Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Jul 1993 - 9 Aug 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

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:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates

EC Number:

309-916-8

EC Name:

Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates

Cas Number:

101357-19-1

Molecular formula:

Reaction mass of C25 H30 N3. P Moy Wz O40 (y +z = 12) , C24 H28 N3. P Moy Wz O40 (y +z = 12) and C23 H26 N3. P Moy Wz O40 (y +z = 12)

IUPAC Name:

Reaction mass of [4-[bis[4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates, [4-[[4-(dimethylamino)phenyl]-[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates and [4-[bis[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates

Test material form:

solid: nanoform, no surface treatment

Details on test material:

Product Number: 0345H
Batch Number: 931756

Nanoform details
Shape
Shape Category: spheroidal
Shape: spherical
Pure Shape: Yes
Typical Composition: ≤100%
range: >0; ≤100%
Particle size distribution & range
Shape Category: spheroidal
Percentile D10, typical value: 30nm
Percentile D10, range: ≥10; ≤50nm
Percentile D50, typical value: 45nm
Percentile D50, range: ≥30; ≤100nm
Percentile D90, typical value: 60nm
Percentile D90, range: ≥45; ≤150nm
Fraction in size range 1-100nm:≥50; ≤100%
Crystallinity
structure: Amorphous
Pure structure: Yes
Specific Surface Area
Typical specific surface area: ca. 40m2/g
Range: ≥10; ≤200m2/g
Skeletal density: 1.8 g/cm3
Surface Functionalisation/treatment
surface treatment applied no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0345H/931756
- Storage condition of test material: room temperature
- Physical Appearance: very dark blue powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 – 16 weeks
- Weight at study initiation: 2.54 – 2.84 kg
- Housing: metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 56 - 75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (or 88mg)

Observation period (in vivo):

1, 24, 48 and 72 hours; 4 7 14 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): N/A

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

not fully reversible within: 21

Remarks:

days

Remarks on result:

probability of moderate irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 21

Remarks:

days

Remarks on result:

probability of moderate irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 4

Remarks:

days

Remarks on result:

not determinable

Remarks:

animal sacrificed after 4 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 21

Remarks:

days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 21

Remarks:

days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 4

Remarks:

days

Remarks on result:

positive indication of irritation

Remarks:

animal sacrificed after 4 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 21

Remarks:

days

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 21

Remarks:

days

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 4

Remarks:

days

Remarks on result:

positive indication of irritation

Remarks:

animal sacrificed after 4 days

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

not fully reversible within: 21

Remarks:

days

Remarks on result:

probability of moderate irritation

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 21

Remarks:

days

Remarks on result:

probability of moderate irritation

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 4

Remarks:

days

Remarks on result:

not determinable

Remarks:

animal sacrificed after 4 days

Any other information on results incl. tables

	animal #1				animal #2				animal #3
	24 h	48 h	72 h	mean  animal #1	24 h	48 h	72 h	mean  animal #2	24 h	48 h	72 h	mean animal #3	mean
A - Redness	2	2	3	2.3	2	2	2	2	2	2	2	2	2.1
B - Chemosis	2	2	2	2	2	2	2	2	2	2	2	2	2
D - Iris	1	1	1	1	1	1	1	1	1	1	1	1	1
E - Degree of Opacity	1	2	2	1.7	1	1	2	1.3	1	1	1	1	1.3

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test item is irritant to rabbit eye.