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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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
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
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
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
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
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
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
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
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
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
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
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
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.