D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.

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:

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:

D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.

EC Number:

940-284-1

Cas Number:

1591782-62-5

Molecular formula:

C15H31NO6 C17H35NO6

IUPAC Name:

D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.

Test material form:

other: solid

Details on test material:

Chemical Name: D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.
CAS No.: 85316-98-9 and 85261-20-7 (related to main C-chain lengths of the active material)
Physical State: solid, powder
Colour: colourless
Molecular Weight: 321.42 – 349.47 g/mol
pH: 8-10 (20°C, 10 g/l)
Storage Conditions: room temperature

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 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.

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:

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 labeling. Based on the results, Glucamide 810 is not subject for classification and labelling requirements with regard to skin irritation according UN GHS and EU CLP ("No Category").