[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline-study performed under QAU and GLP (study was performed with just one animal, although the substance seems not to be corrosive)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(study was performed with just one animal, although the substance seems not to be corrosive)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc

EC Number:

238-262-5

EC Name:

[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc

Cas Number:

14320-04-8

Molecular formula:

C32 H16 N8 Zn

Details on test material:

- Physical state: solid
- Analytical purity: 96.8%
- Batch No.: Partie 77.86

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.6 kg
- Housing: singly
- Diet (ad libitum): Kliba 341
- Water (ad libitum): tap water
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of the animal

Amount / concentration applied:

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

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1 male rabbit

Details on study design:

The test article was placed in the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: according to OECD Guidline 405

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-48-72 hours post treatment

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-48-72 hours post treatment

Score:

0

Max. score:

2

Remarks on result:

other: no effects observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48-72 hours post treatment

Score:

0

Max. score:

3

Remarks on result:

other: no effects observed

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-48-72 hours post treatment

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Other effects:

In the area of application a blue staining of the conjunctivae and eyelashes by pigment or coloring of the test article was observed during the entire observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information