Dialuminium zinc tetraoxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study (no information on systemic effects are given in the test report, no anesthetics or analgesics were used)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 April 2002

Deviations:

yes

Remarks:

no information on clinical signs or pain/distress are given in the test report, no anesthetics or analgesics were used

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

no information on clinical signs or pain/distress are given in the test report, no anesthetics or analgesics were used

GLP compliance:

yes (incl. QA statement)

Remarks:

GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES

Test material

Test material information

Constituent 1

Reference substance name:

Dialuminium zinc tetraoxide

EC Number:

235-101-0

EC Name:

Dialuminium zinc tetraoxide

Cas Number:

12068-53-0

Molecular formula:

ZnAl2xO(3x+1), x = 1 – 9

IUPAC Name:

dialuminum; zinc(2+); oxygen(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): D-PrisM
- Physical state: pale yellowish powder
- Analytical purity: 100%
- Composition of test material: zinc aluminate
- Lot/batch No.: PC080519/1
- Expiration date of the lot/batch: 01.06.2018
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste, Linxe, France
- Age at study initiation: 13 weeks
- Weight during study period: 2.46 - 3.00 kg
- Housing: individual
- Diet: SAFE-112, ad libitum
- Water: tap-water from public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1 h in 2 animals; the test substance was not washed out in the 3rd animal

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

1 female (initial test)
2 females (confirmatory test)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Remaining test item was rinsed with physiological saline in 2 animals
- Time after start of exposure: 1 h

SCORING SYSTEM: similar to Draize scoring system, supplemented with scoring for discharge and extent of opacity

Discharge:
No discharge - 0
Slight discharge (normal slight secretions in the inner corner to be taken into account) -2
Discharge with moistening of the eyelids and neighbouring hairs - 2
Discharge with moistening of the eyelids and large areas around the eye -3

Cornea: Extent of opacity:
Opaque area present but covering 1/4 or less - 1
Between 1/4 or 1/2 - 2
Between 1/2 and 3/4 - 3
Between 3/4 and the entire surface - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

The test item induced only weak reactions including redness of the conjunctivae in 2/3 animals and chemosis in 1/3 animals which were fully reversible within up to 72 or 48 h, respectively. No adverse effects on the cornea or iris were observed.

Other effects:

No information on clinical signs or pain/distress are reported.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

CLP: not classified