Bis(4-chlorophenyl) sulphone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to OECD guideline with acceptable restrictions (analytical purity of the test substance not reported, occlusive dressing, only 8 days observation period)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(analytical purity of the test substance not reported, occlusive dressing, 8-days observation period)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(4-chlorophenyl) sulphone

EC Number:

201-247-9

EC Name:

Bis(4-chlorophenyl) sulphone

Cas Number:

80-07-9

Molecular formula:

C12H8Cl2O2S

IUPAC Name:

1-chloro-4-(4-chlorobenzenesulfonyl)benzene

Details on test material:

- Name of test material: 4,4'-dichlorodiphenyl sulfone (DCDPS)
- Analytical purity: not reported

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Gaukler, Offenbach, Germany
- Weight at study initiation: 2.63 kg (male), 3.42 and 2.84 kg (females)
- Housing: individual, in stainless steel cages
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, Germany; approx. 130 g/animal/day
- Water: approx. 250 mL/animal/day

ENVIRONMENTAL CONDITIONS
- Temperature: 20-26 °C
- Humidity: 50-80 %
- Photoperiod: 12 hours dark/12 hours light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved, intact and scarified

Vehicle:

water

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg
- Concentration: 80% in water

Duration of treatment / exposure:

24 hours

Observation period:

8 days

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Remaining test substance was wiped off
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24-72 hours

Score:

1.6

Max. score:

8

Remarks on result:

other: Based on results obtained for both intact and scarified skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(n=3)

Time point:

other: 24-72 hours

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days in 2/3 animals

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(female)

Time point:

other: 24-72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Intact skin

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(male)

Time point:

other: 24-72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days

Remarks on result:

other: Intact skin

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(female)

Time point:

other: 24-72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours; desquamation noted after 8 days

Remarks on result:

other: Intact skin

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

(n=3)

Time point:

other: 24-72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(n=3)

Time point:

other: 24-72 hours

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days in 3/3 animals

Remarks on result:

other: Scarified skin

Results 8

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(female)

Time point:

other: 24-72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Scarified skin

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(male)

Time point:

other: 24-72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days

Remarks on result:

other: Scarified skin

Results 10

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(female)

Time point:

other: 24-72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days

Remarks on result:

other: Scarified skin

Results 11

Irritation parameter:

edema score

Basis:

mean

Remarks:

(n=3)

Time point:

other: 24-72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days in 3/3 animals

Remarks on result:

other: Scarified skin

Results 12

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(female)

Time point:

other: 24-72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days

Remarks on result:

other: Scarified skin

Results 13

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(male)

Time point:

other: 24-72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days; desquamation noted after 8 days

Remarks on result:

other: Scarified skin

Results 14

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(female)

Time point:

other: 24-72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Scarified skin

Irritant / corrosive response data:

Slight erythema were observed at the intact skin at 24 and 72 hours. There were no edema.
At the abraded skin, slight erythema and/or slight edema were noted at 24 and 72 hours.
The primary dermal irritation index was 1.6.

Other effects:

Desquamation was noted on day 8 of the observation period in 2/3 and 3/3 application sites with intact and scarified skin, respectively.

Any other information on results incl. tables

Animals number	Intact shaved skin: Draize score after
	24 h		72 h		8 days		Mean 24-72 h
	E	O	E	O	E	O	E	O
1	1	0	1	0	0	0	1.0	0.0
2	1	0	1	0	0*	0*	1.0	0.0
3	1	0	0	0	0*	0*	0.5	0.0
Mean (3 rabbits) 24-72 h							0.83	0.0

Animals number	Scarified skin: Draize score after
	24 h		72 h		8 days		Mean 24-72 h
	E	O	E	O	E	O	E	O
1	2	1	2	1	0**	0**	2.0	1.0
2	2	1	2	1	0**	0**	2.0	1.0
3	1	0	1	0	0*	0*	1.0	0.0
Mean (3 rabbits) 24-72 h							1.67	0.67

* Desquamation; ** Severe desquamation

Applicant's summary and conclusion

Conclusions:

DCDPS is not irritating to the skin.

Executive summary:

In a skin irritation study (BASF AG, 1981), young adult Vienna White rabbits (1 male, 2 females) were dermally exposed to DCDPS (500 mg/application site; 80 % in water) for 24 hours using an occlusive dressing. The test item was applied to the intact and scarified skin of each rabbit (2.5 x 2.5 cm per application site). The rabbits were observed for 8 days post application. Scoring of the application sites was performed according to Draize at 24 and 72 hours and after 8 days.

For the intact skin, very light erythema and no oedema were observed at 24 and 72 hours. For the abraded skin, slight erythema and/or slight edema were noted at 24 and 72 hours. The primary dermal irritation index for the 24 and 72 -hours timepoints was 1.6 of max. 8. On day 8 after patch removal, desquamation was noted in 2/3 and 3/3 application sites with intact and scarified skin, respectively.

Based on the Draize scores on the intact shaved skin no significant irritation responses were observed. The severity of the observed desquamation on the intact skin was mild at the most, and due to the absence of a clear irritation reaction a relevance for classification can not be deduced.

Summarized the result of this "worst case" assessment of DCDPS (24h, occlusive application, short observation period) is, that no skin irritation potential was identified for according to Directive 67/548/EEC and Regulation 1272/2008. The use of scarified skin is not a standard method for testing dermal irritation, hence the scores obtained for scarified skin were not taken into consideration.