Registration Dossier
Registration Dossier
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EC number: 940-422-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: in vitro
- 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:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (Skin Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
- Reference substance name:
- Glucamide CC
- IUPAC Name:
- Glucamide CC
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- EC Number:
- 940-422-0
- Cas Number:
- 1591783-13-9
- Molecular formula:
- C15H31NO6 (C8 derivative) C17H35NO6 (C10 derivative) C19H39NO6 (C12 derivative) C21H43NO6 (C14 derivative) C23H47NO6 (C16 derivative) C25H51NO6 (C18 derivative) C25H49NO6 (C18 unsatd. derivative)
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- Test material form:
- other: solid
- Details on test material:
- Chemical Name:D-Glucitol, 1-deoxy-1-(methylamino)-, N-coco acyl derivs.
CAS No.:1591783-13-9
Colour:white to slightly yellowish
Storage Conditions:at room temperature
Constituent 1
Constituent 2
Test system
- Amount / concentration applied:
- Solids: 10 mg + 5 µL aqua dest.
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 +/- 1 h
- Details on study design:
- The test was performed on EpiSkin, an organotypic reconstructed three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test item, the negative control (10µL DPBS) and the positive control (10µL 5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with DPBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 570 nm.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Tissue viability
- Time point:
- other: 42 hours p.a.
- Remarks on result:
- other: According to Article 13 of the REACH Regulation (EC) 1907/2006, information on the endpoint `skin irritation` has been generated using OECD TG 439 `In vitro skin irritation: Reconstructed human epidermis test methode`. Thus no standard scores are given.
Any other information on results incl. tables
The test item showed no direct MTT reducing capability and no colouring potential.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is classified as "non-irritant" (No Category).
- Executive summary:
In the in vitro skin irritation test using the EpiSkin human epidermis model 10 mg test item + 5 µL A. dest. were applied topically for 15 minutes. After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay.
The mean relative tissue viability (% negative control) was > 50%.
The test item is therefore classified as "non-irritant" (UN GHS: No Category).
This study is classified as acceptable:
OD550 of the blank is < 0.1.
Mean OD550 of the three negative control tissues is >= 0.6 and <= 1.5.
Mean relative tissue viability of the three positive contol tissues is <= 40%.
Standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is < 18%.
This study satisfies the requirement for Test Guideline OECD 439 for in vitro skin irritation and is relevant for classification and labelling. Based on the results, Glucamide CC is not subject for classification and labelling requirements with regard to skin irritation according to UN GHS and EU CLP ("No Category").
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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