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EC number: 813-845-2 | CAS number: 13780-04-6
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013, January
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
Test material
- Reference substance name:
- Potassium Phosphonate KH2PO3/K2HPO3
- IUPAC Name:
- Potassium Phosphonate KH2PO3/K2HPO3
- Details on test material:
- Batch number :20111216-014Expiry date :16 December 2013Storage at RTC :Room temperatureCertificate of analysis:Supplied by the Sponsor and presented in Addendum ITest item characterisation :Not undertaken at the testing facility. The determination of the identity, strength, purity, composition, stability and method of synthesis and/or derivation of the test item was the responsibility of the SponsorSample archiving:Retained within RTC archives for a period of 10 years prior to disposal.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age and weight range :6 to 8 weeks old, 176 to 200 grams(at order)Supplier :Charles River Italia S.p.A., Calco (Lecco), ItalyBreeder :Charles River Italia S.p.A., Calco (Lecco), ItalyDate of arrival :17 January 2013Weight range at arrival:201 to 206 grams Acclimatisation period:At least 5 daysVeterinary health check:After arrivalCagingNo. of animals/cage:Individually caged (both during acclimatisation and study)Housing :Clear polysulphone H-Temp solid bottomed cages measuring 35.5x23.5x19 cm (during acclimatisation) an d 42.5x26.6x18.5 cm (during the study) with nesting material provided into suitable bedding bagsCage control :Daily inspected and changed as necessary (at least 3 times/week)Water and dietWater :Drinking water supplied to each cage via a water bottleWater supply :Ad libitumDiet :4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)Diet supply :Ad libitum throughout the study Records of analyses of water and diet are kept on file at RTC. Components present in the drinking water or diet are not at a level likely to interfere with the purpose or conduct of the study.Housing conditions (parameters set)Room lighting: :Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours Air changes: :Approximately 15 to 20 air changes per hourTemperature range::22°C ± 2°C Relative humidity range::55% ± 15%Actual conditions were monitored, recorded and records retained. No relevant deviations occurred
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- Frequency of treatment:Once only, on the day of dosing (Day 1).Treatment area preparation:On the day before dosing (Day –1).A single area was clipped free of hair (by an electric clipper equipped with a suitable blade) on the dorsal surfaces of the trunk of each animal, (approximately 10% of body surface).Care was taken to avoid damage to the skin.Dose calculation:Aliquots were weighed according to the body weight of each animal measured prior to dosing and corrected for purity (50%).
- Duration of exposure:
- Exposure time :24 hoursWashing procedure:After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Doses:
- 5000 mg/Kg bw
- No. of animals per sex per dose:
- A single group of 5 male and 5 female animals was dosed at a level of 5000 mg/kg
- Details on study design:
- In life observationsMortality and morbidity:Twice daily.Clinical signs :-Day of dosing (on dosing, approximately 1, 2 and 4 hours after dosing). -Daily thereafter (14 days).Body weight :Allocation (Day -1), Days 1, 8 and 15.Terminal studiesTermination :Day 15.Euthanasia method:Carbon dioxide narcosis.Necropsy procedure:Necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the treatment site).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred and no clinical signs were observed in male or female animals following treatment
- Gross pathology:
- No abnormalities were found at necropsy examination performed on all animals at termination of the study
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD0 > 5000 mg/kg bw LD50 > 5000 mg/kg bw
- Executive summary:
The acute toxicityof KH2PO3/K2HPO3was investigated following dermal administration of a single dose to the rat at 5000 mg/kg.
No mortality occurred following dosing and no signs of toxicity were observed.
These results indicate that the test item, KH2PO3/K2HPO3, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 5000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 5000 mg/kg.
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