Carbonylhydrotris(triphenylphosphine)rhodium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not stated but QA inspections on 07-Jan-1991 and 15-Jan-1991 during the experimental phase

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:

1991

Report date:

1991

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:

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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

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: in a closed container at room temperature

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

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian (Albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ASTA Pharma AG

- Age at study initiation: male 8 months, females 8 and 10 months

- Weight at study initiation: male 2.74 kg, females 2.90 and 3.17 kg

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

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

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

- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23

- Humidity (%): 40-55

- Air changes (per hr): not stated

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

IN-LIFE DATES: Not stated but QA inspections on 07-Jan-1991 and 15-Jan-1991 during the experimental phase

Test system

Vehicle:

unchanged (no vehicle)

Controls:

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

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.038 or 0.032 g (approximate volume 0.1 ml)
- Concentration (if solution): not applicable

VEHICLE: none

Duration of treatment / exposure:

Treated eyes not rinsed but physiological processes would be expected to result in the removal of the test substance

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable

SCORING SYSTEM: Observations made at 1, 24, 48 and 72 after application of test material; signs of irritation assessed qualitatively and quantitatively using Draize scale - cornea (opacity 0-4, area involved 1-4), iris (0-2) and conjunctiva (redness 0-3, chemosis 0-4, discharge 0-3); irritation index calculated as the sum of these scores (0-110); graded according to Gilman et al., 1983

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

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:

2

Max. score:

110

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

80

Reversibility:

other: not applicable

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

10

Reversibility:

other: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

2.3

Max. score:

20

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Overall irritation index: 2;
Cornea - opacity and area involved: 0 for all 3 animals at all 4 time points;
Iris: 0 for all 3 animals at all 4 time points;
Conjunctiva - redness - 1, 24, 48 and 72 hours: 1, 2, 1 and 0 (#1), 1, 1, 0, 0 (#2), 0, 1, 1 0 (#3);
Conjunctiva - chemosis: 0 for all 3 animals at all 4 time points;
Conjunctiva - discharge: 2 for all 3 animals at 1 hour, 0 for all 3 animals at all other time points;
No effects in untreated eye of each animal

Other effects:

No systemic toxicity; no effect on general condition of animals

Any other information on results incl. tables

Table 1: Individual irritation scores

Ocular lesions	Time after exposure/hr	Draize grade
		Animal 1	Animal 2	Animal 3
Corneal opacity	1	0	0	0
	24	0	0	0
	48	0	0	0
	72	0	0	0
Corneal area	1	0	0	0
	24	0	0	0
	48	0	0	0
	72	0	0	0
Iris	1	0	0	0
	24	0	0	0
	48	0	0	0
	72	0	0	0
Conjunctival redness	1	1	1	0
	24	2	1	1
	48	1	0	1
	72	0	0	0
Conjunctival chemosis	1	0	0	0
	24	0	0	0
	48	0	0	0
	72	0	0	0
Conjunctival discharge	1	2	2	2
	24	0	0	0
	48	0	0	0
	72	0	0	0

EU criteria: classification in category 2 applies when a positive response is seen in >=2/3 treated animals at >=1 for cornea and/or >=1 for iris and/or >=2 conjunctival redness and/or >=1 for conjunctival oedema, calculated as a mean score at 24, 48 and 72 hours

 

This calculation produces mean values of 0 for cornea for all 3 animals, 0 for iris for all 3 animals, 1, 0.3 and 0.7 for conjunctival redness for the 3 animals respectively, 0 for conjunctival discharge; therefore category 2 does not apply and the test material is classified as non-irritant by EU criteria

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 rabbit eyes following instillation of 0.038 or 0.032 g (volume 0.1 mL) of the test material to the conjunctival sac of 3 animals.

Executive summary:

The eye irritation potential ofcarbonylhydridotris(triphenylphosphane)-rhodium(I) was evaluated in White Russian rabbits in a study conducted in accordance with OECD Test Guideline 405 and to GLP. A quantity of 0.038 or 0.032 g (volume 0.1 mL) of the test material was placed in the conjunctival sac of 3 animals. The other eye of each animal was not treated and acted as a control. The treated eyes were evaluated at 1, 24, 48 and 72 hr after application and scored for irritation of the cornea, iris and conjunctiva according to the Draize system.

 

No effects were seen on the cornea or iris of any animal at any time point. Slight or moderate redness was seen in the conjunctivae of all animals, but this had reversed after 72 hr. Moderate conjunctival discharge was seen in all animals at 1 hr, but this had reversed after 24 hr. No corrosive or systemic effects were noted.

 

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