Benzene, bis(1-methylethyl)-, sulfonated, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

August 7 - 10, 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2007 GLP 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 cumene sulfonate

IUPAC Name:

sodium cumene sulfonate

Constituent 2

Reference substance name:

Sodium cumenesulphonate

EC Number:

248-983-7

EC Name:

Sodium cumenesulphonate

Cas Number:

28348-53-0

IUPAC Name:

sodium 2-phenylpropane-2-sulfonate

Details on test material:

- Name of test material (as cited in study report): STEPANATE SCS-40-E (confirmed by sponsor as sodium cumene sulfonate (40%)
- Molecular formula (if other than submission substance): no data
- Physical state: clear liquid
- Analytical purity: 40%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 40% active
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: no data
- Other:

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): 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

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

>= 0.25

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

The maximum skin irritation score was 1.0 at the 4.5 hour observation.

Other effects:

Final body weights were within expected values.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Not irritating