Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24,48,72h
Score:
0
Max. score:
4
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.