Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well documented with individual Draize Scoring Scheme Minor deviations from guideline with no effect on the results: - There were no observations made at 1 hour. - It was not stated if effects other than ocular were observed. - The purity and stability of the test item was missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, adopted 1987-02-24
Deviations:
yes
Remarks:
, see "rational for reliability"
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cobalt carbonate
EC Number:
208-169-4
EC Name:
Cobalt carbonate
Cas Number:
513-79-1
Molecular formula:
CH2O3.Co
IUPAC Name:
lambda2-cobalt(2+) carbonate
Details on test material:
- Name of test material (as cited in study report): Cobalt carbonate powder
- Physical state: Fine, light purple powder with a slight odour
No further information on the test material was stated.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sweetwater farms
No further information on the test animals was stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the undiluted sample was applied to the right eye of each of six rabbits. The left eye of all rabbits was untreated and served as a cntrol.
No further information on amount/concentration applied was stated.



Duration of treatment / exposure:
In 3 of 6 rabbits the test material was left in the eye for 30 seconds . For the remaining three rabbits no statement regarding duration of treatment/exposure was made.
Observation period (in vivo):
24, 48 and 72 hours after application of the test material
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were irrigated following application with 200 ml of lukewarm tap water. The treated eyes of the three remaining received no further treatment.
- Time after start of exposure: Irrigation after 30 seconds

SCORING SYSTEM: Scoring of irritative effects was according to the method of Draize in which corneal, iris and conjunctival effects are scored separately. In this scoring system, injuries to the cornea and iris may represent as much as 80 percent of the total score. Cornea and iris scores are heavily weighted because of their essential role in vision.
No further information on the study design was stated.

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:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Eyes were not rinsed after application of the test item.
Irritant / corrosive response data:
At the 24 to 48-hour readings following application of cobalt carbonate powder without a rinse, mild to moderate conjunctivitis in all rabbits was noted. All irritative effects subsided by the 72-hour reading (for results see "Overall irritation/ corrosion results" above).
After application of cobalt carbonate powder followed after 30 seconds with a 200 ml rinse, irritative effects at the 24-hour reading included mild conjunctival erythema in two rabbits. No irritative effects were noted at the 48 and 72-hour observation intervals (for results see "Remarks on results including tables and figures"; table 1).

Any other information on results incl. tables

Table 1. Eye irritation scores in New Zealand White rabbits following application of 0.1 gram of cobalt carbonate powder followed in 30 seconds by irrigation with 200 mls of lukewarm tap water

Irritation parameter

Basis

Time point

 

Max. Score

Reversibility

Remarks

Cornea score

Mean animal #4

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Iris score

Mean animal #4

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Conjunctivae score

Mean animal #4

24, 48, and 72 hours

0.33

1

 

Eyes rinsed after 30 seconds

Chemosis score

Mean animal #4

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Cornea score

Mean animal #5

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Iris score

Mean animal #5

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Conjunctivae score

Mean animal #5

24, 48, and 72 hours

0.33

1

 

Eyes rinsed after 30 seconds

Chemosis score

Mean animal #5

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Cornea score

Mean animal #6

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Iris score

Mean animal #6

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Conjunctivae score

Mean animal #6

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Chemosis score

Mean animal #6

24, 48, and 72 hours

0

0

 

Eyes rinsed after 30 seconds

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The following classification is based on the results obtained without rinsing the eyes after application.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is classified as not irritating.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as not irritating.