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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 September 1989 to 06 September 1989
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:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(minor (1 deg C) deviation from recommended guideline temperature of animal cage; unlikely to be of significant magnitude to affect test)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
15336-18-2
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Ammonium hexachlororhodate III
- Substance type: red-coloured powder
- Physical state: solid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: “Assay: 29.39%” [presumably percentage of rhodium].
- Lot/batch No.: S0711559
- Expiration date of the lot/batch: No data
- Stability under test conditions: Not determined
- Storage condition of test material: At room temperature in a plastic flip-top jar

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: “approximately” between 12 and 16 weeks
- Weight at study initiation: 3.06 kg
- Housing: solitary, in a suspended metal cage
- Diet (e.g. ad libitum): ad libitum “Rabbit Diet” from Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK
- Water (e.g. ad libitum): ad libitum mains drinking water
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 60-68 [relative]
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye of treated animal served as concurrent control
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (approximately 92 mg)

Duration of treatment / exposure:
Eyelids were briefly closed for about one second immediately after application and there was no subsequent washing to remove the test material.
Observation period (in vivo):
Severe ocular reaction resulted in humane sacrifice of the animal 48 hours after application of the test material.
Number of animals or in vitro replicates:
One male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed.

SCORING SYSTEM: Assessment of damage/irritation was made quantitatively and qualitatively using the Draize scale (see Attachment) at 1, 24 and 48 hours after application of the test substance into the eye. The ocular irritation potential was calculated from this assessment using a modified version of the Kay & Calandra system (see Attachment).

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: single (only) animal
Time point:
other: 1 hr
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: single (only) animal
Time point:
other: 24 hr
Score:
20
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
other: single (only) animal
Time point:
other: 48 hr
Score:
40
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
other: single (only) animal
Time point:
other: 1 hr, 24 hr and 48 hr
Score:
5
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
other: single (only) animal
Time point:
other: 1 hr
Score:
12
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
other: single (only) animal
Time point:
other: 24 hr
Score:
18
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
other: single (only) animal
Time point:
other: 48 hr
Score:
20
Reversibility:
not reversible
Remarks on result:
other: Sloughing of the conjunctival membrane was recorded.
Irritation parameter:
overall irritation score
Basis:
other: single (only) animal
Time point:
other: 1 hr
Score:
17
Reversibility:
not reversible
Irritation parameter:
overall irritation score
Basis:
other: single (only) animal
Time point:
other: 24 hr
Score:
43
Reversibility:
not reversible
Irritation parameter:
overall irritation score
Basis:
other: single (only) animal
Time point:
other: 48 hr
Score:
65
Reversibility:
not reversible
Remarks on result:
other: This was the maximum total score reached before the animal was humanely sacrificed.
Irritant / corrosive response data:
Iridial inflammation and moderate conjunctival irritation were seen one hour after application of the test material. Within 48 hours there was persistent iridial inflammation, moderate corneal opacity over most of the cornea, and severe conjunctival irritation (redness, swelling and discharge of the conjunctivae reached a maximum score on the Draize scale and sloughing of the conjunctival membrane was reported at 48 hours; see Table 1 for details.) Thereafter the rabbit was humanely sacrificed.

See attchment
Other effects:
No systemic effects were reported.

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, instillation of ammonium hexachlororhodate (III) (0.1 mL; 92 mg) to the eye of a single male rabbit caused severe irritation that required sacrifice after 48 hr. No further animals were tested.
Executive summary:

In an OECD Test Guideline 405 study, conducted according to GLP, ammonium hexachlororhodate (III) (0.1 mL; 92 mg) was instilled into the conjunctival sac of a single male New Zealand White rabbit and both lids were briefly closed. 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 and 48 hr post-application.

Severe irritation was observed, with symptoms including iridial inflammation, moderate corneal opacity and severe conjunctival redness, swelling and discharge. After 48 hr, the total irritation score was 65 (out of a maximum possible score of 110, based on the Draize scale) and sloughing of the conjunctival membrane was reported. The animal was humanely sacrificed and no further animals were tested. No systemic toxicity was observed.

As the results were based on only one rabbit, it is not possible to give a definitive interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered prudent to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.