Heparin, sodium salt

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

From November 8, 1999 to December 07, 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Abbreviated report but according to acceptable methods.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Heparin, sodium salt

Cas Number:

9041-08-1

IUPAC Name:

Heparin, sodium salt

Details on test material:

Batch n°EV1029

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (Cladocera crustacea)
- Strain: IRCHA
- Source: CRIT-D Laboratory

Study design

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Test conditions

Nominal and measured concentrations:

Test concentrations: 0.1-0.35-1-3.5-10-35-100 mg/kg

Details on test conditions:

Each solution was placed in a test vessel (Pyrex beakers 100 ml) at 40 g per container and 20 Daphnia were exposed by test vessel.

COMPOSITION OF TEST MEDIUM:
CaCl2, 2H2O: 0.294g
MgSO4, 7H2O: 0.12325g
NaHCO3: 0.06475g
KCl: 0.00575g
Bidistilled water: qsp 1000mL

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 other: mg/kg

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 other: mg/kg

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

CE50 24h is 1.1 mg/kg (CL 95%: 1.0-1.3 mg/kg) (tested on 05/10/99)
CE50 24h is 1.1 mg/kg (CL 95%: 1.0-1.3 mg/kg) (tested on 23/11/99)

Any other information on results incl. tables

The immobilisation percentage is 0 for each tested concentration for 24h or 48h exposure.

Applicant's summary and conclusion

Conclusions:

EC 50 48h of the purified sodium heparinate is greater than 100 mg/kg.