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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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Laboratory study in experienced testing laboratory.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Male and female white New Zealand rabbits weight between 4 and 5.6 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.
Number of animals:
6 (3 male, 3 female)
Details on study design:
The shaved treated area (about 6 m2) was covered with gauze and covered by polyethylene film for the first 4 hours, at which time the test area was rinsed with warm water. Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: Mean of 1, 24, 48 and 72 hours.
Score:
5.25
Max. score:
6
Reversibility:
not reversible
Remarks on result:
other: highly irritating
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 hr readings
Score:
5.33
Max. score:
8
Reversibility:
not fully reversible within: 14 days
Other effects:
Significant reddening effects were observed at all times and were persistent. Bloody wounds and scar formation were observed through at least observation day 9.

Any other information on results incl. tables

Results of Skin Irritation Study in Rabbits

Observation

Endpoint

Male

11499

Male

11887

Male

11901

Female

11580

Female

11658

Female

11802

1 hr

Erythema

4 X

4 X

4 X

4 X

4 X

4 X

1 hr

Edema

1

1

1

1

1

1

24 hrs

Erythema

4 X

4 X

4 X

4 X

4 X

4 X

24 hrs

Edema

1

1

1

1

1

1

48 hrs

Erythema

4 X

4 X

4 X

4 X *

4 X

4 X *

48 hrs

Edema

1

1

1

1

1

1

72 hrs

Erythema

4 *

4 *

4 X *

4 X *

4 *

4 *

72 hrs

Edema

2

2

2

2

2

2

6 days

Erythema

4 +

4 *

4 *

4 * -

4 +

4 + -

6 days

Edema

2

2

2

2

2

2

9 days

Erythema

W

W

W

+

W

+

9 days

Edema

C N

C N

N

 

N

W

14 days

Erythema

N

N

N

N

N

N

14 days

Edema

N

N

N

N

N

N

X ¿ Necrosis in application area bordered by swelling

* - Application area hardened

+ - Wavy crust

- - Application area paper-like

W ¿ Bloody wounds

C - Crust formation

N ¿ Scar formation

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Result: Highly irritating
Executive summary:

The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the test substance and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits. The test substance is considered corrosive to skin according to OECD GHS guidelines.