Registration Dossier
Registration Dossier
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EC number: 221-088-9 | CAS number: 3001-98-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-22 till 2016-04-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The results of the study allow the calculation of the oral LD50 of the test item and permit the test item to be ranked according to most classification systems currently in use.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- EC Number:
- 221-088-9
- EC Name:
- 3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- Cas Number:
- 3001-98-7
- Molecular formula:
- C7H14O6P2
- IUPAC Name:
- 3,9-dimethyl-2,4,8,10-tetraoxa-3λ⁵,9λ⁵-diphosphaspiro[5.5]undecane-3,9-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- AFLAMMIT® PCO 962
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000, 5000 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg: 1 female
5000 mg/kg: 3 female - Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: All animals were symptom free during the entire study.
- Gross pathology:
- No external or internal macroscopic findings were noted in study animals at necropsy on
Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item
AFLAMMIT PCO 962 was found to be greater than 5000 mg/kg bw in female
Crl:WI rats.
The study result triggers the following classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 6) 2015: unclassified
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