Rhodium chloride (RhCl3), hydrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7-28 April 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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, 13569-65-8

IUPAC Name:

20765-98-4, 13569-65-8

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

Test animals / tissue source

Species:

rabbit

Strain:

other: White russian (albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 4 months
- Weight at study initiation: 2.00-2.45 kg
- Fasting period before study: No data
- Housing: Individually housed in ASTA Model stainless steel cages
- Diet (e.g. ad libitum): Standard diet ad libitum (ssniff (K), "Special diet for rabbits"; Fa. Ssniff Spezialfutter GmbH, D-4770 Soest)
- Water (e.g. ad libitum): Water was provided ad libitum in drinking water quality of the Stadtwerke Bielefeld (Municipal Works)
- Acclimation period: Animals were kept for 1 day under test conditions before application of the test material

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye of each animal was not treated and acted as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

Single instillation into the conjunctival sac of the right eye. Eye not rinsed, therefore possibly for 21 days

Observation period (in vivo):

1, 24, 48 and 72 hrs post application and thereafter once daily for 21 days

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: Signs of irritation on the cornea, iris and conjunctiva were assessed quantitatively and qualitatively using the Draize scale and the mean values of the individual grades at examination times 1, 24, 48 and 72 hr expressed by an irritation index. A corresponding graduation was allocated to this index by the following score:

Index Ranges Gradation
0 – 10 non-irritant
11 – 25 slightly irritant
26 – 56 moderately irritant
57-110 severely irritant

TOOL USED TO ASSESS SCORE: Cliptrix pencil light (No. 645) supplied by Varta, Hanover.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

> 62

Max. score:

110

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

47.1

Max. score:

80

Reversibility:

not reversible

Remarks on result:

other: [See irritant/corrosive response section]

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

> 2.8

Max. score:

10

Reversibility:

not specified

Remarks on result:

other: [See irritant/corrosive response section]

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

12.3

Max. score:

20

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: [See irritant/corrosive response section]

Irritant / corrosive response data:

Cornea score
Examination of the cornea revealed opacity of more than half of the cornea area. Details of the iris were discernible in only one of the animals (score 2) whilst the other two showed partial or complete opacity of the corneas (score 4). Vascular infiltration was also noted in all of the animals at the start of the second observation week.

Iris score
The iris of two animals showed moderate circumcorneal hyperemia (score 1) up to the third and 15th day of observation. However, the iris could not be assessed in the third animal at any time points due to the opacity of the whole cornea area.

Conjunctivae score
In the conjunctiva, diffuse beefy redness of all sections (score 3) and swelling with partial eversion of the lids or with the lids about half closed (scores 2 and 3 respectively) were found. The findings had not completely disappeared by the end of the 21-day observation period.

Other effects:

During the whole observation period, discharge with moistening of the lids and hairs just adjacent to the lids and considerable areas around the eyes was detected. Also loss of hair around the eyes occurred. There were no systemic toxic effects and the general condition of the animals was unaffected after conjunctival instillation of the test material.

Any other information on results incl. tables

Table 1: Individual irritation scores for each time point

Eye reaction	Time after the end of the exposure/hr	Draize score
		Animal 1	Animal 2	Animal 3
Corneal opacity	1	1	3	1
	24	1	4	4
	48	2	4	4
	72	1	4	4
Corneal area	1	4	3	4
	24	4	4	3
	48	3	4	3
	72	2	4	3
Iris	1	0	0	0
	24	1	*	1
	48	1	*	1
	72	0	*	1
Redness	1	2	1	1
	24	3	3	3
	48	3	3	3
	72	3	3	3
Chemosis	1	0	2	1
	24	2	3	2
	48	2	3	2
	72	2	2	2
Discharge	1	0	1	0
	24	3	1	2
	48	3	2	2
	72	2	2	2

*: Owing to opacity of the whole corneal area, the iris was non-assessable.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a guideline study, to GLP, undiluted rhodium (III) chloride hydrate (0.1 g) produced a primary irritation index of greater than 62 (out of 110) following instillation into the eye of three rabbits and, therefore, was classified as severely irritant in this test system.

Executive summary:

In an OECD Test Guideline 405 study, conducted according to GLP, undiluted rhodium (III) chloride hydrate (0.1 g) was instilled into the conjunctival sac of the right eye of one male and 2 female White Russian rabbits and both lids were briefly closed by gentle finger pressure. The other eye remained untreated and acted as the control. The treated eye was assessed, without rinsing, both quantitatively and qualitatively, using the Draize scale after 1, 24, 48 and 72 hr and once daily, thereafter, for up to 21 days post application for signs of irritation on the cornea, iris and conjunctiva.

 

The irritation index, calculated as the sum of the scores at observation times 1, 24, 48 and 72 hrs, was determined to be greater than 62 (out of 110) and rhodium (III) chloride hydrate was, therefore, classified as severely irritant in this test system. For one animal, the iris could not be assessed at any time points due to the opacity of the whole cornea area. As well as the irritant effects, a discharge with moistening of the lids and hairs adjacent to the lids or considerable areas around the eye, and loss of hair around the eye could be seen throughout the entire observation period. The effects were found to be partially, but not fully reversible after the 21-day observation period. No indications of systemic toxicity were apparent and the general condition of the animals was undixturbed.

 

Based on the results of this study, rhodium trichloride (hydrate) should be classified for serious eye damage (Category 1), according to EU CLP criteria (EC 1272/2008) as the severe irritant effects observed were irreversible.