Registration Dossier
Registration Dossier
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EC number: 701-164-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-***
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid
- EC Number:
- 701-164-2
- IUPAC Name:
- Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid
- Test material form:
- liquid: viscous
- Details on test material:
- Chemical registery number : 701-164-2
Chemical name : Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid
Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 10 µL (26.3 µL/cm2) of the test material was applied to the epidermis surface
- Duration of treatment / exposure:
- exposure period of 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 Hour post-exposure incubation period
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 94.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was classified as non-irritant.
- Executive summary:
The relative mean viability of the test item treated tissues was 94.6% after the 15-Minute exposure period and 42-Hours post-exposure incubation period. The test item was classified as non-irritant.
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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