Benzenesulfonic acid, 4-(1-methylethyl)-, potassium salt (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: Read across from another member of the category

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:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium p-cumenesulphonate

EC Number:

239-854-6

EC Name:

Sodium p-cumenesulphonate

Cas Number:

15763-76-5

Molecular formula:

C9H12O3S.Na

IUPAC Name:

sodium 4-isopropylbenzenesulfonate

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 - 10 weeks
- Weight at study initiation: 2.40 - 2.77 Kg
- Housing: individually housed in steel cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Conditioned for at least 5 days prior to study initiation. Maintained according to the recommendations contained in the "Guide for the Care and Use of Laboratory Animals", National Academy Press, 1996

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): "light controlled"

IN-LIFE DATES: From: August 7, 2007 To: August 10, 2007

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 gram
- Concentration (if solution): undiluted; test substance is 40% active ingredient
VEHICLE- Amount(s) applied (volume or weight with unit): no vehicle

Duration of treatment / exposure:

4 hours; after which excess test material was removed from the site

Observation period:

30 minutes and 24, 48 and 72 hours after patches were removed

Number of animals:

3 (females)

Details on study design:

TEST SITE
- Area of exposure: 6 sq cm
- % coverage:
- Type of wrap if used: 2 layer gauze patch covered with semiocclusive plastic overwrop held in place with Kendall Curity Standard Porous Tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess removed
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The maximum skin irritation score was 1.0 at the 4.5 hour observation.
The primary irritation score Index (4.5, 24, 48 and 72 hours) = 0.25

Other effects:

Final body weights were within expected values.

Any other information on results incl. tables

See attached table

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritant

Executive summary:

The skin irritation of Sodium p-cumenesulphonate was assessed following official guideline OECD 404, Acute Dermal Irritation/corrosion. 
The results showed no irritation, no erythema and no oedema in any animals. The test results are considered applicable for potassium p-cumenesulphonate based on the chemical similarity.