Registration Dossier
Registration Dossier
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EC number: 610-962-9 | CAS number: 5311-05-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1996
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Reference Type:
- other: Draft Renewal Assessment Report under Regulation (EC) 1107/2009
- Title:
- Draft Renewal Assessment Report under Regulation (EC) 1107/2009 - Tritosulfuron
- Year:
- 2 018
- Bibliographic source:
- Draft Renewal Assessment Report under Regulation (EC) 1107/2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The current study was conduced according to a draft version of OECD 423 (1996).
According to the currently valid OECD 423 (2002), the age of the animals used should be between 8 and 12 weeks. However, since this parameter was not explicitly mentioned in the previous version of OECD 423 (1996), the animals of the present study are declared as “young adults”. Nevertheless, based on the initial body weight and the known strain (Wistar) of the rats used, their age can be estimated to be 5 - 8 weeks for males (body weight of 166 - 173 g) and 7 - 11 weeks for females (body weight of 166 - 191 g). Therefore, this discrepancy is considered to be a minor deviation that can be compensated for by further data of the current study and thus, does not compromise the outcome of the study.
Additionally, fixed dose levels, 5, 50, 300 and 2000 mg/kg bw should be applied according to OECD 423 (2002). However, since the previous version of OECD 423 (1996) required fixed doses of 25, 200 and 2000 mg/kg bw, the mid dose tested was 200 mg/kg bw instead of 300 mg/kg bw. - GLP compliance:
- yes
Results and discussion
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Due to the deviaton from the dose level according to OECD 423 this study cannot be used for the classification.
- Executive summary:
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