Registration Dossier
Registration Dossier
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EC number: 243-869-3 | CAS number: 20544-37-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,9-dibenzyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- EC Number:
- 243-869-3
- EC Name:
- 3,9-dibenzyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- Cas Number:
- 20544-37-0
- Molecular formula:
- C19H22O6P2
- IUPAC Name:
- 3,9-dibenzyl-2,4,8,10-tetraoxa-3λ⁵,9λ⁵-diphosphaspiro[5.5]undecane-3,9-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot No. of test material: 44216018
- Expiration date of the lot/batch: 31-0ct-2019
- Purity test date: 99.9 %
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: lnVivos Pte Ltd, 9 Perahu Road, Lim Chu Kang, Singapore 718793
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 218, 248, 202 g
- Housing: OptiMICE Caging Systems for rats
- Diet (e.g. ad libitum): Altromin Maintenance Diet #1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days before the test was conducted.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 30 - 70
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal
- % coverage: 10
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of exposure period, residual test substance was removed, the exposure area was cleaned carefully with water.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 436, 496 and 404 mg
- Constant concentration used: yes, 2000 mg/kg bw
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied: test substance was moistened with 1.0 ml of water for injection and applied uniformly over the shaved area - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- 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: Observation during the first 30 minutes, 1, 2 and 6 hours, and daily thereafter to 14 days. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test substance. The body weight of each animal was measured once a week.
- Necropsy of survivors performed: yes, on the termination day gross necropsy was conducted on each animal.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death was observed on all the animals during dosing and observation period.
- Clinical signs:
- other: No toxicity effect was observed on all the animals during dosing and observation period.
- Gross pathology:
- No abnormality was observed on all the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of this study and based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) for acute dermal toxicity hazard categories, the test item 3,9-dibenzyl-2,4,8, 10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide is considered as unclassified, the LD50 value of the test item is more than 2000 mg/kg body weight.
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