Clorofene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Oct - 02 Nov 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1992

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

directly 3 animals tested instead of 1 animal in the initial test and 2 in the confirmatory test, 21 days instead of 14 days observation period, first scoring 30 min instead of 60 min after patch removal

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

adopted in 1998

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF, 59 NohSan No. 4200

Version / remarks:

adopted in 1985

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Clorofene

EC Number:

204-385-8

EC Name:

Clorofene

Cas Number:

120-32-1

Molecular formula:

C13H11ClO

IUPAC Name:

clorofene

Details on test material:

Batch number: K0019

Test animals

Species:

rabbit

Strain:

other: Hra:(NZW)SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., Kalamazoo, Michigan
- Age at study initiation: approximately 16 weeks
- Weight at study initiation: 2.382 - 2.479 g
- Housing: individually in stainless steel cages
- Diet: measured amount of high-fiber rabbit diet (#5326, Purina Mills, Inc.)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with approximately 0.4 mL distilled water

Duration of treatment / exposure:

4 h

Observation period:

21 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- % coverage: 100
- Type of wrap if used: 8-ply gauze patch secured with paper tape, loosely overwrapped with Saran Wrap®, and secured with Elastoplast® tape

REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were washed using water and disposable paper towels. Any residual test substance was removed from the test sitesas thoroughly as possible.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
4, 24, 48, 72, 96 hours and 7, 14, 21 days (The degree of erythema and edema was read approximately 30 min after removal of the test substance. This time point is recorded as the 4 h score.)

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

2.78

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Beside erythema and edema reactions blanching, desquamation, necrotic appearing areas, eschar, scar-like tissue and exfoliation were observed. Comparing these findings between day 7, 14 and 21 a clear tendency to reversibility and recovery of the skin is apparent, with only scar-like tissue remaining at the end.

Any other information on results incl. tables

Table 1: Results of skin irritation study

Animal number	Hour					Day
	4*	24	48	72	96	7	14	21
Erythema
1	2^b	2^b	3^b	4^n	4^n	4^x	1^d,s	0^s
2	2^b	2^b	2^b	4^n	4^n	4^x	0^s	0^s
3	2^b	2^b	2^b	4^n	4^n	4^x	0^s	0^s
Edema
1	4	4	4	4	4	3	0	0
2	4	4	4	4	4	2	0	0
3	4	4	4	4	4	4	0	0

* 30 min after removal of the test substance

b = blanching

d = desquamation

e = eschar

n = necrotic appearing area

s = scar-like tissue

x = exfoliation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

CLP: Skin Irrit. 2, H315