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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-11-25 - 1982-12-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
only 4 days of acclimatisation
Qualifier:
according to guideline
Guideline:
other: ETAD (ecological and toxicological association of the dye stuffs manufacturing industries) Methods 001-003 (1979)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(3-sulphonatopropyl)pyridinium
EC Number:
239-491-3
EC Name:
1-(3-sulphonatopropyl)pyridinium
Cas Number:
15471-17-7
Molecular formula:
C8H11NO3S
IUPAC Name:
1-(3-sulfopropyl)pyridin-1-ium
Details on test material:
- Name of test material (as cited in study report): 1- (3-Sulfopropyl)-Pyridinium-Betain (PPS)
- Substance type: organic salt
- Physical state: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: cages individually in stainless steel cages with automatic drinking water supply and cleaning system (Dipl. Ing. W. Ehret GmbH/Versuchstiertechnik, 7830 Mendingen, Germany).
- Diet (e.g. ad libitum): pelleted standard KLIBA 23/341/1 rabbit maintenance dies (Klingentalmuehle AG, 4303 Kaiseraugust, Switzerland)
defined for acceptable contaminant level, ad libitum.
- Water (e.g. ad libitum): tap water ad libitum (water quality according to the requirements of the "schweiz. Lebensmittelbuch".
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IDENTIFICATION: individually by numbered ear tags (Eisenhut Vet. AG, 4123 Allschwil, Switzerland) and cage number.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: back and flanks of each rabbit were closely clipped with electric clippers
Vehicle:
other: polyethylene glycol (PEG400) + Saline (70 : 30 parts)
Controls:
other: the not-treated skin served as control site
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 gram
- Concentration (if solution): 50% solution of the test substance in polyethylene glycol (PEG400) + Saline (70 : 30 parts)

VEHICLE
- Concentration (if solution): polyethylene glycol (PEG400) + Saline (70 : 30 parts)
Duration of treatment / exposure:
The bandages and gauze patches remained in place for 4 hours. The animals were not restrained during this period.
Observation period:
72 hours
Number of animals:
3 (2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: Twenty four hours before treatment the back and flanks of each rabbit were closely clipped with electric clippers, exposing an area of skin of approximately 10 X 10 cm.

SCORING SYSTEM:
1. Erythema and Eschar formation
no erythema = 0
very light erythema (barely detectable) = 1
well-defined erythema = 2
moderate to severe erythema = 3
severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4
total possible erythema score: 4
2. Oedema
no oedema = 0
very light oedema (barely perceptible) = 1
light oedema (edges of area well defined by definitive raising) = 2
moderate oedema (raised approximately 1 mm) = 3
severe oedema (raised more than 3 mm and extending beyond area of exposure) = 4
total possible oedema score: 4

The skin reaction of the treated site was observed 1 hour/ 48 / 72 hours following removal of bandages and gauze patch.
In addition the corrosion effect to the skin of the rabbits was recorded and the number of affected animals was registered.
Mortality and clinical symptoms were monitored once daily.

SACRIFICE AND NECROPSY
Termination and post-mortem examination: the study was terminated 72 hours after substance application. All rabbits were killed by an intravenous injection of T61 (Hoechst) in the ear vein. Due to the results obtained, no macroscopical organ examination was indicated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Index of colouration
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
1-(3-Sulfopropyl)-Pyridinium-Betain (PPS) showed no irritation, when applied to intact rabbit skin.
No destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that no corrosion effect had occurred on the skin. In the area of application no discolouration f the skin was observed which could be related to compound effects. No acute toxicological signs were observed in the animals during the test period.
Other effects:
No other effects were reported.

Any other information on results incl. tables

Table 1: Skin irritation scores

Skin irritation scores
Time period Animal / Sex Erythema Oedema
Intact Abraded Intact Abraded
After 1 hour 101H 1 - 0 -
102M 1 - 0 -
103F 1 - 0 -
After 24 hours 101M 0 - 0 -
102M 0 - 0 -
103F 0 - 0 -
After 48 hours 1.01M 0 - 0 -
  1.02M 0 - 0 -
  1.03F 0 - 0 -
After 72 hours 101M 0 - 0 -
  102M 0 - 0 -
  103F 0 - 0 -

Table 2: Primary skin irritation index

PRIMARY SKIN IRRITATION INDEX
SELECTED OBSERVATIONS INTACT SKIN ABRADED SKIN
After1 hour 1.0 -
After24hours 0.0 -
After48hours 0.0 -
After 72hours 0.0 -
Mean irritation index 0.2 -
primary skin irritation index  0.2 -

Score according to :

0 to 0.5 (none)

0.6 to 3.0 (slight)

3.1 to 5.0 (moderate)

5. to 8.0 (marked)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The study was performed according to the OECD Guideline 404 with only negligible deviations and even though no information was available whether it was performed according to the good laboratory practice principles, it is considered to be of high quality (reliability Klimisch 2). The criteria of validity of the test system are fulfilled. The test material did not induce any irritation or corrosion on the intact skin of rabbits. The test material was considered to be not irritating under the conditions of the test.
Executive summary:

The skin irritation potential of the test substance was investigated in New Zealand White rabbits according to OECD TG404 (Claus and Ullmann, 1982). The test substance (1 gram of a 50% dilution of the test substance in polyethylene glycol/water) was applied occlusively to the intact skin for 4 hours; thereafter the skin reactions were monitored for 72 hours. Under the conditions of this experiment the test material was found to cause no irritation. In the area of application no discoloration of the skin was observed in the rabbits which could be related to compound effects. No corrosion effect had occurred on the skin at each measuring interval. The calculated primary irritation index was found to be 0.2 (Mean irritation index for intact skin).