C.I. Solvent Red 119

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2017 - November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Version / remarks:

resp. OECD 439

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

C.I. Solvent Red 119

EC Number:

602-676-8

Cas Number:

12237-27-3

Molecular formula:

C32H22N10O8Cr

IUPAC Name:

C.I. Solvent Red 119

impurity 1

Reference substance name:

Unknown impurities

Cas Number:

not available

IUPAC Name:

Unknown impurities

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid: particulate/powder

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Reconstructed human Epidermis (RhE) Test

Value:

ca. 109.3

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item Solvent Red 119 is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was increased to 109.3%.
This value is above the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability criterion
of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of
the test system.
Variation within replicates was within the accepted range for negative control, positive control
and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.

Executive summary:

Three tissues of the human skin model EpiDermTM were treated with Solvent Red 119 for

60 minutes.

The test item was applied directly to each tissue and spread to match the tissue size

(0.63 cm2; as indicated by the supplier).

DPBS-buffer was used as negative control, 5% SDS solution was used as positive control.

After treatment with the negative control, the absorbance values were within the required

acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.8. The positive control showed

clear irritating effects. The mean value of relative tissue viability was reduced to 3.0% (required:

 20%).

Variation within the tissue replicates of negative control, positive control and test item was

acceptable (required: ≤ 18%).

After the treatment with the test item, the mean value of relative tissue viability was increased

to 109.3 % in comparison to the negative control. This value is above the threshold

for skin irritation potential (50%). Substances that induce values above the threshold of

50% are considered non-irritant to skin.

Therefore, Solvent Red 119 is considered non-irritant to skin in the Reconstructed human

Epidermis (RhE) Test Method.