Nickel bis(2-ethylhexanoate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April-May 2015

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Nickel bis(2-ethylhexanoate)

EC Number:

224-699-9

EC Name:

Nickel bis(2-ethylhexanoate)

Cas Number:

4454-16-4

Molecular formula:

C8H16O2.1/2Ni

IUPAC Name:

nickel(2+) bis(2-ethylhexanoate)

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

Identification: Nickel 2-ethylhexanoate
Batch n° L7282
Composition : 16.02%w/w Ni
Purity ≥ 94% w/w
Impurities : Nickel acetate (EC n° 239-086-1) ≤ 6% w/w

Test system

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

The test item was previously out on a gauze which was applied on the eye to cover the entire surface of the cornea. The test item was applied for 10 seconds and then rinsed from the eye with 20 mL of physiological saline at ambient temperature.

Observation period (in vivo):

Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Value:

0

Remarks on result:

other: maximal mean score = 0.0 corresponding to ICE class I

Results 2

Irritation parameter:

fluorescein retention score

Value:

2.3

Remarks on result:

other: maximal mean score = 2.3 corresponding to ICE class III

Results 3

Irritation parameter:

corneal swelling 

Value:

8

Remarks on result:

other: maximal mean = + 8% corresponding to ICE class II

Other effects / acceptance of results:

Corneal opacity: maximal mean score = 0.0 corresponding to ICE class I
Fluorescein retention: maximal mean score = 2.3 corresponding to ICE class III
Corneal swelling: maximal mean = + 8% corresponding to ICE class II
Combination of the 3 endpoints: 1 x III, 1 x II, 1 x I

Any other information on results incl. tables

The combination of the 3 endpoints for the positive control, sodium hydroxide, was 3 x IV. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.

The combination of the 3 endpoints for the negative control, physiological saline, was 3 x I. Therefore the negative control as 'No category' as expected.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive/severe irritant

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In accordance with Regulation EC 1272/2008, the test item does not have to be classified in category 1 'Irreversible effects on the eye'.

Nickel 2-ethylhexanaote does not have to be classified also R41 'Risk of serious damage to eyes' according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45.

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