Registration Dossier
Registration Dossier
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EC number: 931-534-0 | CAS number: 68439-57-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions. Only 7 days of observation period.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only 7 days observation period
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only 7 days observation period
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- EC Number:
- 931-534-0
- Cas Number:
- 68439-57-6
- Molecular formula:
- C(4+2n)H(9+4n)SO4Na C(4+2n)H(7+4n)SO4Na n = 5-6
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): α-Olefinsulfonate (4192), C14-C16-α-Olefinsulfonate, Sodium salt
- Physical state: faint yellow powder
- Analytical purity: 95% active
- Composition of test material, percentage of components: 3% Na2SO4; 2% residual oil
- Purity test date: 18 May 1994
- Lot/batch No.: E06184192 from 01 March 1994
- Expiration date of the lot/batch: 31 December 1994
- Storage condition of test material: dark at room temperature under extractor hood
- Other: pH 5 (1% in water)
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik, Dr. Karl Thomae GmbH, 88400 Biberach, SPF breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 2.8 - 3.8 kg
- Housing: individually in fully air conditioned rooms
- Diet: Altromin 2123 maintenance diet for rabbits, Altromin-GmbH, Lage/Lippe, ad libitum, and hay, ca. 15 g daily)
- Water: tap water from automatic drinking trough, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 50 ± 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened with 0.4 ml 0.9% NaCl-solution - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 to 60 min, 24, 48 and 72 hours, 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk was shaved on an area of 25 cm² with electric clippers. Only animals with intact skin were used.
- Type of wrap if used: Moistened test substance was applied to 2.5 x 2.5 cm cellulose patches covered with adhesive tape. The patch was secured to the prepared skin site and covered with a semiocclusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, substance remnants were carefully removed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize, evaluations were done 30 - 60 min and 24, 48 and 72 hours after patch removal. As effects were observed 72 hours after removal additional readings were performed after 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: fine scales observed at the end of observation period
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Remarks on result:
- other: dry rough skin after 3 and 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: dry rough skin after 2 and 3 days, fine scales with desquamation after 7 days
- Irritant / corrosive response data:
- 30 min until 72 hours after patch removal the treated skin demonstrated barely perceptible (grade 1) to well defined (grade 2) erythema and very slight (grade 1) to slight (grade 2) edema. The skin surface was dry and rought and demonstrated fine scales which were still visible in 2/3 animals after 7 days, the end of the observation period. Additionally, desquamation of fine scales was observed in 1/3 animals.
Any other information on results incl. tables
The test substance has to be classified as "Irritating to skin" (R38) according to the criteria of the DSD and as Skin Irrit. 2 (H315: Causes skin irritation) according to the criteria of the CLP regulation.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- EU Directive 67/548/EEC: Skin irrit 2, H315
Regulation (EC) No 1272/2008: Xi, R38
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