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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2017-01-17 to 2017-04-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 02 October 2012
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Batch No.: 86888
- Colour: grey
- Density: 1300-1900 kg/m³
- Purity: > 99.4 %
- Expiry Date: 1 year after the date of delivery
- Storage Conditions: room temperature, dry conditions, container closed tightly

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: animal 1: approx. 44 weeks old; animal 2: approx. 41 weeks old
- Weight at study initiation: > 2 kg
- Housing: ABS-plastic or Noryl rabbit cages, floor 4200 cm², in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum - Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Water (e.g. ad libitum): ad libitum - Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test item was applied to the test site.
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
The animals were observed for 72 hours after dosing.
Number of animals or in vitro replicates:
2 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with physiological saline (0.9% NaCl) 1 hour after application.

SCORING SYSTEM: Grading system for ocular lesions according to OECD 405

TOOL USED TO ASSESS SCORE: To detect cornea lesions during the observation period, the treated eyes were examined with the aid of a fluorescein solution. The eyes were rinsed with physiological saline 0.9% NaCl after the examination.

TEST PROCEDURE:
Initial test: The in vivo test was performed initially using one animal.
Confirmatory test: The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye using the procedure described. In order to confirm the response, one additional animal was treated in the same manner. According to OECD 405, section 23, treatment of a third animal was omitted as results from the second animal were sufficient to allow for hazard classification determination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
A single ocular application of the test item chromium diboride to rabbits at a dose of 0.1 g produced slight irritant effects, which were fully reversible within 48 hours. Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Other effects:
Neither mortalities nor significant clinical signs of toxicity but local effects were observed. Moreover, the body weight development of all animals was within the expected range

Any other information on results incl. tables

Table 1: Eye Irritation Scores - Animal No. 1
Observation Animal No. 1, Eye Irritation Scores Post-Application After Average Score (24, 48 and 72 hours)
1 hour 24 hours 48 hours 72 hours
Test item Control Test item Control Test item Control Test item Control
Redness 1 0 1 0 0 0 0 0 0.33
Chemosis 0 0 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0 0 0
Cornea 0 0 0 0 0 0 0 0 0

Table 2: Eye Irritation Scores - Animal No. 2
Observation Animal No. 2, Eye Irritation Scores Post-Application After Average Score (24, 48 and 72 hours)
1 hour 24 hours 48 hours 72 hours
Test item Control Test item Control Test item Control Test item Control
Redness 1 0 1 0 0 0 0 0 0.33
Chemosis 0 0 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0 0 0
Cornea 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo acute eye irritation/corrosion study in rabbits, chromium diboride was tested negative regarding irritation to the eye.
Executive summary:

In a primary eye irritation study according to OECD 405, 0.1 g of chromium diboride (>99.4 % purity) was applied into the conjunctival sac of one eye of two male New Zealand White Rabbits, Crl: KBL (NZW). The treated eye was rinsed with physiological saline 1 hour after the application. The untreated eye served as control. Control and treated animals were observed for a period of 72 hours.

Under the conditions of the present study, a single ocular application of the test item to rabbits at a dose of 0.1 g produced slight irritant but not corrosive effects in both animals, which were fully reversible within 48 hours in both animals. Neither mortalities nor significant clinical signs of toxicity were observed. Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.

On the basis of the test results and in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008, the substance should be not classified.