Chromium triformate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 mintues and 60 minutes exposure post exposure incubation

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Chromium triformate

EC Number:

248-230-2

EC Name:

Chromium triformate

Cas Number:

27115-36-2

Molecular formula:

Cr(CHO2)3

IUPAC Name:

chromium triformate

Test material form:

solid: particulate/powder

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Epidermis Model EpiDermTM (MatTek)

Details on animal used as source of test system:

Epidermis Model EpiDermTM (MatTek)

Justification for test system used:

This in-vitro model is considered a suitable substitute for live animals

Vehicle:

unchanged (no vehicle)

Details on test system:

The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 ul applied neat to tissue

Duration of treatment / exposure:

3 and 60 minutes

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Remarks:

% colour corrected viability

Run / experiment:

3 minute exposure

Value:

92.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Remarks:

% colour corrected viability

Run / experiment:

60 minute exposure

Value:

87.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

The mean optical density (OD) of the negative control of 2 tissues was 1.410 (3 minute exposure) or 1.369 (1-hour exposure) and was well within the acceptable range of ≥ 0.8 to ≤ 2.8. The viability of cells treated with the positive reference item 8 N KOH were 6.6% (3 minute exposure) and 6.4% (1-hour exposure) of the negative control and, hence well below the 15% cut-off value at the 1-hour exposure.

The difference of viability between the two tissue replicates (at 20 - 100% viability) was below the limit of acceptance of 30%. Hence, all acceptance criteria were fulfilled.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item failed ro reduce the viability to less than 80% or below and need not be considered as Irritant.

Executive summary:

Chromium-III-Formate was applied topically as solid test item to the model skin surface, which was moistened with sterile deionised water. Sterile deionised water was used as the negative control.8 N KOH was used as the positive reference item. The test item and the reference items were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour.

In comparison to the negative controls, the mean viability of cells exposed to the test item(% colour corrected viability) was 92.7% after a 3-minute exposure period and 87.3% after a 1‑hour exposure and hence, the 3-minute and the1-hour exposure values were above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of ≥50% and ≥15%, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.