Benzenesulfonic acid, mono-C10-13-alkyl derivs., potassium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 18, 1986 to March 31, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

EC Number:

270-115-0

Cas Number:

68411-30-3

IUPAC Name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Purity/Activity: 47%
Average alkyl chain length = C11.2
Appearance: clear yellow liquid stored at ambient temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Froxfield Rabbits and Buckmasters
Age at study initiation: 12-14 weeks
Weight at study initiation: 2.7-3.3 kg
Housing: individually housed in metal cages, identified by aluminum ear tags
Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
Water (e.g. ad libitum): tap water, ad libitum
Acclimation: yes
Temperature (°C): 19
Humidity (%): 30-70
Air changes (per hr): 19
Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

3

Details on study design:

Hair was clipped from a 10 x 10 area of the dorsal-lumbar region. Test substance was applied under a gauze pad, and then covered with elastic adhesive dressing. Examination of the treated skin was made approximately 30 min after removal of the patch and daily through 14 days. Grading and scoring of the dermal reactions were performed using the standard numerical scoring system.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

2.17

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritant / corrosive response data:

Well defined to moderate skin reactions were observed in all three animals following removal of the bandages. Desquamation of the stratum corneum were observed in all three animals. The reaction in all three animals gradually ameliorated from Days 5, 10 and 11, respectively, and had resolved completely in one animal by Day 12.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the study conditions, the test substance was considered to be irritant to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the substance

according to OECD Guideline 404. Clipped skin of three rabbits was exposed to 0.5 mL of the test substance for 4 h. The test substance was covered with an occlusive dressing and removed by washing 4 h later. Animals were examined at 30 min after removal of the dressing, and daily thereafter for 14 d. Grading and scoring of the dermal reactions were performed using the standard numerical scoring system. Irritation was noted in all animals at the first observation (score of 2). Symptoms worsened, and desquamation, necrosis, and hyperkeratinization were noted by Day 4. Symptoms resolved in one animal by Day 12, but in the other two animals, symptoms were observed throughout the study. The primary dermal irritation index was determined to be 2.17. Under the study conditions, the substance was considered to be irritating to rabbit skin (Liggett, 1986a).