DL-2-aminopropan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

study performed before guideline was adopted

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)

Version / remarks:

study run before adoption of guideline

GLP compliance:

no

Remarks:

Close to GLP: Report signed by lead scientist, study director and technical reviewer, and includes all information and raw data.

Type of study:

ARE-Nrf2 luciferase KeratinoSens™ test method

Test material

Test material information

1

Reference substance name:

DL-2-aminopropan-1-ol

EC Number:

228-207-3

EC Name:

DL-2-aminopropan-1-ol

Cas Number:

6168-72-5

Molecular formula:

C3H9NO

IUPAC Name:

2-aminopropan-1-ol

In vitro test system

Details of test system:

Keratinoses transgenic cell line [442D]

Details on the study design:

12 test concentrations from 0.98 to 2000 µM

Vehicle / solvent control:

DMSO

Positive control:

cinnamic aldehyde [442D]

Results and discussion

Positive control results:

Keratinocytes exposed to CA exhibited dose dependent increase in luciferase activity on for each of the three replicates conducted on different days. The average EC1.5 (12.84 μM), maximum luciferase induction (4.39 fold) and cytotoxicity for CA were within the assay acceptable range. Similarly, average background variability for the three replicates was less than 9%, which was within the assay acceptance range. Based on these observations, all three replicates of the assay were considered acceptable.

In vitro / in chemico

Results

Key result

Group:

test chemical

Parameter:

EC 1.5 [442D]

Remarks:

not determined: <1.5-fold luciferase induction at all test concentrations

Cell viability:

>90% at all test concentrations

Remarks on result:

no indication of skin sensitisation

Outcome of the prediction model:

negative [in vitro/in chemico]

Other effects / acceptance of results:

CA (positive control) was considered positive when the luciferase induction by CA was
statistically significant (by t-test) and above the threshold of 1.5 fold induction in at least
one dose level and cell viability at that dose was greater than 70%.

Maximum luciferase induction (Imax) and EC1.5 (test material concentration at which
luciferase induction is greater than 1.5 fold) was calculated for CA. The assay was
considered acceptable only if at least one of the two following criteria were fulfilled:
• Average luciferase induction in the three replicates for CA at 64 μM between 2 and 8.
• The EC1.5 was between 7.5 μM and 30 μM.

The average variability in the 6 solvent control wells of each of the three parallel test plates was calculated. The assay was considered acceptable only when the variability was below 20%.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

DL-Alaninol was evaluated for skin sensitization potential using the KeratinoSensTM assay. The assay uses a human keratinocyte cell line (HaCaT) in which activation of the Nrf2-ARE pathway is quantified via a luciferase reporter gene assay to assess chemical reactivity which is equated to sensitization potential. The test chemical was tested at twelve concentrations ranging from 1 to 2000 μM. A test chemical is considered positive for reactivity and sensitization potential when it induces luciferase activity greater than 1.5 fold with less than 30% cytotoxicity when compared to the solvent control.
In all independent replicates, the positive control compound, cinnamic aldehyde, was positive demonstrating appropriate assay conduct.

DL-alaninol was negative for reactivity in the KeratinoSensTM assay and is considered to lack skin sensitization potential.