Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 931-974-3 | CAS number: 1231880-35-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
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:
- 1 977
- 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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
