Rhodium chloride (RhCl3), hydrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11-14 March 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP. It should be noted that this record was produced using an English translation of the study report that was written in German.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rhodium (III) chloride hydrate

IUPAC Name:

Rhodium (III) chloride hydrate

Constituent 2

Reference substance name:

20765-98-4, 13465-43-5

IUPAC Name:

20765-98-4, 13465-43-5

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Rhodium (III) chloride hydrate
- Substance type: No data
- Physical state: Dark red crystals
- Analytical purity: 99.5% (38.3% Rh)
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: Ir, 0.005%; Ag, 0.002%; Cu 0.001%; Ca, 0.005%; Mg, 0.002%; Si, 0.003%
- Isomers composition: Not applicable
- Purity test date: 18 February 1986
- Lot/batch No.: 27461
- Expiration date of the lot/batch: No data
- Stability under test conditions: According to information of the sponsor, the test substance was stable throughout the experimental period
- Storage condition of test material: Room temperature
- Other: Soluble in water and ethanol

Test animals

Species:

rabbit

Strain:

other: White russian (albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 6-7 Months
- Weight at study initiation: 2.2-2.5 kg
- Housing: Individually housed in ASTA Model stainless steel cages
- Diet (e.g. ad libitum): Standard diet ad libitum (ssniff K “special diet for rabbits” supplied by ssniff Spezialfutter GmbH, D-4770 Soest)
- Water (e.g. ad libitum): Water was provided ad libitum in drinking water quality of the Stadtwerke Bielefeld
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 10
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): Moistened with 0.4 mL water
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

Duration of treatment / exposure:

4 hours

Observation period:

3 days (observations at 1, 24, 48 and 72 hrs after removal of the patch)

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Test item was applied to shaved skin on the back of the rabbit, between the shoulder blade and the sacrum.
- % coverage: No data
- Type of wrap if used: The site of application was covered with approx 6.25 cm2 of a linen cloth which adhered to a synthetic film glue. A bandage (Acrylastic, No. 2408, width 8 cm) was wrapped several times around the trunk to provide a complete occlusion.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: Not applicable

SCORING SYSTEM: Erythema (and eschar) formation and oedema formation were assessed qualitatively and quantitatively on the skin of 3 rabbits using the Draize method, 1, 24, 48 and 72 hr after removal of the patch. The cutaneous irritation index at the four time points was determined separately for erythema (and eschar) formation and oedema formation, based on the arithmetical mean values of the individual grades. The irritation index was graded in a modified method according to Gilman et al:

Irritation index Evaluation
0.0-0.5 non-irritant
0.6-3.0 slightly irritant
3.1-5.0 moderately irritant
5.1-8.0 severely irritant

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours post application

Score:

ca. 0

Max. score:

8

Reversibility:

other: Not applicable

Remarks on result:

other: No signs of irritation were apparent in any animal during the observation period

Irritant / corrosive response data:

There were no signs of irritation observed during the observation period

Other effects:

No systemic toxic effects were seen in the animals after application of the test material and the general condition of the animals was not affected.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a guideline study, to GLP, no irritation potential was observed when rhodium (III) chloride hydrate was applied (under occlusion for 4 hr) to the shaved, intact skin of three male rabbits.

Executive summary:

In an OECD Test Guideline 404 study, conducted according to GLP, rhodium (III) chloride hydrate (0.5 g, moistened) was applied (occluded) to the shaved, intact skin of three male White Russian rabbits. After 4 hr, the dressings were removed and the skin sites quantitatively and qualitatively assessed for signs of irritation (oedema and erythema/eschar) and corrosion at 1, 24, 48 and 72 hr.

 

No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the 72 hr observation period. The primary irrational index was therefore 0, andrhodium (III) chloride hydratewas therefore considered non-irritant in this test. There was no evidence of systemic toxic effects after application of the test material and no deleterious effects to the general condition of the animals.

 

No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.