Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cobaltate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 17 to 20, 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The batch tested is a commercial product

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

April 2002

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Cobalt diammonium EDTA

IUPAC Name:

Cobalt diammonium EDTA

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy (breeder: Harlan France S.A.R.L., Z.I. Le Malcourlet - R.N.9, 03800 Gannat, France)
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: 1.87 to 2.34 kilograms
- Housing: grid-bottomed metal cages suspended over trays measuring 45x51x69 cm
- Diet (e.g. ad libitum): STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK ad libitum troughout the study
- Water (e.g. ad libitum): drinking water supplied to each cage via a water bottle ad libitum
- Acclimation period: at least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): artifcial (fluorescent tubes), daily light/dark cycle of 12112 hours

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

few seconds

Observation period (in vivo):

at allocation; approximately 1, 24, 48 and 72 hours alter treatment.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

SCORING SYSTEM:
Con junctivae Value
1) Reddening of the palpebra) and bulbar conjunctivae
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individuai vessels not easily discernible 2
Diffuse, beefy red 3
2) Chemosis of the lids andlor nictitating membrane
No swelling 0
Any swelling above normal (including nictitating membranes) 1
Obvious swelling with partial eversion of the lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
3) Discharge (Lachrymation)
No discharge 0
Any amount different from normal (does not include small amount observed in
inner canthus of normal animals) 1
Discharge with moistening of the lids and hair just adjacent to the lids 2
Discharge with moistening of the lids and hair for a considerable area around the
eye 3
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of
these or combination of any thereof, iris stili
reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Cornea
1) Degree of opacity (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse area of opacity (other than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupi) barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
2)Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not eye irritant

Executive summary:

Method

The acute eye irritation of the test item was investigated in rabbits, according to the OECD guideline 405.

A 0.1 ml aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed 1, 24, 48, and 72 hours after dosing.

Results

No irritation at either the conjunctivae, iris or cornea (score of O) was recorded in any treated animai during the whole observation period (72 h). There was no indication of a systemic effect of treatment.Changes in body weight were not remarkable.

Conclusion

These results indicate that the test item has no effect on the eye of the rabbit.