Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 April 1986 – 22 April 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline No. 405 and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
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 (incl. QA statement)

Test material

1
Reference substance name:
Rhodium(3+) acetate
EC Number:
247-460-0
EC Name:
Rhodium(3+) acetate
Cas Number:
42204-14-8
Molecular formula:
C6H9O6Rh
IUPAC Name:
Rhodium(3+);triacetate
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): rhodium (III) acetat “braun”
- Substance type: brown crystal
- Physical state: solid
- Composition of test material, percentage of components: 39.54% Rh
- Lot/batch No.: 6091
- Stability under test conditions: stable throughout the test period
- Storage condition of test material: at room temperature
- Other: soluble in water

Test animals / tissue source

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: 4-8 months
- Weight at study initiation: 2.0-2.3 kg
- Housing: individually
- Diet: ad libitum standard diet, ssniff K “special diet for rabbits” supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water: ad libitum
- Acclimation period: 1 day before application of test material

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 6 am-6 pm fluorescent tube lighting, 6 pm-6 am “natural light-dark-rhythm”

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Eye not rinsed, therefore 15 days
Observation period (in vivo):
1, 24, 48 and 72 hrs post application and thereafter once daily to day 15 post-application
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 hrs expressed by an irritation index (see below):

Irritation index Evaluation
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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs
Score:
ca. 42
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Hair loss around the eyes was still evident at 15 days post-application.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs
Score:
ca. 27.5
Max. score:
80
Reversibility:
fully reversible within: 9 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs
Score:
ca. 3.8
Max. score:
10
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs
Score:
ca. 10.5
Max. score:
20
Reversibility:
fully reversible within: 14 days
Other effects:
During the first week of observation there was discharge which moistened the lids and hairs just adjacent to the lids and considerable areas around the eyes. 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.

Any other information on results incl. tables

Table 1: Individual irritation scores for each timepoint.

 Eye reaction  Time after exposure/hr  Draize score      
     Animal 1  Animal 2  Animal 3
 Corneal opacity  1  0  2  1
   24  1  2  1
   48  1  2  2
   72  1  2  2
 Corneal area  1  0  3  4
   24  4  4  4
   48  4  4  4
   72  4  4  4
 Iris  1  0  1  0
   24  1  1  1
   48  1  1  1
   72  0  1  1
 Conjunctival redness  1  1  0  1
   24  2  2  3
   48  3  3  3
   72  3  3  3
 Chemosis  1  0  2  1
   24  1  2  1
   48  1  2  2
   72  1  2  2
 Discharge  1  0  1  1
   24  2  3  2
   48  1  2  2
   72  1  2  2

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline study, to GLP, rhodium (III) acetate “brown” (0.1 g) produced a primary irritation index of 42 (out of 110) following instillation into the conjunctival sac of three rabbits and, therefore, was considered as moderately irritant in this test system.
Executive summary:

In an OECD Test Guideline 405 study, conducted according to GLP, rhodium (III) acetate “brown” (0.1 g) was instilled into the conjunctival sac of one 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 15 days post-application.

 

The sum of the scores at observation times 1, 24, 48 and 72 hrs was combined to give an irritation index of 42 (out of 110) and the test material was, therefore, considered as moderately irritant in this test system. All three animals displayed conjunctival redness scores (averaged over 24, 48 and 72-hr time points) of at least 2, while in two animals corneal opacity scores were above 1 and chemosis scores were at least 2. The observed irritation was fully reversible within the 15-day observation period. 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 arose during the first week of observation, while beyond this time there was loss of hair around the eye. No corrosive effects or systemic toxicity were observed, and the general condition of the animals was unaffected by treatment.

 

Based on the results of this study, the test material would be classified as irritating to the eyes (Category 2) according to EU CLP criteria (EC 1272/2008).