D-glucopyranose, oligomers, xylityl glycosides and 1,4 anhydro D-xylitol and D-xylitol

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OCDE guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Directive CE - méthode C2 et OCDE 202.

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2003-02-13

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

446-990-1

EC Name:

-

Molecular formula:

C5H11O5 [C6H10O5]1.45 and C5H10O4 and C5H12O5

IUPAC Name:

2-(hydroxymethyl)oxolane-3,4-diol; 5-{[2,3,4,5-tetrahydroxy-6-(xenoniooxy)hexyl]oxy}pentane-1,2,3,4-tetrol; pentane-1,2,3,4,5-pentol

Test material form:

solid: compact

Details on test material:

Sponsor's identification
Description: yellow solid block
Batch number: 173 JG1
Date received: 29 april 2005
Storage conditions: room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna derived from in-house laboratory cultures.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

CA 250 mg CaCO3/L

Test temperature:

from 20.8 to 21.3 °C

Dissolved oxygen:

8.2 to 8.3 mg O2/L

Nominal and measured concentrations:

nominal concentration: 0 and 100 mg/L
measured concentration:

Details on test conditions:

200 mL glass jars
5 daphnids in each vessel
four replicates test and control vessels were prepared

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Results with reference substance (positive control):

48h-EC50 was 1.1 mg/L
NOEC= 0.56 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

48h-EC50> 100 mg/L
NOEC= 100 mg/L

Executive summary:

A study was performed to assess the acute toxicity of the test material to Daphnia magna. The method followed that described in the OECD guidelines for the testing of chemicals n°202, "Daphnia sp, acute immobilisation test" referenced as method C.2 of Comission Directive 92/69/EEC.

Methods

Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test material at a concentration of 100 mg/L for 48 hours at a temperature of 20.8 to 21.3 °C under static conditions. Immobilisation and any adverse reactions to exposure were recorded after3, 24 and 48 hours.

Results

The 48 -hour EC50 for the test material to Daphnia magna based on nominal test concentrations was greater than 100 mg/L and correspondingly the No Observed Effect Concentration was 100 mg/L.

Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 99% to 108% of nominal value and so results are based on nominal test concentrations only.

It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.

The 48h-EC50 for the reference material to Daphnia magna based on nominal concentrations was 1.1 mg/L with 95% confidence limits of 0.97 - 1.2 mh/L. The No Observed Effect Concentration was 0.56 mg/L.