Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-767-7 | CAS number: 2893-78-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 28 1984 - July 19 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented guideline study but not performed to GLP. The chlorinated isocyanurates (sodium dichloroisocyanurate and sodium dichloroisocyanurate dihydrate) produce free available chlorine, in the formof 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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium dichloroisocyanurate dihydrate
- IUPAC Name:
- Sodium dichloroisocyanurate dihydrate
- Reference substance name:
- 1,3-dichloro-1,3,5-triazine-2,4,6(1H,3H,5H)-trione sodium salt dihydrate
- Cas Number:
- 51580-86-0
- Molecular formula:
- C3Cl2N3O3.2H2O.Na
- IUPAC Name:
- 1,3-dichloro-1,3,5-triazine-2,4,6(1H,3H,5H)-trione sodium salt dihydrate
- Details on test material:
- - Name of test material (as cited in study report): Dichloroisocyanuric acid, sodium salt dihydrate
- Physical state: White granular material
- Analytical purity: 100% assumed for dosage calculations
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania
- Housing: Elevated wire-mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 7 days
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- Dermal responses were graded and scored at 30-60 minutes, 24, 48, 72 and 96 hours and on days 7, 10, 14 and 21 days after the patches were removed.
- Number of animals:
- 3 per sex (total of 6)
- Details on study design:
- TEST SITE
- Type of wrap if used: Non absorbant binder
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours following application, the binders and patches were removed and exposure sites were wiped
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.7
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Irritant / corrosive response data:
- Very slight to moderate erythema was observed in all sites at 30 to 60 minutes after patch removal through 24 hours: persisting in two sites through 72 hours and in two sites through 96 hours. Very slight to slight edema was observed in five sites at 30-60 minutes through 24 hours: persisting through 48 hours in one site. Other dermal effects included thickening, blanching, necrosis, epidermal scaling, raw areas, and compound adhered to the skin. All irritation cleared by 21 days.
Any other information on results incl. tables
Table 1: Individual dermal irritation scores (erythema)
Animal no |
Sex |
Site |
Erythema score |
||||||||
Mins |
Hours |
Days |
|||||||||
30-60 |
24 |
48 |
72 |
96 |
7 |
10 |
14 |
21 |
|||
E353960 |
Male |
I |
2 |
3 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
E353961 |
Male |
I |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
E353962 |
Male |
I |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
E36000 |
Female |
I |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
E36001 |
Female |
I |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
E36002 |
Female |
I |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
Mean: |
1.7 |
1.7 |
1.2 |
1.2 |
0.3 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Table 2: Individual dermal irritation scores (edema)
Animal no |
Sex |
Site |
Edema score |
||||||||
Mins |
Hours |
Days |
|||||||||
30-60 |
24 |
48 |
72 |
96 |
7 |
10 |
14 |
21 |
|||
E353960 |
Male |
I |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
E353961 |
Male |
I |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
E353962 |
Male |
I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
E36000 |
Female |
I |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
E36001 |
Female |
I |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
E36002 |
Female |
I |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean: |
1.3 |
1.0 |
0.2 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Table 3: Other dermal effects
Other observations |
||||||||
Mins |
Hours |
Days |
||||||
30-60 |
24 |
48 |
72 |
96 |
7 |
10 |
14 |
21 |
X |
RB |
RB |
RBT |
NT |
NT |
S |
S |
- |
X |
X |
T |
T |
- |
- |
S |
S |
- |
X |
X |
- |
- |
- |
S |
S |
S |
- |
X |
RT |
RT |
RT |
T |
N |
S |
S |
- |
X |
RT |
RT |
RT |
NT |
N |
ST |
ST |
- |
X |
RT |
RT |
RT |
T |
N |
S |
- |
- |
B = Blanching
S= Epidermal scaling
T = Thickening
N - Necrosis
R = Raw areas
X - Compound adhered to skin
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sodium dichloroisocyanurate dihydrate is considered to be corrosive to skin due to the visible necrosis that was observed on the skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
