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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test item is the substance in water at 30g/l

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-6'-hydroxy-4'-methyl-2'-oxo-, inner salt and 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-1',6'-dihydro-2'-hydroxy-4'-methyl-6'-oxo-, chloride (1:1)
Molecular formula:
not applicable (reaction mass)
IUPAC Name:
Reaction mass of 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-6'-hydroxy-4'-methyl-2'-oxo-, inner salt and 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-1',6'-dihydro-2'-hydroxy-4'-methyl-6'-oxo-, chloride (1:1)
Test material form:
other: concentrated solution

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test System: Rabbit, Chbbibm: NZW (SPF)
Rationale: Recognized by the international guidelines as the recommended test system (e.g. OECD, EEC).
Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4 CH-4414 FOllinsdorf
Number of animals: 1 male / 2 females
Age at start of treatment: male : 14 weeks/ females: 15 weeks
Body weight at start of treatment: male : 2.5 - 2.7 kg / females: 2.8 kg
Identification: By unique cage number and corresponding ear tags
Acclimatization: Four days under test conditions after veterinary examination.
Allocation: Animal Numbers Male no. 13 Female nos. 14 - 15

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The test article was applied undiluted as delivered by the sponsor.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72h
Score:
ca. 0.33
Max. score:
0.67

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
the test item is not eye irritating
Executive summary:

Under the conditions of this experiment, HMDPY was found to cause a primary irritation score of: 1.17, when applied to the conjunctival sac of the rabbit eye.

A yellowish staining of the lidhairs of the treated eyes by pigment or coloring of the test article was observed during the entire study period.

Generally slight diffuse corneal opacity was observed in all animals after 1 hour of treatment.