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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:
key study
Study period:
1977-12-06 to 1977-12-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to Guideline without GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive dressing, 24 and 72 h scoring missing.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Constituent 1
Reference substance name:
Sulfuric acid, mono-C10-16-alkyl esters, sodium salts
EC Number:
271-557-7
EC Name:
Sulfuric acid, mono-C10-16-alkyl esters, sodium salts
Cas Number:
68585-47-7
IUPAC Name:
sodium tetradecyl sulfate
Details on test material:
- Name of test material (as cited in study report): KAS paste (Potassium alkyl sulphate) or B0010-01
- Molecular formula (if other than submission substance): Not available
- Molecular weight (if other than submission substance): 318.451
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: Not available
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: See below
- Isomers composition: Not available
- Purity test date: Not available
- Lot/batch No.: 763-I'dale
- Expiration date of the lot/batch: See below
- Stability under test conditions: Not available
- Storage condition of test material: 21°C or less
- Other: None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: King's wheel rabbitry
- Age at study initiation: Not available
- Weight at study initiation: > 2 kg
- Housing: Not available
- Diet (e.g. ad libitum): Not available
- Water (e.g. ad libitum): Not available
- Acclimation period: Not available


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not available
- Humidity (%): Not available
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): Not available


IN-LIFE DATES: From: 1977-12-06 To: 1977-12-08

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gm
- Concentration (if solution): Undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
4 h
Observation period:
4 and 52 hours post patch application (0 and 48 hrs after patch removal)
Number of animals:
6 animals
Details on study design:
TEST SITE
- Area of exposure: Back of animals
- % coverage: Test substance applied using 1 x 1 inch multi-ply gauze patch
- Type of wrap if used: Impervious material like rubberized cloth


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Erythema and eschar scoring from 0-4 with 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema (beet redness) to slight eschar formation (injuries in depth).
Edema scoring from 0-4 with 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well defined by definite raising), 3 = moderate edema (raised approximately 1mm), 4 = severe edema (raised more than 1 mm nd extending beyond the area of exposure).
Primary irritation index: 0-2 = mild, 2-5 = moderately irritating, 5-6 = moderately to severely irritating, 6-8 = severely irritating

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks:
48 h after patch removal
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0.7
Max. score:
4
Reversibility:
not reversible
Remarks:
48 h after patch removal
Irritant / corrosive response data:
For intact skin site: PII at 4 hours - 1.83, PII at 52 hours - 3.17
Other effects:
None reported

Any other information on results incl. tables

 Animal No.

 Skin site

    Degree of erythema after---- [Observation time]

    Degree of edema after---- [Observation time]

 

 

 4 hours

 52 hours

 4 hours

 52 hours

 

 Intact

 

 

 

 

 136

 

 1

 3*

 0

 1*

 

 

    

    

 124

 

 2

 3*

 0

 1*

 

 

    

    

 148

 

 2

 2*

 0

 0

 

 

    

    

 146

 

 2

 3*

 0

 1*

 

 

    

    

 156

 

 2

 1*

 0

 0*

 

 

    

    

 151    2  3*  0  1*
       

Note: * Erythema and edema extending beyond and surrounding each test site (2 -5 cm) was noticed.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information R38 Criteria used for interpretation of results: EU
Conclusions:
KAS paste/ Potassium alkyl sulfate (44% potassium alkyl sulfate) is classified as a non-corrosive and skin irritant according to EU classification.
Executive summary:

0.5 gm of undiluted 44% Potassium alkyl sulfate as a paste was applied to intact test sites on each of the six New Zealand albino rabbits using 1 x 1 inch multi-ply gauze patch. Test sites were wrapped with impervious material such as rubberized cloth for 4 hours. After 4 hours of exposure, the patch was removed and the test sites were examined and washed with water. The sites were again examined for erythema and edema at 52 hours post application.

At 4 hours post patch application (0 hrs post patch removal) very slight to well-defined erythema was observed at the intact skin site of all the animals. No edema was observed in any of the animals. At 52 hours post patch application (48 hrs post patch removal) all animals showed very slight to moderate to severe erythema and no to very slight edema. Erythema and edema extended beyond each test site (2 -5 cm) at the 52 hour grading.

Thus, KAS paste/ Potassium alkyl sulfate (44% Potassium alkyl sulfate) is classified as a non-corrosive and moderate skin irritant according to OECD GHS classification.