Nickel dinitrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03/06/2003-24/06/2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted guidelines with some limitations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

Environmental parameters: A relative humidity of 72% was recorded in the course of this study rather than 70% (maximum limit) as stated in the experimental protocol,
A temperature of 25°C was recorded in the course of this study rather than 23°C (maximum limit) as stated in the experimental protocol.

These deviations did not in any event affect the performance and the results of this study.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Nickel nitrate cryst 6H20

IUPAC Name:

Nickel nitrate cryst 6H20

Constituent 2

Reference substance name:

Nickel dinitrate

EC Number:

236-068-5

EC Name:

Nickel dinitrate

Cas Number:

13138-45-9

Molecular formula:

Ni(NO3)2

IUPAC Name:

nickel(2+) dinitrate

Details on test material:

- Name of test material (as cited in study report): NICKEL NITRATE CRYST 6H20
- Physical state: solid powder
- Lot/batch No.: 8115 TQ
- Storage condition of test material: ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMAL
- Source: Elevage de Gérome (Quartier Labaste - 40260 Linxe)
- Weight at study initiation: 2.19-2.23 kg
- Housing: individual cage
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-25
- Humidity (%): 58-72

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye of same animals

Amount / concentration applied:

0.1g

Duration of treatment / exposure:

not reported

Observation period (in vivo):

1, 24, and 48 hours

Number of animals or in vitro replicates:

1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Maxiumum Eye Irritation Index (I.O. Max)

Basis:

animal: A5362

Time point:

other: Through day 22

Score:

>= 13 - <= 82

Max. score:

82

Reversibility:

not fully reversible within: D21 (end of observation period)

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: A5362

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 22 days

Results 3

Irritation parameter:

iris score

Basis:

animal: A5362

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Remarks:

enanthema (rash)

Basis:

animal: A5362

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 22 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal: A5362

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 22 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal: A5362

Time point:

48 h

Score:

3

Reversibility:

not fully reversible within: 22 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal: A5362

Time point:

72 h

Score:

3

Reversibility:

not fully reversible within: 22 days

Irritant / corrosive response data:

Moderate to significant eye effects that were partially reversible were noted, namely:
- at the level of the conjunctiva: a moderate enanthema noted 1 hour after the instillation of the product and still noted at the end of the observation period (D21) (mild intensity), associated with a significant chemosis, noted 1 hour after the instillation of the product and still noted at the end of the observation period (D21) (moderate intensity),
- at the level of the cornea: a moderate opacity, noted 24 hours after the instillation of the product and still noted at the end of the observation period (D21) (mild intensity),
- at the level of the iris: mild congestion was noted from the 1st to the 5th day, followed significant congestion from the 6th to the 17th day of the study.
Furthermore, these effects are accompanied by a purulent secretion requiring rinsing with physiological solution from the 2nd to 17th day of the study.