Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 28 1984 - July 19 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well documented guideline study The chlorinated isocyanurates (sodium dichloroisocyanurate and sodium dichloroisocyanurate dihydrate) produce free available chlorine, in the form of hypochlorous acid (HOCl) as they dissolve in water. As the equilibria involve all of the possible chlorinated isocyanurates, the toxicity of sodium dichloroisocyanurate (NaDCC) and sodium dichloroisocyanurate dihydrate (NaDCC.2H2O) will be virtually equivalent at the same available chlorine concentration. The parent compound for all chlorinated isocyanurates is isocyanuric acid (cyanuric acid). All of the chlorinated isocyanurates are essentially equivalent, once they are dissolved in water at the low concentrations at which they are used. Therefore read across from sodium dichloroisocyanurate dihydrate to troclosene sodium is considered justified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dichloroisocyanuric acid, sodium salt, dihydrate
- Physical state: White granules
- Analytical purity: A value of 100% active ingredient was assumed for dosage calculation

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan, USA
- Weight at study initiation: Male initial body weights ranged from 225.6 to 275.8 g, Female initial body weights ranged from 227.8 to 267.0 g.
- Housing: Stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Minimum of one week

Administration / exposure

Vehicle:
other: acetone
Details on dermal exposure:
TEST MATERIAL- Amount applied: 12.25 mL/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All of the rats were observed for mortality and signs of toxic and pharmalogic effects immediately after dosing, at one and four hours postdose, and once daily thereafter for 14 days. Individual body weights were recorded prior to treatment, on day 7 and at death or termination.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
The test material was applied to the skin of each rat at levles of 500, 1000, 2500 and 5000 mg/kg bw. No deaths occurred during the study. All rats appeared normal at 0, 1 and 4 hours postdose and on day 4. One male was noted as being slightly depressed on days 1, 2 and 3.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occured during the study
Clinical signs:
All rats appeared normal at zero and one hour postdose. Slight depression was noted in all rats at four hours postdose and on days 1 and 2; persisting in one or more rats to day 7. All rats appeared normal by day 8.
Body weight:
Most rats gained weight from initiation through termination

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium dichloroisocyanurate dihydrate is not harmful by dermal exposure