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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: Read across from category (Hydrotropes)

Adequacy of study:

key study

Study period:

August 7 - 14, 2007

Reliability:

1 (reliable without restriction)

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 405 (Acute Eye 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

Details on test material:

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

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kuiper RAbbitry, Gary, Indiana
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 2.59-2.66 kg
- Housing: individually 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. Animals were maintained according to "Guide for the Carre 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 room"


IN-LIFE DATES: From: August 7, 2007 To: August 14, 2007

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: unexposed eye of each animal served as its own control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 gram
- Concentration (if solution): undiluted is 40% active ingredient


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle

Duration of treatment / exposure:

single dose (no washing)

Observation period (in vivo):

at 1, 24, 48 and 72 hours and at 7 days

Number of animals or in vitro replicates:

3 (males)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: fluorescein (2%) and ultraviolet light

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 hours

Score:

>= 23.33

Max. score:

27

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: total maximum score possible is 110

Irritant / corrosive response data:

The maximum irritation (noted as "moderate") occurred at 24 hours, with effects observed in the cornea, iris and conjunctiva of all three animals. The scores were noticeably lower at 48 hours and again at 72 hours. No irritation was detected at 7 days.

Other effects:

Final body weights were within expected range.

Applicant's summary and conclusion

Interpretation of results:

other: moderately irritating

Conclusions:

The test material would be classified as Toxicity Category III in accordance with OPPTS/OECD Guidelines. The test material is moderately irritating to the eye.