Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin 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 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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 kg / females: 2.3 - 2.4 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

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The test article was applied undiluted as delivered by the sponsor
Duration of treatment / exposure:
The duration of treatment was 4 hours
Observation period:
Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the following numerical scoring system.
The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
ca. 0.33
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
ca. 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
the test article (HMDPY) is classified as not irritant to the rabbit skin.
Executive summary:

Under the conditions of this experiment, HMDPY was found to cause a primary irritation score of 0.33, when applied to healthy intact rabbit skin.

Local signs (mean values from 1 hour to 72 hours) consisted of grade 1.25 erythema and grade 0.25 edema.

In the area of application, a yellow staining of the treated skin by pigment or coloring of the test article was observed until termination of test.

No corrosive effect occurred on the treated skin of any animal at each measuring

interval.

the test article (HMDPY) is classified as not irritant to the rabbit skin.