D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C18-C18 (unsaturated) acyl] derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU Method B.46 (Skin Irritation)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

(6E)-N-[(2R,3S,4S,5S)-6-hydroxy-2,3,4,5-tetramethylhexyl]-N-methyloctadec-6-enamide; N-[(2R,3S,4S,5S)-6-hydroxy-2,3,4,5-tetramethylhexyl]-N-methyloctadecanamide

EC Number:

940-373-5

Cas Number:

1591782-99-8

Molecular formula:

C25H49NO6 (C18 unsatd.) C25H51NO6 (C18 satd.)

IUPAC Name:

(6E)-N-[(2R,3S,4S,5S)-6-hydroxy-2,3,4,5-tetramethylhexyl]-N-methyloctadec-6-enamide; N-[(2R,3S,4S,5S)-6-hydroxy-2,3,4,5-tetramethylhexyl]-N-methyloctadecanamide

Test material form:

other: Waxy solid

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 PBS) 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 PBS 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 550 nm.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: mean relative tissue viability

Value:

>= 50

Remarks on result:

other:

Remarks:

Basis: other: mean tissue viability of negative control tissue. Time point: 15 minutes treatment followed by 42 h post-incubation. Reversibility: other: not measured in test system. Remarks: non-irritant, no category (EU CLP and UN GHS). (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: mean relative tissue viability

Value:

<= 50

Remarks on result:

other:

Remarks:

Basis: other: mean tissue viability of negative control tissue. Time point: 15 minute treatment followed by 42 hour post-incubation. Reversibility: other: not measured in test system. Remarks: irritant, category 2 (EU CLP and UN GHS). (migrated information)

In vivo

Other effects:

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:

The skin irritant potential of the test substance (active content 80.4%) was investigated using the EPISKIN-Standard Model (EPISKIN-SM^TM), a reconstituted three-dimensional human epidermis model as a replacement for the Draize Skin Irritation Test (OECD 404). The test compound was applied topically to the EPISKIN-SM tissue [10 mg test item + 5 µL A. dest.] for 15 minutes followed by a 42 hour post incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with PBS. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was >50% after 15 minutes treatment and 42 hour post incubation. The controls confirmed the validity of the study. C18/18 unsatd.-Glucamide therefore classified as non-irritant in accordance with UN GHS and EU CLP "No Category".