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Diss Factsheets

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:
1986-04-17 to 1986-06-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(4-isopropoxyphenylsulfonyl)phenol
EC Number:
405-520-5
EC Name:
4-(4-isopropoxyphenylsulfonyl)phenol
Cas Number:
95235-30-6
Molecular formula:
C15H16SO4
IUPAC Name:
4-[4-(propan-2-yloxy)benzenesulfonyl]phenol
Details on test material:
- Name of test material (as cited in study report): D - 8
- Molecular formula: C15 H16 O4 S;
- Molecular weight: 292.4;
- Physical state: white powder;
- Analytical purity: > 99.5 %;
- Purity test date: not stated;
- Lot/batch No.: Not stated;
- Expiration date of the lot/batch: not stated;
- Stability under test conditions: stable at ambient temperature and conditions;
- Storage condition of test material: store in a cool dry place, protected from direct sunlight;

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits; Petersfield, Hampshire; England;
- Age at study initiation: approximately 11 to 12 weeks;
- Weight at study initiation: 2.4 to 2.7 kg;
- Housing: individually in metal cages with perforated floors;
- Diet: SDS Standard Rabbit Diet ad libitum;
- Water: tap water ad libitum;
- Acclimation period: not stated;

ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: approximately 19 air changes/min;
- Photoperiod: 12 hours light/12 hours dark;


Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of test material
Duration of treatment / exposure:
4 hours
Observation period:
4 Days
Number of animals:
six males
Details on study design:
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0.5 g amount of D-8 was applied under a 2.5 cm square gauze pad moistened with 0.5 mL of distilled water to one intact skin site of each animal.
Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period.
The animals were not restrained during the exposure period and were returned to their cages.
At the end of the exposure period, the semi-occlusieve dressing and gauze pad were removed and the treatment site was washed using distilled water to remove any residual test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
1991
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
1992
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
1993
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
1994
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
1995
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
1996
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
1991
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
1992
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
1993
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
1994
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
1995
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
1996
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of irritation observed.
Other effects:
No other effects observed.

Any other information on results incl. tables

No dermal irritation was observed in any of the six rabbits.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
D-8 was tested for skin irritation in rabbits according to EU Test Guideline B.4. No skin irritation was observed in any of the six rabbits. D-8 can be regarded as non-irritant to the skin.
Executive summary:

D-8 was tested for skin irritation in rabbits with an occlusive test. The substance was applied on the intact skin for four hours and subsequently removed by rinsing with water. The animals were observed for erythema and oedema on the following 4 days. No signs of dermal irritation was observed in any of the six animals. Therefore, D-8 was considered non-irritant to the skin.