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Description of key information

The acute oral toxicity studies show that Balsalazide disodium and hence balsalazide acid are not toxic when administered to rats as a single oral dose of 2000 and 5000 mg/kg bw. No mortalities, adverse effects or clinical signs were observed during the studies. Therefore, the highest doses tested were considered to be the non-lethal doses and the LD50 in rats is considered to be greater than 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline is specified in the report.
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 1% methylcellulose or 0.9% NaCl
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2 g/kg bw
No. of animals per sex per dose:
10 animals per sex per dose
Control animals:
not specified
Details on study design:
All animals were observed for clinical signs and mortality for 7 days. At the end of the observation period, all animals were sacrificed and subjected to complete necropsy.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was observed during the test.
Clinical signs:
No clinical signs were observed during the test.
Conclusions:
The acute oral non-lethal dose in rats was greater than 2000 mg/kg.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline is specified in the report.
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD (SD) BR
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 1% methylcellulose or 0.9% NaCl
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
5 g/kg bw
No. of animals per sex per dose:
3 animals per sex per dose
Control animals:
not specified
Details on study design:
All animals were observed for clinical signs and mortality for 7 days. At the end of the observation period, all animals were sacrificed and subjected to complete necropsy.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was observed during the test.
Clinical signs:
No clinical signs were observed during the test.
Conclusions:
The acute oral non-lethal dose in rats was greater than 5000 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No mortalities, adverse effects or clinical signs were observed during the acute oral toxicity studies. Therefore, the highest doses tested were considered to the non-lethal doses and the LD50 is greater than 2000 mg/kg bw and is therefore above the dose required for classification.