Sulfuric acid, mono-C9-12-alkyl esters, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

August 22 - October 13, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium octyl sulphate

EC Number:

205-535-5

EC Name:

Sodium octyl sulphate

Cas Number:

142-31-4

Molecular formula:

C8H18O4S.Na

IUPAC Name:

sodium octyl sulfate

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 or test system 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 applicationENVIRONMENTAL 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 itemVEHICLEMinimally 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 AGREMOVAL 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: 4hSCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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:

Category 2 (irritant) based on GHS criteria

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 0.5 g 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.