2-amino-5-chlorobenzophenone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Remarks:

h-CLAT

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 442E

Deviations:

yes

Principles of method if other than guideline:

In vitro Human Cell Line Activation Test (h-CLAT) is performed to assess the dendritic cell activation potential (third key event of a skin sensitization AOP)

GLP compliance:

yes (incl. QA statement)

Type of study:

activation of dendritic cells

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-5-chlorobenzophenone

EC Number:

211-949-7

EC Name:

2-amino-5-chlorobenzophenone

Cas Number:

719-59-5

Molecular formula:

C13H10ClNO

IUPAC Name:

(2-amino-5-chlorophenyl)(phenyl)methanone

Test material form:

solid: particulate/powder

In vitro test system

Details on the study design:

The following concentrations of the test item were tested in the main experiments (h-CLAT): 10, 12, 15, 17, 21, 25, 30 and 36 μg/mL
Medium control : Culture medium
Positive control : 2,4-dinitrochlorobenzene (DNCB)
Test system : THP-1 cells (Human monocytic leukemia cell line)
Solvant conrol : Dimethyl sulfoxide (DMSO)

Results and discussion

Positive control results:

In the DMSO control, RFI values compared to the medium control of both CD54 and CD86 did not exceed the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%). The RFI values of the positive controls (DNCB) for CD54 and CD86 exceeded the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%) and the cell viability was >50%.

In vitro / in chemico

Results

Results 1

Key result

Run / experiment:

other: Max concentration - Mean of 2 runs

Parameter:

other: RFI (%) - CD86 antibody

Value:

241.75

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Key result

Run / experiment:

other: Max concentration - Mean of 2 runs

Parameter:

other: RFI (%) - CD54 antibody

Value:

151.7

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The test item with a log Pow of 3.16 ± 0.05 was tested in 2 independent runs. The RFI of CD86 was equal or greater than 150% in at least one concentration of the first run and the RFI of CD86 and CD54 was equal or greater than 150% and 200%, respectively, in at least one concentration of the second run. Therefore the h-CLAT prediction is considered positive for the tested test item in this h-CLAT.
did not exceed the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%). The RFI values of the positive controls (DNCB) for CD54 and CD86 exceeded the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%) and the cell viability was >50%. For details see Annex 1 and 2.
This human cell line activation test can be used as part of a testing battery (including e.g. DPRA (Direct Peptide Reactivity Assay), ARE-Nrf2 luciferase test method) based on the OECD adverse outcome pathway for the assessment of the skin sensitisation potential of chemicals.

Applicant's summary and conclusion

Interpretation of results:

other: This human cell line activation test can be used as part of a testing battery

Conclusions:

This in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the dendritic cell activation potential (third key event of a skin sensitization AOP) of D4223 accodring to OECD 442E guideline. The test item D4223 with a log Pow of 4.1 activated THP-1 cells under the test conditions of this study. Therefore the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).

Executive summary:

This in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the dendritic cell activation potential (third key event of a skin sensitization AOP) of D4223 accodring to OECD 442E guideline. The test item D4223 with a log Pow of 4.1 activated THP-1 cells under the test conditions of this study. Therefore the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).