Di-mu-chloro-bis(hapto-1,5-cyclooctadiene)dirhodium(I)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 June 1984 – 16 June 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to a protocol based on OECD guideline No. 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

The study was performed according to Safepharm Standard Protocol Number GM 04/82/40B which is based on OECD Guideline 404.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Di-mu-chloro-bis(hapto-1,5-cyclooctadiene)dirhodium(I)

EC Number:

235-157-6

EC Name:

Di-mu-chloro-bis(hapto-1,5-cyclooctadiene)dirhodium(I)

Cas Number:

12092-47-6

Molecular formula:

C16H24Cl2Rh2

IUPAC Name:

di-mu-chloro-bis(hapto-1,5-cyclooctadiene)dirhodium(I)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Rh-93 chloro (cycloocta-1, 5-diene) rhodium (I) dimer (reference MS 400)
- Substance type: orange powder
- Physical state: solid
- Lot/batch No.: CC 261
- Stability under test conditions: not determined
- Storage condition of test material: ambient temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leics
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.75-3.01 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum standard laboratory diet (Rabbit Diet, AW Tindall Ltd, Holbeach, Lincolnshire)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 4
- Humidity (%): 70-75
- Air changes (per hr): 10 changes / hr
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit): enough to moisten the test material
- Purity: sterile distilled water

Duration of treatment / exposure:

4 hrs

Observation period:

Approx. 1hr following removal of the patches, and 24, 48 and 72 hrs later. If irritation persisted at the 72 hr-reading, a further observation was made 7 days following removal of the patches.

Number of animals:

3 (sex unspecified)

Details on study design:

TEST SITE
- Area of exposure: not specified
- Type of wrap if used: The site of application was covered with 6.25 cm2 of surgical gauze two layers thick. This was secured in position with two lengths of Sleek adhesive strapping in the form of a cross and the trunk of the animal was wrapped in an elasticated corset to prevent access to the patch.

REMOVAL OF TEST SUBSTANCE
- Washing: yes – gentle swabbing with cotton wool soaked in lukewarm water.
- Time after start of exposure: 4 hrs

SCORING SYSTEM: The sites were scored according to Draize, 1959 – see below. A full description of any serious lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects were made. The scores for erythema and oedema at the 24 and 72 hr readings were totalled for the three test animals and divided by 6 to give the Primary Cutaneous Irritation Index, which was used to classify the skin irritation properties according to:

Primary Irritation Index Classification
0 non-irritant
>0 - 2 mild irritant
>2 - 5 moderate irritant
>5 - 8 severe irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hrs after removal of the patches

Score:

ca. 0

Max. score:

8

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hrs after removal of the patches

Score:

ca. 0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hrs after removal of the patches

Score:

ca. 0

Max. score:

4

Irritant / corrosive response data:

None of the rabbits showed any observable response to treatment throughout the 72-hr observation period.

Other effects:

None reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a guideline skin irritation study, RH-93 chloro (cycloocta-1, 5-diene) rhodium (I) dimer (0.5 g) produced a primary irritation index of 0 following 4-hr semi-occlusive application to the clipped, intact skin of three rabbits.

Executive summary:

RH-93 chloro (cycloocta-1, 5-diene) rhodium (I) dimer (MS 400) (0.5 g) was applied (semi-occluded) to the clipped, intact skin of three New Zealand white rabbits (sex unspecified). After 4 hrs, the dressings were removed and the skin sites gently washed and assessed for erythema (and eschar) and oedema formation 1, 24, 48 and 72 hrs after removal of the patches. The values of the individual grades obtained from the skin areas at observation times 24 and 72 hrs were totalled and divided by 6 to give a primary irritation index of 0.0. No overt sings of toxicity were reported. RH-93 chloro (cycloocta-1, 5-diene) rhodium (I) dimer was considered as non-irritant in this test.

 

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