Manganese, [[2,2',2''-[nitrilotris[2,1-ethanediyl(nitrilo-.kappa.N)methylidyne]]tris[phenolato-.kappa.O]](3-)]-, (OC-6-22)-

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: OECD guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted April 24, 2002

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:

-

EC Number:

479-540-8

EC Name:

-

Cas Number:

61007-89-4

Molecular formula:

C27 H27 Mn N4 O3

IUPAC Name:

manganese(3+) 2-[({2-[bis(2-{[(2-oxidophenyl)methylidene]amino}ethyl)amino]ethyl}imino)methyl]benzen-1-olate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400, Chatillon sur Chalaronne, France
- Age at study initiation: males: 13 weeks; females: 14 - 15 weeks
- Weight at study initiation: male: 2760 g; females: 2581 g and 2486 g
- Housing: Individually in stainless steel cages
- Diet: standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: 05.11. - 28.11.2002

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

7 days (examination of the eyes after 1 hour and 1, 2, 3, 7, 10 and 14 days after instillation of the test substance)

Number of animals or in vitro replicates:

1 male and 2 female NZW rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
The treated eyes were not rinsed after instillation.

SCORING SYSTEM:
According to the grading system given in the OECD guideline 405

TOOL USED TO ASSESS SCORE:
Eye examinations were made with a Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean (24, 48, 72h)

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean (24, 48, 72h)

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean (24, 48, 72h)

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean (24, 48, 72h)

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 10 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean (24, 48, 72h)

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean (24h, 48h, 72h)

Score:

0.89

Max. score:

3

Reversibility:

fully reversible within: 10 days

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean (24, 48, 72h)

Score:

0

Max. score:

4

Irritant / corrosive response data:

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening of the conjunctivae was observed in all animals from 1 to 48 hours after treatment. This effect continued to be observed in one animal up to the 72-hour examination and in another animal up to the 7-day examination. Slight swelling of the conjunctivae was apparent in all animals at the 1-hour examination. Slight reddening of the sclerae was present in one animal from 1 to 24 hours after treatment and in another animal at the 1-hour examination only. Prolonged scleral reddening (slight) was noted in the remaining animal from 1 hour to 14 days after treatment. No abnormal findings were observed in the treated eye of any animal 17 days after treatment, the end of the observation period for all animals.

Other effects:

COLORATION
No staining of the treated eyes by the test item was observed. Green remnants of the test item were observed in the eye or conjunctival sac of all animals 1 hour after treatment.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU