4-O-β-D-galactopyranosyl-D-glucitol

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 2

Reference Type:

other: Published secondary source

Title:

Lactitol

Author:

WHO/FAO

Year:

1983

Bibliographic source:

WHO/FAO: Expert Committee on Food Additives Summary of Toxicological Data of Certain Food Additives Series 18 (http://www.inchem.org/documents/jecfa/jecmono/v18je10.htm)

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

exposure was for 24 hours

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: ISO/DIS 634, Draft International standard

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-O-β-D-galactopyranosyl-D-glucitol

EC Number:

209-566-5

EC Name:

4-O-β-D-galactopyranosyl-D-glucitol

Cas Number:

585-86-4

Molecular formula:

C12H24O11

IUPAC Name:

4-O-beta-D-galactopyranosyl-D-glucitol

Specific details on test material used for the study:

Test material:
- lactitoldihydrate (provided by CCA).
- tests carried out with a sample of the homogenized lot sent to CIVO-TNO.

Sampling and analysis

Analytical monitoring:

not specified

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Test organisms:
- Animals were cultured at TNO in dilution water.
- Daphnia magna had a generation time of about 7 days and the average life time about 6 weeks. A nimals less than 24 hrs old were used for the tests.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

24 h

Test conditions

Hardness:

250 mg/L as CaCO3

Test temperature:

Not specified

pH:

8.2 ± 0.2

Nominal and measured concentrations:

10000 mg/L

Details on test conditions:

Since the test substance was not thought to be toxic, only one concentration (10000 mg/L) in dilution water was tested and compared with untreated dilution water.

Results and discussion

Effect concentrations

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Details on results:

The oxygen concentration at the end of the test was 8.5 mg/L in the untreated dilution water and 7.9 mg/L in the dilution water containing 10000 mg/L test substance. The pH in both solutions was 7.8 ± 0.1. No immobilization of any Daphnia occurred during the 24-hr exposure period in the untreated dilution water or in the dilution water containing 10000 mg/L test substance.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

LC50 (Daphnia magna): > 10000 mg/L

Executive summary:

The toxicity to Daphnia magna was examined in accordance with OECD Guideline 202. Lactitoldihydrate at a nominal concentration of 10000 mg/L did not show any acute toxicity for Daphnia magna. The LC50 for Daphnia magna was determined to be > 10000 mg/L