Reaction product of soluble nickel salt, cobalt salt, manganese salt with alkalines

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Hypothesis for read-across: Cobalt dihydroxide and nickel dihydroxide are the main components of the target UVCB-substance, and considered the major drivers for adverse effects based on its properties and relative quantity in the substance. For read-across purpose, data from the constituents (cobalt dihydroxide and nickel dihydroxide) of the target UVCB-substance is used in the REACH registration. Well documented with individual Draize Scoring Scheme - The observation time was only until 72 hours after application of the test item. this observation time was not long enough to evaluate the reversibility of the irritating effect, but it could be observed that the irritating effect got better with the time passing. - The eyes were not examined 1 hour after application of the test item. - There was no statement if effect 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

Test material information

Constituent 1

Reference substance name:

Cobalt dihydroxide

EC Number:

244-166-4

EC Name:

Cobalt dihydroxide

Cas Number:

21041-93-0

Molecular formula:

CoH2O2

IUPAC Name:

cobalt(2+) dihydroxide

Details on test material:

- Name of test material (as cited in study report): Cobalt hydrate powder
- Physical state: Fine, light pink 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

Results

Results 1

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.

Results 2

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.

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

1.67

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: Eyes were not rinsed after application of the test item.

Results 4

Irritation parameter:

chemosis 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.

Results 5

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.

Results 6

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.

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

2

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Eyes were not rinsed after application of the test item.

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Eyes were not rinsed after application of the test item.

Results 9

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.

Results 10

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.

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

2.67

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Eyes were not rinsed after application of the test item.

Results 12

Irritation parameter:

chemosis 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.

Irritant / corrosive response data:

Following application of cobalt hydrate powder without a rinse, no corneal opacity or iritis was noted at any time diuring the study. moderate to severe conjunctivitis was noted in all three rabbits and blistering of the lower lids was noted in two rabbits at the 24 to 48-hour reading. Mild to moderate conjunctivitis was generally noted in all of the rabbits at the 72-hour reading (for results see "Overall irritation/ corrosion results" above).
Following a 200 ml rinse 30 seconds after application of cobalt hydrate powder, no corneal opacity or iritis was noted during the study. At the 24-hour reading irritative effects noted included mild to moderate conjunctival erythema in all three rabbits, with bistering of the lower lids in one rabbit. At the 48-hour reading, mild conjunctival erythema was noted in one rabbit. No irritative effects were noted at the 72-hour reading (see "Remarks on results including tables and figures" for results; table 1).

Any other information on results incl. tables

Table 1. Eye irritation scores in albino rabbits following application of 0.1 gram of cobalt hydrate powder followed in 30 seconds by irrigation with 200 ml 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	1	2		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	0.67	2		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	0.33	1		Eyes rinsed after 30 seconds
Chemosis score	Mean animal #6	24, 48, and 72 hours	0	0		Eyes rinsed after 30 seconds

Justification for read-across: Cobalt dihydroxide and nickel dihydroxide are the main components of the target UVCB-substance, and considered the major drivers for adverse effects based on its properties and relative quantity in the substance. For read-across purpose, data from the constituents (cobalt dihydroxide and nickel dihydroxide) of the target UVCB-substance is used. According to section 1.5, annex XI of regulation (EC) 1907/2006, such studies do not need to be conducted, since adequate data from structurally analogous substances are available. Therefore read-across from these compounds is justified.

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 Category 2.