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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

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:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

100 mg, powder

Controls:

no

Amount / concentration applied:

100 mg, powder

Duration of treatment / exposure:

Single ocular dose of 100 mg test substance with a 7 day observation period.

Observation period (in vivo):

seven days maximum

Number of animals or in vitro replicates:

3

Details on study design:

no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: score over 3 days

Score:

ca. 1.4

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: For more details see table below

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean score over 2 days

Score:

ca. 0.8

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: For more details see table below

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: score over 4 days

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: For more details see table below

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 day

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: For more details see table below

Irritant / corrosive response data:

Corneal opacity developed in one rabbit but was resolved by day seven. Dulling of the normal lustre of the cornea was seen in the other two rabbits at one hour only. Transient iridial inflammation was seen in one rabbit. A diffuse crimson colouration of the conjunctivae accompanied by obvious
swelling of the eyelids was seen in all three rabbits. These reactions had resolved three to four days after instillation. The eyes of all 3 animals were normal by day seven after instillation.

Other effects:

no data

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
Conjunctiva/redness	1,6	1	1,6	2	3	0
conjunctiva/chomosis	1	0,3	1	2	2	0
cornea	1,3	0	0	2	4	0
iris	0,3	0	0	1	1	0

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

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Temporary corneal opacification, transient iridial inflammation and slight to well defined conjunctival irritation were evident. All reactions had resolved seven days after instillation of the test material and were not sufficient to warrant classification irritating to the eyes.

Executive summary:

Corneal opacity developed in one rabbit but was resolved by day seven. Dulling of the normal lustre of the cornea was seen in the other two rabbits at one hour only. Transient iridial inflammation was seen in one rabbit. A diffuse crimson colouration of the conjunctivae accompanied by obvious swelling of the eyelids was seen in all three rabbits. These reactions had resolved three to four days after instillation. The eyes of all 3 animals were normal by day seven after instillation.