Nickel(2+) propionate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1998 to November 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

other: ECHA disseminated Dossier

Title:

ECHA disseminated Dossier of Nickel acetate (CAS 373-02-4)

Year:

2013

Bibliographic source:

ECHA disseminated Dossier of Nickel acetate (CAS 373-02-4), query date 2020-11-24

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nickel di(acetate)

EC Number:

206-761-7

EC Name:

Nickel di(acetate)

Cas Number:

373-02-4

Molecular formula:

C2H4O2.1/2Ni

IUPAC Name:

nickel(2+) diacetate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA.
- Age at study initiation: Adult
- Weight at study initiation: not reported
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 19-50%
- Air changes (per hr): 10-15 per hour
- Photoperiod: 12-h light/12-h dark photoperiod.

IN-LIFE DATES: not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

single application, washing of eye after 24 hours

Observation period (in vivo):

up to 7 days

Number of animals or in vitro replicates:

3

Details on study design:

Both eyes of each test animal were examined prior to testing to identify any pre-existing ocular irritation or corneal injury. Three rabbits (one male and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed. The test article was instilled into the conjunctival sac of the right eye of each animal, a minimum of 1 hour after preliminary examination. Following instillation, the eyelids were gently held together for one second to limit test article loss. The untreated left eye of each animal served as the control. Animals were examined twice daily. Body weights were measured prior to dosing. All animals were sacrificed at the end of the study duration. No necropsy examinations were performed.

REMOVAL OF TEST SUBSTANCE
- Washing: using physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: Ocular observations were conducted at 1, 24, 48 and 72 hours and up to 7 days after dosing. Eyes were scored using the EEC Ocular Evaluation Criteria, which is based on Draize (1959).

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Exposure to the test article produced irrititis in 3/3 test eyes at the 1-hour scoring interval.
The irititis resolved completely by 48 hours. Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval.
Conjunctival irritation resolved completely in all test eyes by study day 7.
Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was not considered to be clssified for eye irritation based on this in vivo study.