1,3,5,7-Tetraazatricyclo[3.3.1.13,7]decane, mononitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

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:

3,5,7-triaza-1-azoniatricyclo[3.3.1.13,7]decane nitrate

EC Number:

687-538-5

Cas Number:

18423-20-6

Molecular formula:

C6H13N5O3

IUPAC Name:

3,5,7-triaza-1-azoniatricyclo[3.3.1.13,7]decane nitrate

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: 0.38 cm2 RhE of normal human keratinocytes

Cell source:

foreskin from multiple donors

Justification for test system used:

EpiSkinTM is one out of the four validated test methods using commercially available RhE models included in the OECD TG Nº431. EpiSkinTM can be used for regulatory purposes for distinguishing between corrosive and non-corrosive substances and can moreover be used to support sub-categorisation of corrosive substances.

Details on test system:

Reconstructed Human Epidermis (RhE; EpiSkin-SM): This is a three-dimensional human skin model comprising a reconstructed epidermis with a
functional stratum corneum. Differentiated and stratified epidermis model comprises the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Remarks on result:

other: The percentage of viability was determined to be 103.9%, 104.0% and 92.2%at the 3min, 1h and 4h time points, respectively, using living RhE inserts.

Remarks:

Therefore, the compound was classified as non-corrosive following the criteria of OECD 431, since the viability was ≥35% after 4 hours of exposure.

Other effects / acceptance of results:

The run carried out with the living RhE inserts met the predefined acceptance criteria, i.e., i) mean ODNC of the RhE inserts treated with the negative control was within the range 0.6-1.5 at 570 nm ± 30 nm; ii) the relative viability for the positive control at the 4h exposure time point expressed as % of the negative control was ≤20%; and iii) in the range of 20 -100% viability and for ODs≥0.3, the difference in the viability between the two RhE replicates did not exceed 30%.
For the test item Hexamine nitrate, the percentage of viability was determined to be 103.9%, 104.0% and 92.2% at the 3min, 1h and 4h time points, respectively, using living RhE inserts. Therefore, the compound can be classified as non-corrosive following the criteria of OECD 431, since the viability was ≥35% after 4 hours of exposure.

Applicant's summary and conclusion

Interpretation of results:

other:

Conclusions:

Taking into account the results obtained in the current study, it is concluded that, under the assayed experimental conditions and according to the OECD guideline for the Testing of Chemicals Nº. 431, the test item Hexamine Nitrate can be categorised as Non-Corrosive according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.