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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:
15 Jun 1992 to 22 Jun 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Benzene, mono-C10-14-alkyl derivs.
EC Number:
270-486-9
EC Name:
Benzene, mono-C10-14-alkyl derivs.
Cas Number:
68442-69-3
IUPAC Name:
dodecylbenzene
Constituent 2
Chemical structure
Reference substance name:
Dodecylbenzene
EC Number:
204-591-8
EC Name:
Dodecylbenzene
Cas Number:
123-01-3
Molecular formula:
C18H30
IUPAC Name:
4-[dodecan-(2 to 6)-yl] benzene

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: stainless steel cages
- Diet: pellet complete diet
- Water: Purified water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 15 Jun 1992 To 22 Jun 1992

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Concentration: 100%
Duration of treatment / exposure:
4 hours
Observation period:
0, 24, 48, and 72 hours, and 5 and 7 days after removal of the patches.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm gauze pads secured by thin bands of adhesive wrap, then covered with rubberized cloth.

SCORING SYSTEM
- Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0.62
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.667
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: #2, #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: #5, #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Erythema (maximum score of 4) was seen in all animals at the 24 hour observation. In 3 of the animals, the erythema persisted throughout the experiment, and was not fully resolved by the end of the experiment on day 7. Oedema was seen in one animal at the 24 hour observation only.

Any other information on results incl. tables

Table 1: Results of Skin Irritation Study

Time after patch removal

Animal

Erythema

1

2

3

4

5

6

Mean

1 hr

0

0

0

0

0

0

0.00

24 hrs

2

1

2

1

1

1

1.33

48 hrs

2

1

1

1

1

1

1.17

72 hrs

1

1

1

1

1

1

1.00

5 days

1

1

1

1

1

1

1.00

7 days

0

0

1

0

1

1

0.50

Oedema

1 hr

0

0

0

0

0

0

0.00

24 hrs

1

0

0

0

0

0

0.17

48 hrs

0

0

0

0

0

0

0.00

72 hrs

0

0

0

0

0

0

0.00

5 days

0

0

0

0

0

0

0.00

7 days

0

0

0

0

0

0

0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance caused only mild irritation, however, symptoms were not fully resolved by the end of the experiment.
Executive summary:

This study examined the potential of the test substance to cause skin irritation. Six rabbits were exposed to undiluted test substance on shaved skin for 4 hours. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 hours after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hour observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of oedema (score of 1). There were no signs of oedema in any animal at the 48 hour observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.

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