Rhodium trinitrate

Endpoint summary

Description of key information

In three in vitro membrane barrier tests (CORROSITEX™ Assays), conducted according to OECD Test Guideline 435 and to GLP, rhodium trinitrate displayed mean breakthrough times of 18.4, 4.7 and 6.5 minutes when tested as a solid (Lehmeier, 2013a), in aqueous solution (Lehmeier, 2013b) and in solution (Lehmeier, 2014), respectively, and was considered corrosive to the skin.

 

No relevant eye or respiratory tract irritation data were identified. However, such testing is not considered appropriate asrhodium trinitrateis classified as corrosive to the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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)

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.

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).

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

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.

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No relevant human irritation/corrosion data were identified.

 

In three good quality GLP studies, conducted according to OECD Test Guideline 435, the potential of rhodium trinitrate as a solid, aqueous solution or solution to induce skin corrosion was assessed in the "in vitro membrane barrier test (CORROSITEX™ Assay)". The test items were 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 trinitrate (solid) to activate the CDS was 18.4 minutes (mean of 4 replicates). The test substance is therefore classified as "corrosive" sub category 1B, according to EU CLP criteria (EC 1272/2008), as the mean time to activate the CDS was between 3-30 minutes (category 2) (Lehmeier, 2013a).

 

For rhodium trinitrate aqueous solution, the mean time required to activate the CDS was 4.7 minutes (mean of 4 replicates). The test substance is therefore classified as "corrosive" sub category 1B, according to EU CLP criteria (EC 1272/2008), as the mean time to activate the CDS was between 3-60 minutes (category 1) (Lehmeier, 2013b).

 

Finally, the mean time required for rhodium trinitrate solution to activate the CDS was 6.5 minutes (mean of 4 replicates). The test substance is therefore classified as "corrosive" sub category 1B, according to EU CLP criteria (EC 1272/2008), as the mean time to activate the CDS was between 3-60 minutes (category 1) (Lehmeier, 2014).

 

No eye or respiratory tract data were identified. However, eye irritation testing is not considered appropriate as rhodium trinitrateis classified as corrosive to the skin.

Justification for classification or non-classification

Based on the results of the available reliable in vitro skin corrosion studies, rhodium trinitrateshould be classified as corrosive to the skin (category 1B) according to EU CLP criteria (EC 1272/2008). Substances that are corrosive to the skin are considered as leading to serious damage to the eyes. Consequently, rhodium trinitrate should be classified for eye effects in Category 1 according to EU CLP criteria (EC 1272/2008).