Diphenyl sulphone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Justification for type of information:

The DPS dossier containsold in vivo studies, which are not allowed today. Therefore a justification needs to be added in the end point data summary. The new legal requirements (21 June 2016) require an in vitro skin irritation study.However the previous data requirements were met with an in vivo study during the dossier compilation for the 100-1000 T/Y tonnage band. Therefore there is no need to repeat the study using the alternatiuve test method.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Diphenyl sulphone

EC Number:

204-853-1

EC Name:

Diphenyl sulphone

Cas Number:

127-63-9

Molecular formula:

C12H10O2S

IUPAC Name:

(benzenesulfonyl)benzene

Details on test material:

- Name of test material (as cited in study report): Diphenylsulfon (DPS)
- Substance type: organic
- Physical state: solid, white powder
- Analytical purity: > 99%
- Purity test date: 15/05/2001
- Lot/batch No.: 1712SA
- Expiration date of the lot/batch: 15/05/2002
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark
- Other: Bulk density: 0.7 - 0.8
Stability in vehicle (water): not indicated

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: between 1.0 and 3.5 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 53.5*63*38.5 cm).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100g per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided twice a week.
- Water (e.g. ad libitum): Free acces to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+-3°c
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 h dark per day.


IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):0.5g
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressing and test substance

Number of animals:

3 animals of one sex

Details on study design:

TEST SITE
- Area of exposure: 150 square centimeters (10*15 cm²)
- % coverage:
- Type of wrap if used: metalline patch (supplier: Lohmann GmbH, Neuwied, Germany) of 2*3 cm. The patch was mounted on Micropore tape (supplier: 3M, St. Paul, Minnesota, USA), which was wrapped around the abdomen and securied with Coban elastic bandage (supplier: 3M, St. Paul, Minnesota, USA).


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin cleaned of residual test substance using water
- Time after start of exposure: four hours after the application


SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given was recorded:

ERYTHEMA AND ESCHAR FORMATION:
No erythema......................................................................................0
Very slight erythema (barely perceptible).....................................1
Well-defined erythema.....................................................................2
Moderate to severe erythema..........................................................3
Severe erythema (beet redness)*....................................................4
(* Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (=4) is given.)

OEDEMA FORMATION:
No oedema........................................................................................................................................................0
Very slight oedema (barely perceptible).......................................................................................................1
Slight oedema (edges of area well-defined by definite raising)................................................................2
Moderate oedema (raised approximately 1 millimeter)..............................................................................3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)...........4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24,48,72h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

IRRITATION: No skin irritation was caused by 4 hours exposure to DPS.
CORROSION: There was no evidence of a corrosive effect on the skin.
COLOURATION: No staining of the treated skin by the test substance was observed.
TOXICITY / MORTALITY: No symptoms of systematic toxicity were observed in the animals during the test period and no mortality occured

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), diphenylsulfon (DPS) does not have to be classified and has no obligatory labelling requirement for skin irritation.