Registration Dossier

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:
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. certificate)
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:
No mortalities, no clinical signs and no change of general conditions occurred during the whole observation period (7 days).
Body weight:
Body weight increase was similar and conform to the data for this species and strain in both groups.
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.