Chromium (III) propionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

60 minutes exposure with 42 hour post exposure incubation

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study to GLP
Oxalate salt is seen as a suitable surrgoate for propionic acid salt; the two acids are similar and are both water soluble under the conditions of testing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dichromium trioxalate

EC Number:

250-317-5

EC Name:

Dichromium trioxalate

Cas Number:

30737-19-0

Molecular formula:

Cr2 (C2O4)3

IUPAC Name:

Dichromium trioxalate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch RGA16-5628

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

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:

Test item - single application of nominal 25 mg on top of each tissue (tissues pre-wetted with 25μl PBS)
Reference items – single application 30 μl of negative control (PBS) or positive control (SDS 5%).
Three tissues were used per condition (n=3).

Control samples:

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

25 mg applied neat to wetted surface

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1

Value:

6.3

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test item reduced the viability to less than 50% or below and should be considered as Irritant.
However, the viability was not sufficiently reduced to be considered as potentially corrosive.

Executive summary:

Valid study confirming that the criteria to classify as irritant were met.