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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
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
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

Constituent 1
Chemical structure
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
Chemical structure
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.

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