1,2,3-Propanetricarboxylic acid, 2-hydroxy-, chromium(3+) salt (1:1)

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
Acetate salt is seen as a suitable surrgoate for citrate; the two acids are similar and are both water soluble under the conditions of testing
Citric acid is not classified as irritant to skin.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

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:

Chromium acetate

EC Number:

241-562-9

EC Name:

Chromium acetate

Cas Number:

17593-70-3

Molecular formula:

3Cr, < 3(C2H4O2) < 1(OH)

IUPAC Name:

Chromium III hydroxyacetate

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:

59

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The test item did not reduce the viability to 50% or below and should be considered as non-Irritant.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not reduce the viability to 50% or below and should be considered as non-Irritant.

Executive summary:

Valid study confirming that the criteria to classify as irritant were not met. However, there was some reduction in viability suggesting a weak irritation potential