5/0.4)	< Daphnids dilution water Limit Of Quantification (4 mg/L) (0.3/0.3/0.5/0.4/0.8/0.3)
Dilution water control (without Daphnids, 6 samples)	< Daphnids dilution water Limit Of Quantification (4 mg/L) (0.2/0.2/0.6/0.7/0.5/0.4)	< Daphnids dilution water Limit Of Quantification (2 mg/L) (0.2/0.2/0.2/0.2/0.3/0.2)
100 (3 samples)	mean: 11.5 (11.8/11.2/11.6)	mean: 18.2 (17.2 /18.9/18.4)
* because of semi-static conditions, these samples were aged for 0 h
** because of semi-static conditions, these samples were aged for 24 h

The total organic carbon concentrations measured in the test solutions were lower than the Daphnid dilution water Limit of Quantification for the two controls, at the start and before renewal after 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 aquatic invertebrates

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 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 ± 1°C

Nominal and measured concentrations:

Nominal test concentrations: 100, 500, 1000, 2000 and 2500 mg/L

Details on test conditions:

OTHER TEST CONDITIONS
- Photoperiod: no illumination

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

EC0 (48 h) = 500 mg/L

EC100 (48 h) = 2000 mg/L

Table 1: Effects observed at the tested concentrations

Test item concentration in mg/L	100	500	1000	2000	2500
Daphnie unable to swim [%]	0	0	50	100	100

Description of key information

LL50 (48 h) = 60.19 mg/L (nominal, WAF) for Acartia tonsa (ISO 14669)

Additional information

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

 

The study by Opus Plus Limited (2009) was chosen as the key study and was conducted according to ISO 14669 (1999) and GLP. In a semi-static system with saltwater the test organism Acartia tonsa was exposed for 48 h to nominal test loading rates of 10, 18, 32, 56 and 100 mg/L, prepared as water accommodated fractions (WAF), as the test item was found to be poorly soluble in seawater. No analytical monitoring was performed in this study. The LL50 was determined to be 60.19 mg/L (nominal, WAF).

 

A supporting study of reliability 1 is available, including analytical results. The test was conducted in a semi-static freshwater system according to OECD guideline 202 and GLP (FCBA, 2011). TOC analysis was performed for the highest test concentration at the beginning and at the end of the study. The test organism Daphnia magna was exposed to concentrations of 1, 10 and 100 mg/L test item for 48 h. No effect was observed up to the highest tested concentration resulting in an EC50 >100 mg/L (nominal) based on mobility. Although the study was valued as reliable 1, it was used only as supporting study since the study by Hudson (2009) provides the lowest effect value.

 

Only a brief summary of a further toxicity study with Daphnia magna is available. The study was conducted according to the OECD guideline 202 (Hygiene Institut, 1999). The test organism was exposed in a freshwater static system to 100, 500, 1000, 2000 and 2500 mg/L test item for 96 h. No analytical monitoring is reported. The test resulted in an EC50 of 1000 mg/L (nominal) based on mortality. 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 available data listed above, the most sensitive effect value determined for D-Glucopyranose, oligomeric, undecyl glycoside (CAS 98283-67-1) resulted in a LL50 (48 h) of 60.19 mg/L (nominal, WAF), obtained in a study with the marine crustacean Acartia tonsa.