Registration Dossier
Registration Dossier
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EC number: 406-640-0 | CAS number: 136920-07-5 KEROFLUX ES 3241
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
- EC Number:
- 406-640-0
- EC Name:
- A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
- Cas Number:
- 136920-07-5
- Molecular formula:
- C58H114N4O6 - C154H308N6O4
- IUPAC Name:
- Reaction mass of 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C12-C18)alkylacetamide and {[2-(Carboxymethyl-di(C12-C18)alkylcarbamoylmethyl-amino)-ethyl]-di(C12-C18)alkylcarbamoylmethyl-amino}-acetic acid
- Reference substance name:
- Keroflux ES 3241
- IUPAC Name:
- Keroflux ES 3241
- Details on test material:
- - Lot No.: T 75492/ST 1414/90, Part 1
- Physical state: solid, light beige; after heating at about 50°C: liquid, yellow
- Date of manufacturing: 1990-10-10
- Storage stability: at about 8°C
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, D
- Weight at study initiation: 3.44 kg (male), 3.17-3.51 kg (females)
- Housing: single in stainless steel cages with wire mesh walk floors
- Diet: KLIBA 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, CH; 130 g/ day
- Water: tap water; 250 mL/ day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping of the fur
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- Application of 0.5 ml of the test substance (cooled down to body temperature) to the test patch (2.5 cm x 2.5 cm)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3
- Details on study design:
- Clipping of the fur: at least 15 hours before the beginning of the study.
Application site: upper third of the back or flanks
Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h, 8 d and 15 d after beginning of application; scoring according to the OECD/Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: scaling observed on 1/3 animals at the 15d reading; see table below for details
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: scaling observed at the end of the observation period
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
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.
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