Registration Dossier
Registration Dossier
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EC number: 237-249-1 | CAS number: 13708-85-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium phosphonate
- EC Number:
- 237-249-1
- EC Name:
- Disodium phosphonate
- Cas Number:
- 13708-85-5
- Molecular formula:
- Na2HPO3
- IUPAC Name:
- disodium phosphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium phosphonate (BRÜGGOLEN H10)
- Substance type: inorganic
- Physical state: solid
- Analytical purity: 95%
- Lot/batch No.: 07090801
- Expiration date of the lot/batch: 08.09.2009
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER, France
- Age at study initiation: 6 weeks (males), 8 weeks (females)
- Weight at study initiation: 234 g -246 g (males) and 201 g - 224 g (females)
- Housing: individual cages
- Diet (e.g. ad libitum): freely
- Water (e.g. ad libitum): freely
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 0, 2, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the test and the observation period.
- Clinical signs:
- other: No clinical signs were observed during the test and the observation period.
- Gross pathology:
- No findings in the examined organs and tissues.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item Disodium phosphonate (BRÜGGOLEN H10) ist higher than 2,000 mg/kg bw by dermal route in the rat.
- Executive summary:
The LD50 of the test item Disodium phosphonate (BRÜGGOLEN H10) ist higher than 2,000 mg/kg bw by dermal route in the rat.
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