Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

no data

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate

EC Number:

411-760-1

EC Name:

Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate

Cas Number:

116633-53-5

Molecular formula:

C18 H42 Mn2 N6 O3 . 2 F6 P

IUPAC Name:

dimanganese(4+) bis(1,4,7-trimethyl-1,4,7-triazonane) bis(hexafluoro-λ⁵-phosphanuide) hydrate trioxidandiide

Details on test material:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

other: distilled water

Controls:

no

Amount / concentration applied:

0.5 g test substance moistened with 0.5 ml distilled water

Duration of treatment / exposure:

4 hours

Observation period:

Maximum of four days

Number of animals:

3 rabbits

Details on study design:

no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 30 minutes after removal of the dressing

Max. score:

1

Reversibility:

other: No reactions were seen at the 24 hour assesment in this rabbit or in either of the other two rabbits.

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 30 minutes after removal of the dressing

Max. score:

1

Reversibility:

other: No reactions were seen at the 24 hour assesment in this rabbit or in either of the other two rabbits.

Irritant / corrosive response data:

no data

Other effects:

observations: none

Any other information on results incl. tables

If 3 animals or less	Mean score * Animal no			maximum value	Maximum duration of any effect (days)	Maximum value at the end of the observation period
	1	2	3
erythema/eschar	0	0	0	0	0	0
oedema	0	0	0	0	0	0

*Calculated on the basis of the scores at 24, 48 and 72 hours for each animal

OBSERVATIONS: none

COMMENTS: Very slight dermal reactions (grade 1 erythema and oedema) were seen in one rabbit

30 minutes after removal of the dressings. No reactions were seen at the 24 -hour assessment in this rabbit

or in either of the other two rabbits.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information very slight dermal reaction in one animal only Criteria used for interpretation of results: EU

Conclusions:

The material does not warrant classification as skin irritant.

Executive summary:

Very slight dermal reactions (grade 1 erythema and oedema) were seen in one rabbit 30 minutes after removal of the dressings. No reactions were seen at the 24 -hour assessment in this rabbit or in either of the other two rabbits. Based on these results, a corrosivity test was not conducted.