Cobalt, borate propionate complexes

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2011-08-31

Test material

Test material information

Constituent 1

Reference substance name:

Cobalt, borate propionate complexes

EC Number:

295-033-2

EC Name:

Cobalt, borate propionate complexes

Cas Number:

91782-61-5

Molecular formula:

(C3H5O2)3BO3Co3

IUPAC Name:

{[1,5-bis(propanoyloxy)-2,4-dioxa-3-bora-1,5-dicobaltapentan-3-yl]oxy}cobaltio propanoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: solid powder, blue/purple
- 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: 2.72 kg
- Housing: the animals were individually housed in suspended cages.
- Diet (ad libitum): 2930 Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

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.

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 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

Number of animals or in vitro replicates:

1 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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 8 days

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 8 days

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Diffuse corneal opacity was noted in the treated eye one hour after treatment, at the 24, 48 and 72-Hour observations with translucent corneal opacity at the 7-Day observation and opalescent corneal opacity at the additional 8-Day observation.

Iridial inflammation was noted in the treated eye one hour after treatment, at the 24, 48 and 72-Hour, 7 and 8-Day observations Moderate conjunctival irritation was noted in the treated eye one hour after treatment with severe conjunctival irritation noted at the 24, 48 and 72-Hour observations and moderate conjunctival irritation noted at the 7-Day observation. Severe conjunctival irritation was noted at the 8-Day observation.

A conjunctival bulla was noted inside the lower eyelid, approximately 3 mm x 3 mm in size, at the 7 and 8-Day observations. Sloughing of the nictitating membrane and white appearance of the majority of the nictitating membrane were noted in the treated eye at the 8-Day observation.

Due to worsening reactions and signs of pain and discomfort the animal was killed for humane reasons immediately after the 8-Day observation, in accordance with Company policy and current UK Home Office guidelines.

Other effects:

- Bodyweight: both animals showed expected gain in bodyweight during the study.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Conclusions:

The test item is classified as Irreversible effects on the eye (Category 1) according to regulation (EC) No. 1272/2008.