4-O-β-D-galactopyranosyl-D-glucitol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

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:

publication

Title:

Summary of Toxicological Data of Certain Food Additives Series 18: Lactitol

Author:

WHO/FAO: Expert Committee on Food Additives.

Year:

1983

Bibliographic source:

http://www.inchem.org/pages/jecfa.htm

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

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):

Poecilia reticulata

Details on test organisms:

Test Organisms:
- Animals were cultured at TNO in dilution water.
- Poecilia reticulata had a generation time of about 6 months and the average life time was about 2 years. Animals of 3-4 weeks old were used for the tests.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

24-hour periods between renewals of dilution water containing test substance

Test conditions

Hardness:

250 mg/L CaCO3

Test temperature:

25⁰C

pH:

8.2 ± 0.2

Nominal and measured concentrations:

10000 mg/L

Details on test conditions:

The semi-static procedure, with renewal of test solutions every 24 hours, was used since the test substance might be biodegradable. The test solutions were aerated. The test was performed in duplicate. Ten fish were used per test vessel with one litre test solution.

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Details on results:

The oxygen concentration in all solutions was ≥75% of the saturation value throughout the test. The pH of the untreated dilution water was 8.2 ± 0.2 throughout the test. The pH of the dilution water containing 10000 mg/L of the test substance dropped to 7.5 during the 24-hr period between renewals. No fish died or showed any sign of bad health during the 96-hr exposure period in the untreated dilution water or in the dilution water containing 10000 mg/L test substance. During the 24 hr periods between renewals, the dilution water containing 10000 mg/L test substance turned turbid, probably indicating growth of bacteria and thus degradation of the test substance.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

LC50 (Poecilia reticulata): >10000 mg/L

Executive summary:

The toxicity to fish (Poecilia reticulata) was examined in accordance with OECD Guideline 203. Lactitoldihydrate at a nominal concentration of 10000 mg/L did not show any acute toxicity for Poecilia reticulata. The LC50 for Poecilia reticulata was determined to be >10000 mg/L.