5-hydroxyiminobarbituric acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Remarks:

The study has been performed in House according to current guidelines by trained technicians. The study is commonly performed at the lab and leaves up to the validty criteria.Thus data from the study can be considered reliable.

Test material

Test material information

Constituent 1

Reference substance name:

5-hydroxyiminobarbituric acid

EC Number:

201-741-4

EC Name:

5-hydroxyiminobarbituric acid

Cas Number:

87-39-8

Molecular formula:

C4H3N3O4

IUPAC Name:

5-(hydroxyimino)-1,3-diazinane-2,4,6-trione

Test material form:

solid: particulate/powder

Details on test material:

Lot/batch No.: 201713807

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from a single donor

Control samples:

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg



NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16µl PBS


POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 µl SDS
- Concentration (if solution): 50mg/mL

Duration of treatment / exposure:

42 min +/- 2 min

Duration of post-treatment incubation (if applicable):

42h +/- 1h

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

1.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Violuric was found to reduce the cell viabilty more than 50% in the present test system and must thus be considered as an irritant. However, the present test system cannot distinguish between category 1 and 2 classification.

Executive summary:

Violuric acid has been tested for skin irritation according to OECD with the ' SkinEthic^TMReconstructed Human Epidermis kit RHE/S/17'.

The irritation potential was assessed indirectly by assessing the uptake of MTT in living cells, which results in conversion to MTT in a blue dye, which can be measured spectophotometrically and by visual assessment of the tissue after 42 min exposure to the test substance followed by 42 h post treatment period. Viability of cells exposed to violuric acid was 1% compared to control cells and thus indicates irritaion potential of the test substance.

According to the test system violuric acid should be classified as irritant, but the test system cannot distinguish between category 1 and 2 classification.

In conclusion, violuric acid was found to be irritaing in the present test system.