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Toxicological information

Acute Toxicity: dermal

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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:
2013
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

Constituent 1
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.

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
Body weight:
The body weight changes were within the expected range for this species and age of animals at the end of the study
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.