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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
August 22- October 13, 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Physical state: solid
- Analytical purity: 92.5% octyl sulphate
- Lot/batch No.:12076LW115
- Expiration date of the lot/batch: March 06, 2013
- Storage condition of test material: Ambient (RT); Store frost-free; avoid temperatures > 30°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Approx. 4 - 8 months
- Weight at study initiation: 4.41 kg –5.01 kg
- Housing: Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2. Fully air-conditioned rooms.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization for at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
The solid test item was minimally moistened with a suitable amount of highly deionized water to guarantee skin contact immediately before test-item application
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of undiluted test item

VEHICLE
Minimally moistened with highly deionized water
Duration of treatment / exposure:
4h
Observation period:
Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The test item was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animal with equal erythema score of 3
Time point:
other: mean of 24-72h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of 24-72h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of 24-72h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of 24-72h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritant / corrosive response data:
The following test item-related clinical observations were recorded during the course of the study:

• Well-defined to moderate erythema (grade 2 to 3)
• Very slight to severe edema (grade 1 to 4)
• Scaling
• Severe scaling
• Incrustations
• Eczema like skin lesions
• Erythema and edema beyond the application site
• Bloody, yellowish discolored incrustations
• Yellowish discoloration of the application site
• Plaque-like incrustations

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Testitem shows a skin irritating potential under the test conditions chosen.
Executive summary:

The potential of TI to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing one additional animal per step up to a maximum number of three animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off.

The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals until day 14.

 

The following test item-related clinical observations were recorded during the course of the study:

  • Well-defined to moderate erythema (grade 2 to 3)
  • Very slight to severe edema (grade 1 to 4)
  • Scaling
  • Severe scaling
  • Incrustations
  • Eczema like skin lesions
  • Erythema and edema beyond the application site
  • Bloody, yellowish discolored incrustations
  • Yellowish discoloration of the application site
  • Plaque-like incrustations

The cutaneous reactions were not reversible in all animals during the course of the study.

Mean scores over 24, 48 and 72 hours for each animal were 3.0, 3.0 and 3.0 for erythema and 2.0, 3.3 and 3.0 for edema.

 

Considering the described cutaneous reactions as well as the average score for irritation, TI shows a skin irritating potential under the test conditions chosen.