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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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:
other: 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:
other: 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.