Carbonylhydrotris(triphenylphosphine)rhodium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not stated

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The humidity went down to 30% “for a short period; this deviation was without any influence on the results of the study”. Also, the patch was occluded, rather than semi-occluded.

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:

Carbonylhydrotris(triphenylphosphine)rhodium

EC Number:

241-230-3

EC Name:

Carbonylhydrotris(triphenylphosphine)rhodium

Cas Number:

17185-29-4

Molecular formula:

C55H46OP3Rh

IUPAC Name:

carbonylhydrotris(triphenylphosphine)rhodium

Details on test material:

- Name of test material (as cited in study report): Carbonylhydridotris(triphenylphosphane)-rhodium(I)

- Substance type: yellow powder

- Physical state: solid

- Analytical purity: >99%

- Impurities (identity and concentrations): not stated

- Composition of test material, percentage of components: not stated

- Isomers composition: not stated

- Purity test date: not stated

- Lot/batch No.: FM 36/4/90

- Expiration date of the lot/batch: not stated

- Stability under test conditions: stable

- Storage condition of test material: closed container room temperature

- Other:
- Purity test method: Gravimetric Rh - analysis
- Solubility: insoluble in water and n-hexane; soluble in chloroform at 1 g/60 ml, soluble in acetone at 1 g/100 ml
- pH: ~7

Test animals

Species:

rabbit

Strain:

other: White Russian (Albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ASTA Pharma AG

- Age at study initiation: 7-12 months

- Weight at study initiation: 2.59-2.77 kg

- Housing: Stainless steel cages with grating floor, size 48.5 cm(l) x 40 cm (b) x 36.5 cm (h); 1/cage

- Diet (e.g. ad libitum): Standard diet, Ssniff K, special diet for rabbits; ~120 g/day per animal

- Water (e.g. ad libitum): municipal drinking water, automatic drinking water system with drinking nipples; ad libitum

- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22.5

- Humidity (%): 30-70

- Air changes (per hr): not stated

- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: not stated

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: control area on opposite flank of each treated animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

- Concentration (if solution): not applicable, moistened

VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable, enough to moisten test material

- Concentration (if solution): not applicable, moistened

- Lot/batch no. (if required): not applicable

- Purity: demineralised water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after patch removal (all 3 animals), then daily to day 6 (1 animal)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ~6.25 cm2

- % coverage: not stated

- Type of wrap if used: site of application covered with linen cloth which adhered to a synthetic film glue; bandage wrapped several times around the trunk providing complete occlusion

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at end of exposure period

- Time after start of exposure: 4 hours

SCORING SYSTEM: Qualitative and quantitative assessment using Draize method - erythema/eschar and oedema, both scored on a scale of 0-4; also occurrence of further reactions of the skin (e.g. corrosive effects) and clinical signs (indicating systemic toxicity)

Irritation index calculated from sum of mean values of individual scores at the 4 observation times for erythema/eschar and for oedema; graded using modification of the method of Gilman et al., 1983

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: All time points: 1, 24, 48 and 72 hours, 4 and 6 days

Score:

ca. 0

Max. score:

8

Irritant / corrosive response data:

Erythema/eschar: 0 at all time points in all animals
Oedema: 0 at all time points in all animals.
Corrosion: no effects noted
Corresponding control patch on opposite flank of each animal: no reactions

Other effects:

No systemic effects observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a guideline study, to GLP, carbonylhydridotris(triphenylphosphane)-rhodium(I) was not irritating to the skin of rabbits following a 4-hr occlusive application.

Executive summary:

The skin irritation potential of carbonylhydridotris(triphenylphosphane)-rhodium(I) was evaluated in White Russian rabbits in a study conducted according to OECD Test Guideline 404 and to GLP.

 

The test material (0.5 g, moistened with water) was applied to the shaved dorsal skin of 3 animals, covered for 4 hours (occluded) and washed off. Skin reactions were evaluated 1, 24, 48 and 72 hours after patch removal and, in 1 animal, at 4 and 6 days. No erythema/eschar or oedema was observed at any time point in any animal. No corrosive effects or systemic toxicity was noted. Carbonylhydridotris(triphenylphosphane)-rhodium(I) produced a primary dermal irritation index of 0 and was not irritating to the skin of rabbits under the conditions of the test.

 

Based on the results of this study, no classification for skin irritation is required according to EU CLP criteria (EC 1272/2008).