Registration Dossier
Registration Dossier
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EC number: 278-855-6 | CAS number: 78169-20-7
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: comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: BASF internal standard protocol
- Principles of method if other than guideline:
- The fur of 2 rabbits was clipped and the unchanged test substance was applicated using a soaked test patch (2.5 x 2.5 cm). The patch was applicated onto the back of the animals. After an occlusive exposure period of 1, 5 and 15 minutes as well as 20 hours the application area was washed with Lutrol/water (1:1). Furthermore the ears were wrapped for 20 hours with a patch soaked with the test substance. Skin effects were documentated 24 hours and 8 days after the removal of the test patches.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts)
- EC Number:
- 278-855-6
- EC Name:
- Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts)
- Cas Number:
- 78169-20-7
- Molecular formula:
- unspecified
- IUPAC Name:
- Reaction product of dodecene-1 with mercaptoethanol, ethyleneoxide and sulfuric acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- ca. 1 g
- Duration of treatment / exposure:
- 1 min, 5 min, 15 min, 20 h
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- The test substance was washed off with 50% Lutrol.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- back skin
- Time point:
- other: 1/5/15 min exposure, reading after 24 h
- Score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: slight erythema 24 h after occlusive exposure for 1, 5 and 15 minutes, respectively
- Irritation parameter:
- other: irritation score
- Basis:
- mean
- Remarks:
- back skin
- Time point:
- other: 1/5/15 min exposure, reading after 8 days
- Score:
- 1
- Reversibility:
- other: symptoms on the last study day
- Remarks on result:
- other: severe irritation 8 days after occlusive exposure for 1, 5, and 15 minutes, respectively
- Irritation parameter:
- other: necrosis score
- Basis:
- mean
- Remarks:
- back skin
- Time point:
- other: 20 h exposure, reading after 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: marked necrosis (full thickness) 24 h after an 20 h of occlusive exposure
- Irritation parameter:
- other: necrosis score
- Basis:
- mean
- Remarks:
- back skin
- Time point:
- other: 20 h exposure, reading after 8 days
- Score:
- 2
- Reversibility:
- other: symptoms on last study day
- Remarks on result:
- other: marked necrosis (full thickness) 8 days after an 20 h occlusive exposure
Any other information on results incl. tables
24 h after the exposure for 1, 5, and 15 minutes, respectively, the skin on the back showed a slight erythema which emerged as severe irritation 8 days after the application. Treatment of the back skin for 20 h caused marked (full thickness) necrosis with dermatorrhagia after 24 h and 8 days. The ear showed severe irritation 24 h after the 20 h exposure and marked (full thickness) necrosis 8 days after the application.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The test item caused sever irritation 8 days after an exposure of 1, 5, and 15 minutes, respectively, and skin corrosion after an exposure for 20 h.
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