Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22. August - 13. October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study according to OECD guideline under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, 17. July 1992
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
August 1998
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): ASC plus
- Substance type: white, christalline powder
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: 0604
- Expiration date of the lot/batch: 12/2001
- Storage condition of test material: room temperature, dark
- Date of receipt: 23. August 2000

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: E. A. Prinzhorn, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.27 (female), 3.63 and 3.73 (male)
- Housing: individual in cages
- Diet: Harlan Teklad TLM Rabbit Maintenace Diet (ad libitum)
- Water: drinking water ad libitum
- Acclimation period: more than 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3°C
- Humidity (%): 30-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: back was clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3 patches with each containing 0.5 g of undiluted test material were applied onto different areas of the back.

Control: one untreated area on the back
Duration of treatment / exposure:
Animal No. 1:
3 min, 1 h, 4 h
Animals No 2 and 3 were additionally exposed each for 4 h because no treatment related effects were observed for animal No 1.
Observation period:
skin was examined for signs of erythema and oedema according to the classification system of guideline OECD 404 at 1, 24, 48 and 72 h after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage:
- Type of wrap if used: Gaze-patches, Semiocclusive bandage with Ypsiplast (Holthaus Medical, Remscheid-Lüttringhausen), Elastoplast (Beiersdorf), Stülpa (Beiersdorf)

- skin was examined for signs of erythema and oedema
- clinical signs were examined as well.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Remarks:
and oedema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not possible because no changes occured
Remarks on result:
other: There were no signs of redness or swelling at all time points.
Irritant / corrosive response data:
controls: score for erythema and oedema: 0 at all time points, no signs of redness or swelling.

No other toxicological symptoms were observed for treatments and controls.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
fully reliable study,
According to the results of this study: not irritating to skin.
Executive summary:

The test substance (CAS 78521-39-8) was applied to the back of 3 rabbits within a skin irritation test according to guideline OECD 404. 0.5 g of pure undiluted test material were applied in each of 3 patches in a semiocclusive way for 48 hours. Time points for observation were 1, 24, 48 and 72 hours after removal of the patch.

Scores for oedema and erythema: 0 at all time points.

No signs of redness or swelling and no other symptoms.

According to the results of this study the test material is considered as not irritating to skin.