Aluminium nitride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-05-23 to 2014-08-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium nitride

EC Number:

246-140-8

EC Name:

Aluminium nitride

Cas Number:

24304-00-5

Molecular formula:

AlN

IUPAC Name:

alumanylidyneamine

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Aluminium nitride Grade C
- CAS No.: 24304-00-5
- Physical state: solid
- color: white
- Analytical purity: 99%
- pH: 8 (50 g/l at 20°C)
- Lot/batch No.: 13174
- Expiration date of the lot/batch: not applicable
- Storage condition of test material: at room temperature, protected from light

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: 18 - 19 weeks old
- Weight at study initiation: > 2 kg
- Housing: ABS-plastic or Noryl rabbit cages, floor 4200 cm2, in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 0724), rich in crude fibre
- Water (e.g. ad libitum): ad libitum - Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test item was applied to the test site

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

72 hours, 24, 48 and 72-hours readings

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution and rinsed with physiological saline 0.9% NaCl after the examination.
- Time after start of exposure: 1 hour

SCORING SYSTEM: Grading System for Ocular Lesion

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

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

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

After the application into the eyes of three female NZW rabbits the test item produced slightly irritant but not corrosive effects in all animals (see Table 1 - Table 3). Neither mortalities nor significant clinical signs of toxicity were observed (see Table 4). Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal. Conjunctival redness and discharge were observed in all animals and conjuntival chemosis was observed in 2 out 3 animals. Signs of eye irritation are individually described in Table 1 - Table 3.

Any other information on results incl. tables

Table 1: Eye Irritation Scores - Animal No. 1

Observation	Time Post-Application Animal 1
	1(1h)		2(24h)		3(48h)		4(72h)
	T	C	T	C	T	C	T	C	Average Score (24, 48 and 72 hours)
Redness	1	0	1	0	1	0	0	0	0.67
Chemosis	0	0	0	0	0	0	0	0	0.00
Iris	0	0	0	0	0	0	0	0	0.00
cornea	0	0	0	0	0	0	0	0	0.00

t= test item; c= control

  Table 2: Eye Irritation Scores - Animal No. 2

Observation	Time Post-Application Animal 2
	1(1h)		2(24h)		3(48h)		4(72h)
	T	C	T	C	T	C	T	C	Average Score (24, 48 and 72 hours)
Redness	1	0	1	0	0	0	0	0	0.33
Chemosis	1	0	0	0	0	0	0	0	0.00
Iris	0	0	0	0	0	0	0	0	0.00
cornea	0	0	0	0	0	0	0	0	0.00

  Table 3: Eye Irritation Scores - Animal No. 3

Observation	Time Post-Application Animal 3
	1(1h)		2(24h)		3(48h)		4(72h)
	T	C	T	C	T	C	T	C	Average Score (24, 48 and 72 hours)
Redness	1	0	1	0	0	0	0	0	0.33
Chemosis	1	0	0	0	0	0	0	0	0.00
Iris	0	0	0	0	0	0	0	0	0.00
cornea	0	0	0	0	0	0	0	0	0.00

Table 4: Clinical Signs

Animal No. 1	Time Post-Application	Systemic Findings	Local Findings(apart from effects in Table 1.)
	1 hour	nsf	discharge grade 1
	24 hours	nsf	Nsf
	48 hours	nsf	Nsf
	72 hours	nsf	Nsf
Animal No. 2	Time Post-Application	Systemic Findings	Local Findings(apart from effects in Table 2.)
	1 hour	nsf	discharge grade 1
	24 hours	nsf	Nsf
	48 hours	nsf	Nsf
	72 hours	nsf	Nsf
Animal No. 3	Time Post-Application	Systemic Findings	Local Findings(apart from effects in Table 3.)
	1 hour	nsf	discharge grade 1
	24 hours	nsf	nsf
	48 hours	nsf	nsf
	72 hours	nsf	nsf

 nsf: no specific findings

Table 5: Absolute Body Weights (kg)

BODY WEIGHT (kg)
Animal No.	1	2	3
Start of Study	3.9	3.8	3.4
End of Study	4.0	3.9	3.5

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

In an in vivo acute eye irritation/corrosion study in Rabbits, Aluminium nitride Grade C was tested negative regarding irritation to the eye.

Executive summary:

In a primary eye irritation study 0.1 g of Aluminium nitride Grade C (99 % purity) was applied into the conjunctival sac of one eye of 3 female New Zealand White Rabbits, Crl: KBL (NZW). The undiluted test substance remained in the eye for 1 hour and was rinsed afterwards with physiological saline (0.9% NaCl). Control and treated Animals were observed for a period of 72 hours.

Under the conditions of the present study, a single ocular application of the test item to rabbits at a dose of 0.1 g produced slightly irritant effects in all animals, which were fully reversible within 72 hours in animal no. 1 and within 48 hours in animal no. 2 and no. 3. Neither mortalities nor significant clinical signs of toxicity were observed.

On the basis of the test results and in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008, the substance should be not classified.