Registration Dossier

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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