Dichromium nitride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-12-12 to 2018-02-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2017-10-09

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2017-05-08

Test material

Test material information

Constituent 1

Reference substance name:

Dichromium nitride

EC Number:

235-002-2

EC Name:

Dichromium nitride

Cas Number:

12053-27-9

Molecular formula:

Cr2N

IUPAC Name:

dichromioamine

Test material form:

solid: particulate/powder

Details on test material:

- State of aggregation: grey solid powder
- Crystal structure: hexagonal crystals
- Particle size distribution: D (v, 0.5) = 1.98 μm

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +10 °C to +25 °C, in the closed original container in a dry, well-ventilated place.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Age at study initiation: approx. 7 - 8 months
- Weight at study initiation: 3.7 to 4.7 kg
- Housing: kept singly in cages with dimensions of 823 mm x 660 mm x 500 mm (Scanbur, Denmark)
- Diet (ad libitum): commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH)
- Water (ad libitum): tap water
- Acclimation period: at least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 °C (maximum range)
- Relative humidity: 30 % - 70 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

1, 24, 48 and 72 hours after the administration

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

INITIAL AND CONFIRMATORY TEST
The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in the animal treated in the preliminary test, 2 further animals were employed 24 hours after start of the initial test.

USAGE OF ANAESTHETICS AND SYSTEMIC ANALGESICS
Sixty minutes prior to test item administration, 0.01 mg Buprenovet®/kg bw were administered by subcutaneous (s.c.) injection to all animals to provide a therapeutic level of systemic analgesia to avoid or minimize pain and distress.
Five minutes prior to the test item administration, two drops of Conjuncain®EDO, a topical anaesthetic, were applied to each eye of all animals, to the right eye, in which the test item was to be applied, and to the left eye, which served as control.
Eight to 9 hours after administration, Acticam® 0.5 mg/kg, s.c. was administered to provide a continued therapeutic level of systemic analgesia.

REMOVAL OF TEST SUBSTANCE
- Washing: eyes were rinsed with 20 mL 0.9 % aqueous NaCl solution
- Time after start of exposure: 1 hour

SCORING SYSTEM: according to the Draize scale and a scale scoring the degree of staining (Fluorescein-test)

TOOL USED TO ASSESS SCORE: slit lamp and fluorescein
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24, 48 and 72 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.

OBSERVATIONS
- body weight: at the beginning and at the end of the study.
- behaviour and food consumption were monitored
- any adverse systemic effects were recorded

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: slight corneal opacity was observed at the 1 hour observation.

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- slight corneal opacity (grade 1) was observed in one animal 1 hour after administration. The effect was fully reversible within 24 hours after application of the test item.
- fluorescein test performed 24, 48 and 72 hours after administration did not reveal any changes.
- irises and the conjunctivae were not affected by administration of the test item.

Other effects:

- Lesions and clinical observations: no systemic intolerance reactions were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the eyes.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as eye irritant.