Whey, lactose-low

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

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 442E (Human Cell Line Activation Test)

GLP compliance:

yes (incl. QA statement)

Type of study:

activation of dendritic cells

Justification for non-LLNA method:

Alternative (in vitro) methods are recommended in first intention by ECHA

Test material

Test material information

Constituent 1

Reference substance name:

Whey, lactose-low

EC Number:

295-893-9

EC Name:

Whey, lactose-low

Cas Number:

92129-93-6

IUPAC Name:

Whey, lactose-low

Results and discussion

Positive control results:

In the positive control (DNCB), RFI values of both CD54 and CD86 should exceed the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%) and the cell viability should be > 50%.

1st assay:
2 μg/mL DNCB (CD 54): 268.2%
2 μg/mL DNCB (CD 86): 465.8%
3 μg/mL DNCB (CD 54): 192.0%#
3 μg/mL DNCB (CD 86): 826.1%

2nd assay:
2 μg/mL DNCB (CD 54): 230.8%
2 μg/mL DNCB (CD 86): 275.0%
3 μg/mL DNCB (CD 54): 258.9%
3 μg/mL DNCB (CD 86): 493.4%

In vitro / in chemico

Results

Results 1

Key result

Run / experiment:

other: both runs

Parameter:

other: RFI of CD86 (%)

Value:

150

Vehicle controls validity:

valid

Positive controls validity:

valid

Results 2

Key result

Run / experiment:

other: both runs

Parameter:

other: RFI of CD54 (%)

Value:

200

Vehicle controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of 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%. Except the CD54 RFI value of the positive control (3.0 μg/mL DNCB) in the first h-CLAT run did not exceed the positive criterion (CD54 ≥ 200%). However, this is considered to be acceptable since the CD54 RFI value of the positive control (2.0 μg/mL DNCB) in the first h-CLAT run exceeded the positive criteria. For details see Annex 1 and 2.

Any other information on results incl. tables

The following concentrations of the test item were tested in the main experiments (h-CLAT):

1395, 1674, 2009, 2411, 2894, 3472, 4167 and 5000 μg/mL

The test item with a log Pow of 1.1 was tested in 2 independent runs. The RFI of CD86 and CD54 was equal or greater than 150% and 200%, respectively, in all concentrations of both runs. Therefore the h-CLAT prediction is considered positive for the tested test item in this h-CLAT.

Applicant's summary and conclusion

Interpretation of results:

other: The h-CLAT prediction is considered positive for the tested test item in this h-CLAT.

Conclusions:

The test item Whey, lactose-low with a log Pow of 1.1 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).