Heparin, sodium salt

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited study summary. Not GLP.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The effects on central nervous system of a new low molecular weight test substance (OP/LMWH) were studied in mice and rats. The effect of OP/LMWH on respiration, blood pressure and heart rate was studied in guinea-pigs and rats.

GLP compliance:

not specified

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

nonasodium 2-({6-[(2-carboxylato-4-hydroxy-6-{[6-hydroxy-5-(sulfonatoamino)-4-(sulfonatooxy)-2-[(sulfonatooxy)methyl]oxan-3-yl]oxy}-5-(sulfonatooxy)oxan-3-yl)oxy]-4-hydroxy-5-(sulfonatoamino)-2-[(sulfonatooxy)methyl]oxan-3-yl}oxy)-4-hydroxy-3-(sulfonatooxy)-3,4-dihydro-2H-pyran-6-carboxylate

EC Number:

700-834-1

Cas Number:

9041-08-1

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

nonasodium 2-({6-[(2-carboxylato-4-hydroxy-6-{[6-hydroxy-5-(sulfonatoamino)-4-(sulfonatooxy)-2-[(sulfonatooxy)methyl]oxan-3-yl]oxy}-5-(sulfonatooxy)oxan-3-yl)oxy]-4-hydroxy-5-(sulfonatoamino)-2-[(sulfonatooxy)methyl]oxan-3-yl}oxy)-4-hydroxy-3-(sulfonatooxy)-3,4-dihydro-2H-pyran-6-carboxylate

Details on test material:

Batch No.: 21-23
Purity: not specified

Test animals

Species:

other: mice, rats and guinea-pigs

Strain:

other: Swiss strain mice, Sprague-Dawley strain rats, guinea-pigs not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Mice weighing 18-20 g, rats weighing 230-280 g, guinea-pigs weighing 450-500 g.
- Housing: Housed in Makrolon cages
- Diet (e.g. ad libitum):Pelleted dry diet Altromin-R, Altromin-CL were available ad libitum.
- Water (e.g. ad libitum): Tap water was available ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 55-60%
- Air changes (per hr): 12 times/h
- Photoperiod (hrs dark / hrs light): 12:12 light/dark

No additional data

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

physiological saline

Analytical verification of doses or concentrations:

not specified

Results and discussion

Details on results:

1. Effect on general behaviour
The test substance, administered by intravenous route, did not cause any behavioural changes up to 1000 mg/kg in mice. At 1000 mg/kg, decrease of awareness and mood was observed.

2. Effect on spontaneous movement
The test substance at 2 and 10 mg/kg s.c. showed no effect on spontaneous movement of mice.

3. Effect on motor coordination
The test substance had no effect no motor coordination at 2 and 10 mg/kg s.c.

4. Anti-reserpine activity
The test substance at 2 and 10 mg/kg/s.c. did not show any antireserpine activity.

5. Effect on yohimbine-induced toxicity
The test substance at 10 mg/kg s.c. slightly increased the toxicity induced by yohimbine in mice.

6. Effect on apomorphine-induced stereotyped behaviour
The test substance, at 2 and 10 mg/kg s.c., showed no effect on apomorphine-induced stereotypy in rats.

7. Anticonvulsivant activity
The test substance, at 2 and 10 mg/kg s.c., did not inhibit electroshock-induced, pentetrazol-induced and strychnine-induced convulsions in mice.

8. Effect on pentobarbital-induced hypnosis
The test substance did not significantly prolong the sleeping time at 2, 5 and 10 mg/kg s.c.

9. Analgesic effect
The test substance up to 10 mg/kg s.c. did not exert any analgesic effect in the rat.

10. Anti-oxotremorine activity
The test substance at 2 and 10 mg/kg s.c. did not antagonize hypothermia and peripheral phenomena induced by oxotremorine.

11. Effect on blood pressure and heart rate
The test substance did not increase the blood pressure and heart rate in the rat up to 10 mg/kg i.v.

12. Effect on respiration
The test substance did not change the respiration rate of guinea-pigs up to 10 mg/kg i.v.

Applicant's summary and conclusion

Conclusions:

The test substance, up to 10 mg/kg/s.c., did not show any effect on central nervous system and did not increase the blood pressure, heart rate and respiration rate up to 10 mg/kg i.v.