Registration Dossier
Registration Dossier
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EC number: 610-141-5 | CAS number: 437717-43-6
Endpoint summary
Administrative data
Description of key information
Sulfotriazinonsäure is non toxic after single oral exposure (LD50 cut-off, rat: > 2500 mg/kg bw).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: 8-12 weeks
- Mean weight at study initiation: 259 g (males) or 179 g (females)
- Housing: in groups of 3 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol 400
- Details on oral exposure:
- - Application volume: 10 mL/kg bw
- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes - Statistics:
- none (limit test)
- Sex:
- male/female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died after administration of 2000 mg/kg bw.
- Clinical signs:
- other: After administration of 2000 mg/kg bw the motility was decreased in females and diarrhea was observed in both genders.
- Gross pathology:
- No gross pathological findings were observed.
- Other findings:
- none
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
The acute oral toxicity of Sulfotriazinonsäure was low with a LD50 exceeding 2500 mg/kg bw in rats (cut-off value) according to OECD TG 423.
A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, effects on body weight gain or gross pathological findings. After administration of 2000 mg/kg bw the motility was decreased in females and diarrhea was observed in both genders.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and is of high quality (Klimisch score=1)
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
The acute oral toxicity of Sulfotriazinonsäure was low with a LD50 exceeding 2500 mg/kg bw in rats (cut-off value) according to OECD TG 423 (Krötlinger, 2000). A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, effects on body weight gain or gross pathological findings. After administration of 2000 mg/kg bw the motility was decreased in females and diarrhea was observed in both genders.
Justification for selection of acute toxicity – oral endpoint
Only one study available
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.
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