Registration Dossier
Registration Dossier
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EC number: 929-305-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed to GLP following methods current in 2014 Validity criteria met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2-aminoethyl)(2-{[(2E)-3-methoxy-2-methyl-3-(octylsulfanyl)prop-2-en-1-yl]amino}ethyl)amine; 11-methoxy-12-methyl-3-(prop-1-en-2-yl)-2-oxa-4,7,10,14,17-pentaazanonadecan-19-amine; 2-methyl-3-(octylsulfanyl)-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; 3-({2-[(2-aminoethyl)amino]ethyl}amino)-2-methyl-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; N-{2-[(2-aminoethyl)amino]ethyl}-2-methyl-3-(octylsulfanyl)propanamide
- EC Number:
- 929-305-5
- IUPAC Name:
- (2-aminoethyl)(2-{[(2E)-3-methoxy-2-methyl-3-(octylsulfanyl)prop-2-en-1-yl]amino}ethyl)amine; 11-methoxy-12-methyl-3-(prop-1-en-2-yl)-2-oxa-4,7,10,14,17-pentaazanonadecan-19-amine; 2-methyl-3-(octylsulfanyl)-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; 3-({2-[(2-aminoethyl)amino]ethyl}amino)-2-methyl-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; N-{2-[(2-aminoethyl)amino]ethyl}-2-methyl-3-(octylsulfanyl)propanamide
- Test material form:
- liquid: viscous
- Details on test material:
- Batch : 5040-57
Amber viscous liquid
Stated purity > 99%
Constituent 1
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Relative mean tissue viability
- Value:
- ca. 93
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes exposure, 42 hour observation. (migrated information)
In vivo
- Irritant / corrosive response data:
- Exposure period 15 minutes, followed by 42 hour observation; no adverse effect in relation to control
Three replicates - viability range 81.3 % - 99.7% - Other effects:
- No other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results suggest no significant irritancy to skin through direct tissue effects by in-vitro assessment.
This does not necessarily preclude minor dermal effects on live skin, such as mild discomfort and redness (erythema) - Executive summary:
The results suggest that the test substance does not need classification as irritating to skin.
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