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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:
key study
Study period:
2010-10-28 to 2010-11-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted April 24, 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
May 20, 2008
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tricobalt tetraoxide
- Physical state: Grey-black powder
- Storage condition of test material: Keep containers tightly closed in a dry, cool and well-ventilated place. At room temperature (20 ± 5 °C, provided by Harlan Laboratories Ltd.).

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Hillcrest, Dodgeford Lane, Belton, Loughborough, Leics, LE12 9TE, UK
- Age at study initiation: 12 weeks
- Weight at study initiation: 2301 - 2710 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (ad libitum): Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C (batch no. 25/10, Provimi Kliba AG, 4303 Kaiseraugst, Switzerland)
- Water (ad libitum): Community tap water from Füllinsdorf
- Acclimation period: 5 - 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): Air-conditioned with 10-15 air changes
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- The test item was applied as a weight of 0.1 g/animal, the dose specified in the test guidelines for solid test items.
- On the day of treatment, the test item was applied with an eye glass to the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye
remained untreated and served as the reference control.
- A single animal was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1- and 24-hour examinations, the test was completed using the two remaining animals.
Duration of treatment / exposure:
no applicable
Observation period (in vivo):
approximately 1, 24, 48 and 72 hours after test item instillation
Number of animals or in vitro replicates:
3 (male rabbits)
Details on study design:
The eyes of the animals were examined one day prior to test item administration.

Observation and Scoring:
- The eye reactions were assessed according to Draize scale. Scleral reddening and ocular discharge were also assessed according to following scale (See "Any other information on materials and methods incl. tables"). Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland).
- Viability / Mortality: Daily from acclimatization of the animals to termination of the test.
- Clinical signs (systemic): Daily from acclimatization of the animals to termination of the test.
- Body weights: At start of acclimatization, on the day of application and at termination of observation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #1)
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #2)
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #2)
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #3)
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #3)
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
- The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33 for all animals for reddening and 0.00, 0.33 and 0.00 for chemosis, respectively.
- Slight reddening of the conjunctivae was noted in all animals 1 hour and 24 hours after instillation of the test item. At the same time, slight swelling (chemosis) of the conjunctivae was observed in one animal (#2). Slight reddening of the sclerae was recorded in two animals (#2 and #3) at the 1-hour reading and persisted in one animal (#2) up to the 24-hour reading. Slight ocular discharge was present in all animals at the 1-hour reading and persisted in one animal (#2) up to the 24-hour reading.
- No abnormal findings were observed in the treated eyes of any animals 48 hours after treatment.
- No staining produced by the test item was observed in the treated eyes.
- Black test item remnants were observed in the treated eyes of all animals at the 1-hour reading and persisted in one animal (#2) up to the 24-hour reading.
- No corrosion of the cornea was observed at any of the reading times.
Other effects:
- Viability / Mortality: No intercurrent deaths occurred during the course of the study.
- Clinical signs: No clinical signs were recorded throughout the entire observation period.
- Body weights: The body weight of the animals was within the range commonly recorded for this strain and age.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to 67/548/EEC and subsequent regulations, tricobalt tetraoxide is not classified as an eye irritant.
According to Regulation (EC) No. 1272/2008 and subsequent regulations, tricobalt tetraoxide is not classified as an eye irritant.