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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: Department of Transportation, Method of Testing Corrosion to Skin. Federal Register, Vol. 41, No. 118, Sept. 27, 1976, p.42572.

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

other: 49 Code of Federal Regulations, part 173, Appendix A, Dec. 31, 1991, pp. 594, 595, and 471. Part 171, Dec. 19, 1994.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-16-alkyl derivs.

EC Number:

271-528-9

EC Name:

Benzenesulfonic acid, C10-16-alkyl derivs.

Cas Number:

68584-22-5

IUPAC Name:

4-dodecylbenzenesulfonic acid

impurity 1

Reference substance name:

Benzene, C10-16-alkyl derivs.

EC Number:

272-008-4

EC Name:

Benzene, C10-16-alkyl derivs.

Cas Number:

68648-87-3

IUPAC Name:

tridecylbenzene

impurity 2

Reference substance name:

Sulphuric acid

EC Number:

231-639-5

EC Name:

Sulphuric acid

Cas Number:

7664-93-9

Molecular formula:

H2O4S

IUPAC Name:

sulfuric acid

Test material form:

liquid: viscous

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks
- Housing: The rabbits were individually housed in stainless steel cages in a temperature, humidity, and light controlled room. The rabbits were maintained according to the recommendations contained in the National Academy Press 1996: "Guide for the Care and Use of Laboratory Animals".
- Diet: Purina Rabbit Chow, ad libitum
- Acclimation period: At least three days

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL test article

Duration of treatment / exposure:

For 3 minutes (site A), 1 hour (site B) and 4 hours (site C)

Observation period:

Up to 14 days

Number of animals:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Performed by wiping .
- Time after start of exposure: At the conclusion of the contact periods.

OBSERVATION TIME POINTS
Observations for irritation, ulceration and necrosis were performed and findings recorded at the end of each contact period, again at 60 minutes for the 3 minute contact and also at 24, 48, and 72 hours following test article application for the 1 and 4 hour contacts. Additional readings were continued up to 14 days to confirm Packing Group.

SCORING SYSTEM:
- Method of calculation: Corrosion is considered to have resulted if the substances in contact with the rabbit skin, produced full thickness destruction or irreversible alteration of the tissue. Tissue destruction is considered to have occurred if. at any of the readings there is ulceration and/or necrosis. Tissue destruction would not include merely sloughing of the epidermis, erythema, oedema or fissuring. Scoring was performed according to the scoring schemes presented in Tables 1 to 3 in the "Any other information on materials and methods incl. tables" field.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Site A - 3 minutes of exposure

Basis:

mean

Remarks:

Animal #1 to #6

Time point:

other: 1 hour

Score:

0.5

Max. score:

4

Remarks on result:

other:

Remarks:

No necropsy observed

Results 2

Irritation parameter:

erythema score

Remarks:

Site B - 1 hour of exposure

Basis:

mean

Remarks:

Animal #1 to #6

Time point:

72 h

Score:

4

Max. score:

4

Remarks on result:

other:

Remarks:

Necropsy observed in 5 out of 6 animals.

Results 3

Irritation parameter:

erythema score

Remarks:

Site C - 4 hours of exposure

Basis:

mean

Remarks:

Animal #1 to #6

Time point:

72 h

Score:

4

Max. score:

4

Remarks on result:

other:

Remarks:

Necropsy observed in all animals.

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Other time points were assessed for classification purposes for corrosive chemicals.

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Other time points were assessed for classification purposes for corrosive chemicals.

Irritant / corrosive response data:

Three minute occluded contact produced minimal irritation, and necrosis was not observed in any of the six test subjects. The test material is not corrosive following a three minute contact period. One hour occluded contact produced severe irritation, and necrosis was observed in five of the six test subjects. The test material is corrosive following a one hour contact period.

Any other information on results incl. tables

Table 1. Site A, Erythema scores- Contact time: 3 minutes

ANIMAL NUMBER	3 Minutes	1 Hour
1	0	1
2	0	1
3	0	0
4	0	0
5	0	1
6	0	0

Table 2. Site B, Erythema scores- Contact time: 1 hour

ANIMAL NUMBER	1 Hour	Day 1	Day 2	Day 3
1	2	3	4	N
2	2	3	4	N
3	2	4	4	N
4	2	4	4	N
5	1	3	4	N
6	2	3	4	4

Table 3. Site C, Erythema scores - Contact time: 4 hours

ANIMAL NUMBER	4 Hours	Day 1	Day 2	Day 3
1	4	4	4	N
2	4	4	N	N
3	4	4	N	N
4	4	4	N	N
5	N	N	N	N
6	4	N	N	N

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

In accordance with D.O.T. Guidelines, Federal Register, Volume 55, No. 246, the test substance is a corrosive agent and would be classified as packing group II.

Executive summary:

The test article was tested for corrosivity in accordance with Department of Transportation Guidelines. The test article was applied at a dose of 0.5 mL to three skin sites on a clipped area of each of six albino rabbits. The three sites were designated for application of test article as follows; Site A - three minute occluded contact, Site B - one hour occluded contact, and Site C - four hour occluded contact.

Three minute occluded contact produced minimal irritation, and necrosis was not observed in any of the six test subjects. The test article is not corrosive following a three minute contact period. One hour occluded contact produced severe irritation, and necrosis was observed in five of the six test subjects. The test article is corrosive following a one hour contact period.

In accordance with D.O.T. Guidelines, Federal Register, Volume 55, No. 246, the sample is a corrosive agent and would be classified as packing group II.