Registration Dossier

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:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
no

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 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:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.