Registration Dossier

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:
2012-10-01 to 2012-10-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study relibale without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
inspection date: 2012-07-10

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): COBALT BORATE NEODECANOATE- Physical state: blue solid- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS - New Zealand White (Hsdlf:NZW) strain rabbits- Source: Harlan Laboratories UK Ltd., Leicestershire, UK- Age at study initiation: twelve to twenty weeks old- Weight at study initiation: 2.69 or 3.10 kg- Housing: the animals were individually housed in suspended cages.- Diet (ad libitum): 2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK- Water (ad libitum): mains drinking water- Acclimation period: at least five daysThe 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.ENVIRONMENTAL CONDITIONS- Temperature: 17 to 23°C- Relative humidity: 30 to 70%- Air exchange: at least fifteen changes per hour- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): a volume of 0.1 ml of the test item, which was found to weigh approximately 96 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
approximately 1 hour and 24, 48 and 72 hours following treatment as well as on days 7 and 14
Number of animals or in vitro replicates:
2 male rabbits
Details on study design:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.INITIAL AND CONFIRMATORY TESTInitially, a single rabbit was treated. Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the six point scale (please refer to table 2 in the field "Any other information on materials and methods incl. tables" below).After consideration of the ocular responses produced in the first treated animal, a second animal was treated.SCORING SYSTEM: according to the Draize scaleAny other ocular effects were also noted.Any clinical signs of toxicity, if present, were also recorded.Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Initial pain reaction: practically no initial pain; Slight to moderate discharge was observed at the 1, 24 and 48 hour observations.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Slight iridial inflammation was observed at the 1 hour observation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Moderate conjunctivae redness was observed at the 1 hour observation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Moderate chemosis was observed at the 1 hour observation.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Initial pain reaction: slight initial pain; Moderate to severe discharge was observed at the 1, 24, 48 and 72 hour observations.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Slight iridial inflammation was observed at the 1 hour observation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Moderate conjunctivae redness was observed at the 1 hour observation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Moderate chemosis was observed at the 1 hour observation.
Irritant / corrosive response data:
Scattered or diffuse corneal opacity was noted in one treated eye at the 24, 48 and 72-hour observations.Iridial inflammation was noted in both treated eyes one hour after treatment and at the 24 and 48-hour observations and persisted in one treated eye at the 72-hour observation.Moderate conjunctival irritation was noted in both treated eyes one hour after treatment and at the 24 and 48-hour observations. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation noted in the other treated eye at the 72-hour observation. Minimal conjunctival irritation was noted in one treated eye at the 7-day observation.One treated eye appeared normal at the 7-day observation and the other treated eye appeared normal at the 14-day observation.
Other effects:
- Bodyweight: both animals showed expected gain in bodyweight during the study.

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The test material is irritating to the eyes.According to 67/548/EC and subsequent regulations, the substance is not classified as an eye irritant.According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is classified as Category 2.