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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.10. - 16.12.2002

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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: Males: 9 weeks, females: 13 weeks
- Weight at study initiation: Males: 244.8 -260.6 g; females: 182.4 - 216.5 g
- Housing: In groups of five per sex in Makrolon type-4 cages during acclimation; individually in Makrolon type 3 cages during treatment and observation
- Diet: standard diet, ad libitum
- Water: community tap water, ad libitum
- Acclimation period: 7 days, under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30-70 %
- Air changes (per hr): 10 -15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: from 02.10. - 23.10.2002

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: on the back of each animal
- % coverage: 10 % of the total body surface
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Concentration: 0.5 g/mL

VEHICLE
- Amount applied: 4 mL/kg bw

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality/Viability: Daily during acclimatization and twice daily during days 1 -15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No systemic signs of toxicity were observed during the study period. A slight green-yellow staining was present at the test site of all animals from day 2 to 7.

Gross pathology:

No macroscopic findings were observed at necropsy.