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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:
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

Constituent 1
Chemical structure
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.

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