Octasodium 2-(3,4-bis(sulfonatooxy)-2,5-bis(sulfonatooxymethyl)tetrahydrofuran-2-yloxy)-3,5-bis(sulfonatooxy)-6-sulfonatooxymethyltetrahydropyran-4-oxysulfonate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-08-22 to 1996-09-23

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 92/69/EWG, B.7

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Natrium Sucroseoctasulfat

IUPAC Name:

Natrium Sucroseoctasulfat

Test material form:

other: solution

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: Wasser (water)

Details on oral exposure:

Method of administration:
einmal täglich per Schlundsonde (gavage 1X

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 10 animals at 500 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Male: 10 animals at 2000 mg/kg bw/day
Female: 10 animals at 500 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 2000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:

Clinical observations:
Bei 200 mg/kg reduzierte KG-Entwicklung bei männlichen
Tieren in Wochen 3 und 4, korrelierend mit reduzierter
Futterverwertung in diesem Zeitraum.

Laboratory findings:
Keine behandlungsbezogenen Effekte ausserhalb des Bereichs
der Referenzwerte.

Effects in organs:
Keine behandlungsbezogenen Effekte auf Aussehen und Gewicht
der Organe sowie keine histopathologischen Befunde.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Classified as: Not classified

Executive summary:

The purpose of this study was to assess the toxicity of "Natrium Sucroseoctasulfat" in rats of the HsdBrl: WH starin when administered orally (7 days a week) over a period of 4 weeks.

The study was performed on 4 test groups, including 1 contraol group and 3 dose groups; each test group consisted of 10 males and 10 females.

Dose levels at 500 mg/kg (group II), 1000 mg/kg (group III) and 2000 mg/kg (group IV) were used. The concurrent control group (group I) was treated with tap water, which served as solvent for the test article.

Treatment with "Natrium sucroseoctasulfat" up to a dose level of 2000 mg/kg had no severe toxic effects on the observed parameters. Macroscopic and microscopic examinations did not give any indication of a test article influence. With regard to minor changes in clinical chemistry an the treatment influence on body weight development and food conversion rate in the 2000 mg/kg males, a "no observed effect level" of 1000 mg/kg can be stated.