Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs.

Skin irritation / corrosion

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

EC Number:

287-494-3

EC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

Cas Number:

85536-14-7

Molecular formula:

None available - not a single isomer - see remarks

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

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 or test system 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

Results

Results 1

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

Results 2

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.