Rhodium trinitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13-14 May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Conducted according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Rhodium(III) nitrate hydrate

EC Number:

603-842-2

Cas Number:

13465-43-5

Molecular formula:

H4N3O11Rh

IUPAC Name:

Rhodium(III) nitrate hydrate

Constituent 2

Reference substance name:

Rhodium trinitrate hydrate

IUPAC Name:

Rhodium trinitrate hydrate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): rhodium trinitrate hydrate - solid
- Physical state: Brown solid
- Analytical purity: Not specified.
- Impurities (identity and concentrations): Not specified.
- Composition of test material, percentage of components: Rhodium content 35.28% w/w
- Isomers composition: Not specified.
- Purity test date: Not specified.
- Lot/batch No.: 10211
- Expiration date of the lot/batch: 31 December 2014
- Stability under test conditions: Not specified.
- Storage condition of test material: Room temperature.

Test animals

Species:

other: Not applicable.

Strain:

other: Not applicable.

Details on test animals or test system and environmental conditions:

The CORROSITEX™ Assay is a standardized, quantitative in vitro test for skin corrosivity and has been validated by the ECVAM for testing acids, bases and their derivatives.

The test was performed on a synthetic macromolecular bio-barrier membrane resting on top of a chemical detection system (CDS). The BIOBARRIER was prepared at least 2 hours prior to tests. BIOBARRIER diluent and matrix powder were combined and heated to 68 deg C under smooth agitation. After complete dissolution, the solution was allowed to sit for 5 minutes. 200 µl of the BIOBARRIER were pipetted into each membrane disc, set on the tray and kept in the cold (2-8 deg C) for at least 2 hours.

Test system

Type of coverage:

other: Not applicable.

Preparation of test site:

other: Not applicable.

Vehicle:

unchanged (no vehicle)

Controls:

other: Negative control: citric acid (10% aq.); positive controls: nitric acid (69%), phosphoric acid (85%)

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

Up to 4 hours.

Observation period:

The test system was observed until a reaction was detected (or for a total of 4 hours).

Number of animals:

Not applicable.

The test was performed on a total of eight BIOBARRIERS (four BIOBARRIERS for the test item).

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: CORROSITEX time (minutes)

Run / experiment:

mean of 4 replicates

Value:

18.36

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Qualification/categorisation test:

The test substance was compatible with the CORROSITEX™ test system. As the sample was intensely coloured, any colour-change reaction in the categorisation tubes was indistinct. Based on pH measurement the test substance was assigned to Category 1.

 

Positive and negative control test substances:

The reaction times of positive controls nitric acid and phosphoric acid were 1.40 and 16 minutes, respectively. The reaction time of the negative control was 83 minutes. The acceptance criteria for the control substances were therefore fulfilled.

 

CORROSITEX™ Assay:

The mean time of the test substance to activate the CDS was 18.36 minutes.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

In an in vitro membrane barrier test (CORROSITEX™ Assay) conducted according to OECD guidelines and to GLP, rhodium(III) trinitrate hydrate (solid) displayed a mean breakthrough time of 18.36 minutes. The test substance is classified as "corrosive" sub category 1B, according to UN GHS criteria, as the mean time to activate the CDS was between 3-60 minutes (category 1).

Executive summary:

In a good quality GLP study, conducted according to OECD test guideline 435, the potential of rhodium(III) trinitrate hydrate (solid) to induce skin corrosion was assessed in the "in vitro membrane barrier test (CORROSITEX™ Assay)".

The test item was placed on top of a BIOBARRIER membrane which was sat on a chemical detection system (CDS) in a vial. Corrosivity is determined on the ability (measured by the time taken) of a chemical to break through the barrier and subsequently activate the underlying CDS (as seen by a colour or consistency change). The mean time required for rhodium(III) trinitrate hydrate (solid) to activate the CDS was 18.36 minutes (mean of 4 replicates).

The test substance is therefore classified as "corrosive" sub category 1B, according to UN GHS criteria, as the mean time to activate the CDS was between 3 -60 minutes (category 1).