Diammonium sodium hexakis(nitrito-N)rhodate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 March - 2 April 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Conducted according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Remarks:

Minor humidity deviations were expected to have no impact on the study outcome

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

Minor humidity deviations were expected to have no impact on the study outcom

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Remarks:

Minor humidity deviations were expected to have no impact on the study outcom

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Diammonium sodium hexakis(nitrito-N)rhodate

EC Number:

264-713-0

EC Name:

Diammonium sodium hexakis(nitrito-N)rhodate

Cas Number:

64164-17-6

Molecular formula:

H4N.1/2N6O12Rh.1/2Na

IUPAC Name:

Diammonium sodium hexakis(nitro-N)rhodate

Details on test material:

- Name of test material (as cited in study report): Diammonium sodium hexakis(nitrito-N)rhodate
- Substance type: Technical product
- Physical state: Solid (yellow/green powder)
- Analytical purity: 100% (rhodium content 15.302%)
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: An analysis report constitutes Appendix 4 of full study report and documents trace amounts of some elements
- Purity test date: 07 October 2011
- Lot/batch No.:RHL 586
- Expiration date of the lot/batch: 01 October 2016
- Stability under test conditions: no data
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%)
- pH of test material: 4.9

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft., 2173 Kartal, Császár road 135, Hungary
- Age at study initiation: ~12 weeks
- Body weight range at the beginning of the in-life phase: 3167 – 3204 g
- Body weight range at the end of the in-life phase: 3402 – 3416 g
- Housing: individually in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet (e.g. ad libitum): Purina and UNI diet (Lot number: 00701211 and 0030 03 12) for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
- Water (e.g. ad libitum): municipal tap water, as for human consumption, ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 24 – 52 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

Following instillation into the conjunctival sac of one eye, the eyelids were held closed for several seconds. No rinsing was performed.

Observation period (in vivo):

1 week (The eyes were examined at 1, 24, 48 and 72 hours, and 1 week after treatment).

Number of animals or in vitro replicates:

3 (males)

Details on study design:

Rinsing of treated eyes was not performed.

The other eye remained untreated and was used for control purposes.

The eyes were examined at 1, 24, 48 and 72 hours, and 1 week after treatment. The nature, severity and duration of all lesions observed were described.

SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002) shown in Appendix 1 of the attached study report.

TOOL USED TO ASSESS SCORE: none reported; presumably subjective observation by an experienced evaluator

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Remarks:

Conjunctival chemosis

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: Mean of 24, 48 and 72-hour timepoints

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

other: Slight chemosis was seen in one animal at one hour; this had resolved by 24 hours

Results 2

Irritation parameter:

other: Conjunctival discharge

Basis:

mean

Time point:

other: Mean of 24, 48 and 72-hour timepoints

Score:

0

Max. score:

3

Reversibility:

other: Not applicable

Remarks on result:

other: Considerable discharge was seen in one animal, and slight discharge in two animals, at 1 hour; this had resolved to normal by 24 hours in all cases

Results 3

Irritation parameter:

other: Conjunctival redness

Basis:

mean

Time point:

other: Mean of 24, 48 and 72-hour timepoints

Score:

0.56

Max. score:

3

Reversibility:

fully reversible

Remarks:

1 week

Remarks on result:

other: One animal was symptom-free by 24 hours, one by 72 hours and one by 1 week

Results 4

Irritation parameter:

cornea opacity score

Remarks:

opacity, degree of density

Basis:

mean

Time point:

other: Mean of 24, 48 and 72-hour timepoints

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

other: No corneal opacity was seen in any animal at any time point

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72-hour timepoints

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Remarks on result:

other: The iris was not affected in any animal at any time point

Irritant / corrosive response data:

Initial Pain Reaction (IPR) (score 2) was observed in all animals.

One hour after the application, conjunctival redness (score 1) and conjunctival discharge (score 1 or score 3) were seen in all animals. Conjunctival chemosis (score 1) was observed in one rabbit.

At 24 and 48 hours after treatment, conjunctival redness (score 1) was observed in two animals.

At 72 hours after treatment, conjunctival redness (score 1) was observed in one animal.

At 1 week after treatment no signs of eye irritation or other clinical signs were observed.

As there were no clinical signs observed, the study was terminated after the 1 week observation.

During the study, the control eye of each animal was symptom-free.

The individual mean scores for each animal (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
chemosis : 0.00, 0.00, 0.00
discharge : 0.00, 0.00, 0.00
redness : 1.00, 0.67, 0.00
cornea opacity : 0.00, 0.00, 0.00
iris : 0.00, 0.00, 0.00

Other effects:

There were no clinical signs observed that could be related to treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an OECD Test Guideline 405 study, to GLP, diammonium sodium hexakis(nitrito-N)rhodate (0.1 g) caused some conjunctival effects in the eyes of three male rabbits within 1 hr of instillation, but these effects were fully reversible within 1 week.

Executive summary:

In an in vivo eye irritation study carried out in accordance with OECD Test Guideline 405, and to GLP, 0.1 g of powdered diammonium sodium hexakis(nitrito-N)rhodate was instilled into the conjunctival sac of one eye of 3 male New Zealand White rabbits. Following instillation the eyelids were held closed for several seconds; no rinsing was performed. The other eye remained untreated and was used for control purposes. The eyes were examined at 1, 24, 48, 72 hours, as well as 1 week after treatment, and scored according to the Draize system.

 

Mild conjunctival effects (including redness, chemosis and discharge) occurred within 1 hour of application. These were either reduced or absent at 24 hours and were fully reversible within 1 week.

 

Based on the results of this study, diammonium sodium hexakis(nitrito-N)rhodate does not require classification for eye irritation, according to EU CLP criteria (EC 1272/2008).