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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22.10. - 06.12.2002

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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted July 17, 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Sclentifique des Dombes, F-01400, Chatillon sur Chalaronne, France
- Age at study initiation: males: 12 - 13 weeks; females: 11 weeks
- Weight at study initiation: male: 1965 g; females: 1965 g and 2026 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: 22.10. - 31.10.2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: 0.5 g test substance moistened with 0.1 mL

Duration of treatment / exposure:

4 hrs

Observation period:

3 days

Number of animals:

1 male and 2 female NZW rabbits

Details on study design:

TEST SITE
- Area of exposure: 10 cm x 10 cm, left flank
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
The skin reactions were evaluated 1 hour and 1, 2 and 3 days after removing the gauze patches according to the OECD scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean (24, 48, 72 h)

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean (24, 48, 72 h)

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.

Other effects:

COLORATION
No staining by the test item of the treated skin was observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information