D-Glucose, reaction products with alcohols C16-18 (even numbered)

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:

13 Jul - 16 Jul 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: National guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: DIN 38412 part 11

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 300 and 1000 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test concentration was prepared by direct weighing of the test substance into synthetic water due to its insolubility. After mixing, the test substance was treated with ultrasound for approximately 1 minute.
- Controls: 2

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: identical with the strain of BGA WaBoLu
- Source: own breeding (Henkel KGaA, TFB Ökologie)
- Age at study initiation: 6 to 24 hours
- Food type: green algae (Chlorella kessleri)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 - 21 °C

pH:

7.6 - 8.4

Dissolved oxygen:

78 - 115% at 0 - 3000 mg/L, 20% at 10000 mg/L after 48 h

Nominal and measured concentrations:

nominal concentrations: 0; 100; 300; 1000; 3000; 10,000 mg/L

Details on test conditions:

TEST SYSTEM
- Aeration: no additional aeration
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic water
- Intervals of water quality measurement: Measurements of O2 and pH were conducted after 48 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3 to 3.33

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3 160 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Mortality in control < 10%. Effect concentrations exceeding solubility of substance in test medium. Increasing test concentrations led to higher occurence of undissolved particles of test substance at the surface of the test medium. Therefore, it is suggested that the air supply was reduced depending on the test substance concentration. The oxygen saturation was only 20% at a concentration of 10,000 mg/L which may explain the immobility of all test organisms. TOC-Analytics was not applicable for the test substance. But the chosen DOC-Analytics was also not suitable to investigate the test substance.

Results with reference substance (positive control):

Effect of the reference substance was not determined due to narrow interval of the tested concentrations.

Table 1: Analytical results.
Nominal concentration of		Measured concentration after
mg Product/L	mg DOC/L	0 h (14 Jun)	24 h (15 Jun)	48 h (16 Jun)
		mg DOC/L	mg DOC/L	mg DOC/L
300	1.9	3.1	2.1	1.5
1000	6.4	6.3	3.1	3.6

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

15 - 18 May 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: ISO 14669 (1999) Water Quality - Determination of acute lethal toxicity to marine copepods (Copepoda: Crustacea); ISO 5667-16 (1998) Water Quality sampling - Guidance on biotesting of samples

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water-accommodated fraction (WAF) in UV-sterilised and filtered to 0.2 µm seawater

Test organisms (species):

other aquatic crustacea: Acartia tonsa

Details on test organisms:

TEST ORGANISM
- Strain: T10
- Age at study initiation: 19 days
- Feeding during test
- Food type: algal diet

Test type:

not specified

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

not stated

Test temperature:

18.9 - 21.1 °C

pH:

7.94 - 8.29

Dissolved oxygen:

96 - 98%

Nominal and measured concentrations:

Nominal concentrations: control, 1.0, 1.8, 3.2, 5.6, 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL borosilicate glass crystallising dishes
- Type: slightly covered with soda glass watch covers
- fill volume: 50 mL
- 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

OTHER TEST CONDITIONS
- Adjustment of pH: 1M HCl or 1M NaOH

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.78
- Range finding study
- Test concentrations: 1, 10, 100, 1000 mg/L

Reference substance (positive control):

yes

Remarks:

3,5 Dichlorophenol

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

6.25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 4.14 - 9.43 mg/L

Duration:

48 h

Dose descriptor:

other: LC90

Effect conc.:

7.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Mortality of control: 0%

Results with reference substance (positive control):

48 h LC50: 0.86 mg/L (95% CL: 0.73 - 1.03 mg/L)

Reported statistics and error estimates:

LC50 values were calculated from the propotional response data using the moving average angle method (USEPA, 1985) or an appropriate method from the ToxCalc Version 5 package.

All the guideline criteria and values were fulfilled. The LC50 was at 6.25 mg/L (48 h). No effects were observed at 1.8 mg/L after 48 h.

No chemical analysis was performed.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: D-Glucopyranose monomers and oligomers and fatty alcohols C16 / C18 linear
• the metabolism pathway leads to comparable products (Glucose and glucose oligomers) and non-common products predicted to have no toxicological effects (long chain fatty alcohols).

Therefore, read-across from the existing acute toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see attached justification

3. ANALOGUE APPROACH JUSTIFICATION
see attached justification

4. DATA MATRIX
see attached justification

Justification attached at chap. 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

6.25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Conclusions:

Test results from two read-across substances are considered:

1: (key, Henkel, 1993, R9300128, RL2) with test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
30% of test material consists of the target substance;
accordingly the EC50 of the original test material (3150 mg/l) is reduced to 30%: EC50>945mg/l


2. (supporting, BASF, 2001a, BPCN, R0100640-11, RL2) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides)
The LC50 was at 6.25 mg/L (48 h). No effects were observed at 1.8 mg/L after 48h.

The second test was performed with a test material having the same chemical structures as the target substance but instead of C16/C18 fatty alcohols the source substance contains C10-C16 fatty alcohols.

As a worst case approach, the lowest LC50 is used: daphnia acute 96-LC50 = 6.25mg/L

Description of key information

Test results from two read-across substances are considered:

1: (key, Henkel, 1993, R9300128, RL2) with test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols

30% of test material consists of the target substance;

accordingly the EC50 of the original test material (3150 mg/l) is reduced to 30%: EC50>945mg/l

2. (supporting, BASF, 2001a, BPCN, R0100640-11, RL2) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides)

The LC50 was at 6.25 mg/L (48 h). No effects were observed at 1.8 mg/L after 48h.

The second test was performed with a test material having the same chemical structures as the target substance but instead of C16/C18 fatty alcohols the source substance contains C10-C16 fatty alcohols.

As a worst case approach, the lowest LC50 is used: daphnia acute 96-LC50 = 6.25mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

6.25 mg/L