Tetraammonium decachloro-μ-oxodiruthenate(4-)

Endpoint summary

Description of key information

In an in vitro reconstructed human epidermis (EpiSkin) assay, conducted in accordance with OECD Test Guideline 439 and to GLP, tetraammonium decachloro-μ-oxodiruthenate was considered to be non-irritating to skin (Hargitai, 2015).

 

In an OECD Test Guideline 405 study, to GLP, tetraammonium decachloro-μ-oxodiruthenate (0.1 g) caused immediate significant conjunctival and corneal irritant effects in the eye of a single male rabbit, which were not fully reversible within 3 weeks (Zelenák, 2015).

 

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 vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22-24 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

OECD Guidelines for Testing of Chemicals, Section 4, No. 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method” adopted 22 July 2010

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EpiSkin™ SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study: Validation of the EpiSkin™ test method 15 min - 42 hours for the prediction of acute skin irritation of chemicals. Available at: [http://ecvam.jrc.ec.europa.eu]

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: IN VITRO SKIN IRRITATION: RECONSTRUCTED HUMAN EPIDERMIS MODEL TEST in relation to Regulation (EC) No 440/2008 (as amended) and Regulation (EC) No 1907/2006 on REACH (Annex III, B.46).

Deviations:

no

Principles of method if other than guideline:

The test is designed to predict and classify the skin irritant potential of chemicals according to chemical safety regulations, using the reconstructed human epidermis model EPISKIN-SM and parameters related to skin irritation.
EPISKIN-SM is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Its use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability. Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of cell viability in treated tissues is compared to negative controls and expressed as a %. The % reduction in viability is used to predict the irritation potential.

The EPISKIN-SM has been found scientifically valid for reliably predicting no label and R38 (irritant) substances in respect to the previous EU classification scheme and has been confirmed in April 2009 by ESAC for use under the UN GHS system as "applicable to all authorities". It is approved by international regulatory agencies as a replacement for the identification of irritants/corrosives in the in vivo rabbit skin assay(OECD 404).

GLP compliance:

yes (incl. QA statement)

Species:

human

Strain:

other: Reconstructed human epidermis model (see details below)

Details on test animals or test system and environmental conditions:

EPISKIN-SM (Source: SkinEthic, France, Batch No.:12-EKIN-008, Expiry date: 27 February 2012) is a three-dimensional human epidermis model. Adult human-derived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

Type of coverage:

other: Applied evenly to the epidermal surface following the application of 10 ul distilled water to this surface

Preparation of test site:

other: in vitro cell culture

Vehicle:

water

Remarks:

distilled

Controls:

other: negative control skin unit tested in triplicate

Amount / concentration applied:

20 mg to each of three test skin units.
20 µl PBS (phosphate buffered saline) was added to each of the three negative control skin units and 20 µl SDS (sodium dodecyl sulfate, 5% aqueous solution) was added to each of the three positive control skin units.
For additional control for staining effects of the test item, 10 µl distilled water was applied to the epidermal surface of a single skin unit to ensure good contact with the epidermis, then 20 mg of the test item was applied evenly to the epidermal surface.

Duration of treatment / exposure:

Exposure for 15 minutes (± 0.5 min) at room temperature (20-37°C).
Then incubated with fresh “maintenance medium” for 42 hours (± 1h) at 37°C.

Observation period:

Not applicable to this test system

Number of animals:

Not applicable to this test system

Details on study design:

EPISKIN-SM assay plate contained reconstructed epidermis units (area: 0.38 cm2); each was attached to the base of a tissue culture vessel and maintained on nutritive agar.

After test substance exposure and subsequent incubation, preparations for cell viability determination were: incubation with MTT solution (at 37 degrees C for 3 hours) followed by incubation with acidified isopropanol for formazan extraction (around two hours at room temperature with gentle agitation).

For cell viability measurements, the OD (Absorbance / Optical Density) of the samples in a spectrophotometer was read at 540 nm using acidified isopropanol solution blank (6×200 µL). (The validity of the microplate reader was verified with a standard verification plate daily before use. The standard plate was calibrated yearly by the manufacturer.)

For each treated tissue, OD (as adjusted for colouring potential of the test substance) was calculated and the tissue viability was expressed as a % relative to negative control.

Criteria for classification as irritant/non-irritant: If the resulting mean relative viability (as adjusted for intrinsic colour) is less than or equal to 50% of the negative control, the test substance is considered to be irritant to skin.

Irritation / corrosion parameter:

% tissue viability

Remarks:

Time point: 42 hours

Run / experiment:

mean of 3 replicates

Value:

86

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Mean cell viability (as adjusted for intrinsic colour) was 86% of the negative control (range 85%-86%).

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vitro reconstructed human epidermis (EpiSkin) assay, conducted in accordance with OECD Test Guideline 439 and to GLP, tetraammonium decachloro-μ-oxodiruthenate was considered to be non-irritating to skin.

Executive summary:

Tetraammonium decachloro-μ-oxodiruthenate was tested for skin irritation potential in an in vitro reconstructed human epidermis model (EpiSkin assay) conducted in accordance with OECD Test Guideline 439, and to GLP.

 

EpiSkin is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Its use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability. Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of cell viability in treated tissues is compared to negative controls and expressed as a %. If the resulting mean relative viability (as adjusted for intrinsic colour) is less than or equal to 50% of the negative control, the test substance is considered to be irritant to skin.

 

Following a 15-minute exposure to the test substance, the test system skin cell viability was calculated to be greater than 50% (the average was 86% and the range was 85 -86%), and it was therefore considered to be non-irritating to skin.

 

Under the conditions of this assay, tetraammonium decachloro-μ-oxodiruthenate does not require classification for skin irritation according to EU CLP criteria (EC 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

23 March 2012 - 03 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

The relative humidity was occasionally out of the target range during the study and the acclimatisation period, and the draft report was issued later than indicated in the study plan.

GLP compliance:

yes (incl. QA statement)

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: approximately 11 weeks
- Weight at study initiation: 2727 g
- Housing: AAALAC approved metal wire rabbit cages of an open wire structure, placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet (e.g. ad libitum): Purina and UNI diet (Lot number: 0030 03 12 and 0060 04 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: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 24 – 67 % (relative humidity)
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test item. Rinsing with physiological saline was performed at 24 and 48 hours, and after 1 and 2 weeks.

Observation period (in vivo):

The eyes were examined at 1, 24, 48, 72 hours, 1, 2 and 3 weeks after treatment.

Number of animals or in vitro replicates:

1 male

Details on study design:

Rinsing with physiological saline was performed at 24 and 48 hours, and after 1 and 2 weeks.
Individual reactions of the animal were recorded at each observation time. The nature, severity and duration of all lesions observed were described.
Any clinical signs of toxicity or signs of ill- health during the study were recorded.
At the end of the observation period, the animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol® 40% anaesthesia.

SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD guideline no. 405 shown (see below in "Any other information on materials and methods including tables").

TOOL USED TO ASSESS SCORE: apparently visual assessment, presumably by an experienced technician.

Results were presented and interpreted according to Regulation (EC) No 1272/2008, as follows:

Irreversible effects on the eye/serious damage to eyes (Category 1): Substances that have the potential to seriously damage the eyes are classified in Category 1 (irreversible effects on the eye). These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight.

Category for irreversible eye effects: If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days;
and/or
— at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 3 and/or iritis > 1.5 when calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

Reversible effects on the eye/irritating to eyes (Category 2): Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).

Category for reversible eye effects: If, when applied to the eye of an animal, a substance produces (at least in 2 of 3 tested animals) a positive response of:
- corneal opacity ≥ 1 and/or
- iritis ≥ 1, and/or
- conjunctival redness ≥ 2 and/or
- conjunctival oedema (chemosis) ≥ 2

... when calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Irritation parameter:

other: Initial pain reaction

Time point:

other: 0 hr

Score:

2

Remarks on result:

other: Based on this response, 2 additional animals were not treated

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 3 weeks

Irritation parameter:

other: Conjunctival discharge

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: Maximum-scoring discharge continued until the end of the observation period of 3 weeks

Irritation parameter:

other: Conjunctival redness

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 3 weeks

Remarks on result:

other: The conjunctivae were discoloured black by the test item; redness of 3.00 was assumed for the reading 24 hours after exposure

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 3 weeks

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Remarks on result:

other: No effects on the iris were reported

Irritant / corrosive response data:

One hour after the application: Conjunctival discharge (score 3), chemosis (score 2) and corneal opacity (score 2, area 4) were observed. The conjunctivae and the cornea were discoloured black by the test item, therefore observation of the redness of the iris and the conjunctivae was not possible.

At 24 hours after treatment: Conjunctival discharge (score 3), chemosis (score 2) and corneal opacity (score 1, area 4) were observed. The conjunctivae and the cornea remained discoloured black by the test item therefore observation of the redness of the iris and the conjunctivae was not possible.

At 48 and 72 hours after treatment: Conjunctival redness (score 3), discharge
(score 3), chemosis (score 2) and corneal opacity (score 1, area 4) were observed. The conjunctivae and the cornea remained discoloured black by the test item.

At 1 week after treatment: Conjunctival redness (score 2), discharge (score 3), chemosis (score 2) and corneal opacity (score 1, area 4) were observed. Test item residue was observed on the conjunctivae and on the nictitating membrane.

At 2 weeks after treatment: Conjunctival redness (score 2), discharge (score 3) and chemosis (score 2) were observed and corneal opacity (score 1, area 1) was seen in the animal. Test item residue was observed on the conjunctivae and on the nictitating membrane.

At 3 weeks after treatment: Conjunctival redness (score 2), discharge (score 3) and chemosis (score 1) were observed and corneal opacity (score 1, area 1) was seen in the animal. Test item residue was observed on the conjunctivae and on the nictitating membrane.

Other effects:

The conjunctivae and the cornea were discoloured black by the test item; this colouration remained for 72 hours and, at the end of the 3-week observation period, test item residue remained on the conjunctivae and on the nictating membrane.

No mortality was observed during the study.

The body weight and body weight change were considered to be normal with no indication of treatment related effect.

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

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

In a guideline study, to GLP, tetraammonium decachloro-μ-oxodiruthenate caused immediate significant conjunctival and corneal irritant effects when applied to the eye of a single male rabbit, which were not fully reversible within 3 weeks.

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 tetraammonium decachloro-μ-oxodiruthenate was instilled into the conjunctival sac of the left eye of a single male New Zealand White rabbit. Following instillation the eyelids were held closed for several seconds; rinsing with physiological saline was performed at 24 and 48 hours, and after 1 and 2 weeks. 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, 2 and 3 weeks after treatment, and scored according to the Draize system.

Immediate significant conjunctival and corneal irritant effects were observed within one hour that persisted at 72 hours and were not fully reversible within the 3-week observation period.

Based on the results of this study, the substance should be classified for serious eye damage (category 1) according to EU CLP criteria (EC 1272/2008).

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Experimental work took place on 13 March 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Principles of method if other than guideline:

The Enucleated Eye Test with isolated eyes of chickens has been recognized as a valuable alternative to the Draize eye irritation test, because it represents a test system nearest to the in vivo test, without the need to use live animals. In the Isolated Chicken Eye Test (ICET) the test compound is applied in one single dose onto the cornea of isolated eyes, which are obtained from slaughter animals. This method can provide detailed information about the effects of test items on the cornea, and is useful to compare products, to classify test items for regulatory use when they are severe irritants or corrosive to the eye, and thus to avoid the need to test severe eye irritants in vivo. The test is described in OECD 438 and is approved by international regulatory agencies as a replacement for the identification of corrosives and severe irritants in the in vivo Rabbit eye assay (OECD 405).

GLP compliance:

yes (incl. QA statement)

Species:

other: Chicken (isolated eyes only)

Strain:

other: ROSS 308

Details on test animals or tissues and environmental conditions:

- Source of chicken eyes: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út. 129
- Age of chickens when slaughtered: approximately 7 weeks
- Chickens heads were transported to CiToxLAB Hungary Ltd. at ambient temperature at the earliest convenience following slaughter (time lapse not further specified). The heads were received at CiToxLAB Hungary Ltd. and processed within approximately 2 hours of collection.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 +/- 1.5 degrees C during acclimatisation and treatment (acclimatisation time was 45-60 minutes)
- Humidity (%): Ambient humidity not specified but various measures to maintain humidity around the isolated eye during acclimatisation and treatment are described.

Vehicle:

other: None

Controls:

not required

Amount / concentration applied:

Test substance: 30 mg (powdered test item applied uniformly to the entire surface of the cornea).
Positive control: 30 mg imidazole (powdered test item applied uniformly to the entire surface of the cornea).
Negative control: 30 μl sodium chloride (Salsol solution 0.9%).

Duration of treatment / exposure:

10 seconds from the end of application (then rinsed with 20 ml isotonic saline).

Observation period (in vivo):

240 minutes. Rinsing with 20 ml saline was performed at interim time points of 30, 75, 120, 180 and 240 minutes (+/- 5 minutes in each case).

Number of animals or in vitro replicates:

Test substance and positive control: three eyes each.
Negative control: one single eye.

Details on study design:

Eyes served as their own controls - baseline measurements of corneal thickness and corneal opacity were taken before treatment and at each interim time-point of 30, 75, 120, 180 and 240 minutes (+/- 5 minutes in each case). Flourescein retention measurements were taken before treatment and approximately 30 minutes after the post-treatment rinse.

Irritation parameter:

percent corneal swelling

Remarks:

up to 75 min

Run / experiment:

mean of three values

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Qualtitative assessment ICE Class I

Irritation parameter:

percent corneal swelling

Remarks:

up to 240 min

Run / experiment:

mean of three values

Value:

1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Qualitative assessment ICE Class I

Irritation parameter:

cornea opacity score

Run / experiment:

mean of three values

Value:

0.83

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Qualitative assessment ICE Class II

Irritation parameter:

fluorescein retention score

Run / experiment:

mean of three values

Value:

0.83

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Qualitative assessment ICE Class II

Irritant / corrosive response data:

Not severly irritating or corrosive.
Overall results indicate that this substance may be (borderline) slightly irritating.

Other effects:

The test item remained adhered to the cornea at the end of the observation period, even after rinsing. No conclusion of in vivo significance can be made from this observation, since in vivo eyelids will probably clear the surface, but abrasion may occur.

Positive control was valid: Mean maximum corneal swelling at up to 240 minutes was 7%, mean maximum corneal opacity was 3.83 and mean fluorescein retention was 2.67, resulting in ICE Class categorisations of II, IV and IV, respectively, indicating that it was severely irritating. The corresponding GHS Classification would be Category 1.

Negative control valid: Mean maximum corneal swelling at up to 240 minutes was 0%, mean maximum corneal opacity was 0.00 and mean fluorescein retention was 0.00, resulting in ICE Class categorisations of I, I and I, respectively, indicating no significant effects on the chicken eye in this study.

Interpretation of results:

other: Does not require classification as a severe eye irritant

Conclusions:

In an in vitro eye irritation study in isolated chicken eyes, conducted in accordance with OECD Test Guideline 438, tetraammonium decachloro-μ-oxodiruthenate appeared to be not severely irritating or corrosive and not to require classification as a severe eye irritant. However, irritation criteria indicate that it may be (borderline) slightly irritating to the eye, and it remained adhered to the corneal surface after the post-treatment rinse. As such, an in vivo study was conducted to determine classification.

Executive summary:

Tetraammonium decachloro-mu-oxodiruthenate was tested in an in vitro eye irritation study in isolated chicken eyes in accordance with OECD guideline 438 and to GLP.

After reference measurements, 30 mg of test material was applied to cover the entire surface of the cornea. After 10 seconds, the surface was rinsed with saline and observations of corneal thickness and corneal opacity were made over a 240 minute post-exposure period; fluorescein retention was measured at 30 minutes. Positive control eyes were treated in a similar way with 30 mg imidazole and a single negative control eye was treated with 30 µL of isotonic saline.

Overall results suggested that tetraammonium decachloro-mu-oxodiruthenate was not severely irritating or corrosive and not to require classification as a severe eye irritant, although irritation criteria indicate that it may be (borderline) slightly irritating to the eye. It remained adhered to the corneal surface after the post-treatment rinse - no conclusion of the in vivo significance can be made from this observation since in vivo eyelids will probably clear the surface, although abrasion may occur. An in vivo study is required for precise classification.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No relevant human irritation/corrosion data were identified.

 

Tetraammonium decachloro-μ-oxodiruthenate was tested for skin irritation potential in an in vitro reconstructed human epidermis model (EpiSkin assay) conducted in accordance with OECD Test Guideline 439, and to GLP. EpiSkin is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Its use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability. Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of cell viability in treated tissues is compared to negative controls and expressed as a %. If the resulting mean relative viability (as adjusted for intrinsic colour) is less than or equal to 50% of the negative control, the test substance is considered to be irritant to skin. Following a 15-minute exposure to the test substance, the test system skin cell viability was calculated to be greater than 50% (the average was 86% and the range was 85 -86%), and it was therefore considered to be non-irritating to skin (Hargitai, 2015).

 

In an in vitro eye irritation study in isolated chicken eyes, conducted in accordance with OECD Test Guideline 438, tetraammonium decachloro-μ-oxodiruthenate appeared to be not severely irritating or corrosive and not to require a classification as a severe eye irritant. However, irritation criteria indicate that it may be (borderline) slightly irritating to the eye, and it remained adhered to the corneal surface after the post-treatment rinse (Gönczöl, 2015). As such, an in vivo study was conducted to determine classification (see below).

 

In an in vivo eye irritation study carried out in accordance with OECD Test Guideline 405, and to GLP, 0.1 g of tetraammonium decachloro-μ-oxodiruthenate was instilled into the conjunctival sac of the left eye of a single male New Zealand White rabbit. Following instillation the eyelids were held closed for several seconds; rinsing with physiological saline was performed at 24 and 48 hours, and after 1 and 2 weeks. 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, 2 and 3 weeks after treatment, and scored according to the Draize system. Immediate significant conjunctival and corneal irritant effects were observed within one hour that persisted at 72 hours and were not fully reversible within the 3-week observation period (Zelenák, 2015).

 

No respiratory tract irritation data were identified. A new study was not conducted as it is not a REACH Standard Information Requirement.

Justification for classification or non-classification

Based on the results of the available (in vitro) skin irritation study and the (in vivo and in vitro) eye irritation studies, tetraammonium decachloro-μ-oxodiruthenate does not require classification for skin irritation, but should be classified for serious eye damage (category 1), according to EU CLP criteria (EC 1272/2008).