[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Principles of method if other than guideline:

The study was performed according OECD Test Guideline n°407 "Repeated Dose Toxicity".

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid

Molecular formula:

(C14H19Na2NO14S)n

IUPAC Name:

2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

3750 mg/kg/d

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Animais were daily observed during the acclimatization period.
They were observed twice daily for seven days and more particularly for the six hours following the administration, except on saturday and sunday (only 2 hours after dosing).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 3 750 mg/kg bw

Based on:

test mat. (total fraction)

Mortality:

No mortalities, no clinical signs and no change of general conditions occurred during the whole observation period (7 days).

Clinical signs:

other: No mortalities, no clinical signs and no change of general conditions occurred during the whole observation period (7 days).

Gross pathology:

ACS did not elicited any change of absolute or relative weight of liver and kidneys at the end of the exposure period (7 days).
The only abnormality consisted in gastric ulcer-like lesions found in several control and treated animais (7 days).

Other findings:

No difference in food intake and water consumption between the control group and the treated group was noticed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A valid repeated dose oral toxicity study (duration: 7 days) showing no adverse effect at the dose level of 3750 mg/kg/d is used to conclude about acute oral toxicity of the substance.

In the conditions of this assay, daily oral administration of ACS at the maximum possible dose of 3750 mg/kg/D for seven consecutive days in male and female Sprague­ Dawley rats was concluded to be well tolerated.
This study is considered valid to conclude that the acute oral LD0 of ACS is > 3750 mg/kg. Consequently the GHS criteria for classification are not met.