Registration Dossier
Registration Dossier
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EC number: 221-088-9 | CAS number: 3001-98-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-17 till 2016-03-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- 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:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: The test item was administered as a single dose without using any vehicle, but sufficient water was added to dampen the material to ensure good contact with the skin at the treatment.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred after a 24-hour dermal exposure of AFLAMMIT PCO 962
administered at 2000 mg/kg bw to Crl:WI male and female rats followed by a 14-day
observation period. - Clinical signs:
- other: Each rat was symptom-free during the entire study. Local sign was not noted in any of the study animals.
- Gross pathology:
- No external or internal macroscopic findings were noted at a dose level of
2000 mg/kg bw at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of AFLAMMIT PCO 962 after a single dermal
administration was found to be greater than 2000 mg/kg bw in male and female
Crl:WI rats.
Each rat was symptom-free during the entire study. There was no evidence for adverse effcet.
The study result triggers no classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 6) 2015: Unclassified
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