Rhodium chloride (RhCl3), hydrate

Endpoint summary

Description of key information

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 (Mayr, 1986c).
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 (Mayr, 1986d).
No relevant respiratory tract irritation data were identified.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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

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.

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

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]

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]

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No relevant irritation/corrosion human data were identified.

 

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, and rhodium (III) chloride hydrate was 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 (Mayr, 1986c).

 

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, for signs of irritation on the cornea, iris and conjunctiva, using the Draize scale after 1, 24, 48 and 72 hr and once daily, thereafter, for up to 21 days post application. 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 unaffected (Mayr, 1986d).

 

No relevant respiratory tract irritation data were identified.

Justification for selection of skin irritation / corrosion endpoint:
OECD guideline study, and the only skin irritation study available.

Justification for selection of eye irritation endpoint:
OECD guideline study, and the only eye irritation study available.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the results of the available reliable skin and eye irritation studies (in rabbits), rhodium trichloride (hydrate) need not be classified for skin irritation, but 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.