Benzene, C10-13-alkyl derivs.

Skin irritation / corrosion

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

Test material information

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

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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.