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Toxicological information

Eye irritation

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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:
other: GLP guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: 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

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: average (24, 48 and 72 hours)
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness (grade 1) was observed at 24 and 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: average (24, 48 and 72 hours)
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness (grade 1) was observed at 24 hours
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: average (24, 48 and 72 hours)
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness (grade 1) was observed at 24 hours
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
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 [9], the substance should be not classified.