Potassium 3-sulphopropyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 November - 02 December 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

yes

Remarks:

(only 4 days of acclimatisation)

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

Potassium 3-sulphopropyl methacrylate

EC Number:

250-466-6

EC Name:

Potassium 3-sulphopropyl methacrylate

Cas Number:

31098-21-2

Molecular formula:

C7H12O5S.K

IUPAC Name:

potassium 3-(methacryloyloxy)propane-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report) : (3-Sulfopropyl)-methacrylsäureester , K-Salz (SPM)
- Physical state : white powder
- Analytical purity : no data
- Lot/batch No. : no data

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 Fuellinsdorf , Switzerland
- Age at study initiation : approximately 14 weeks
- Weight at study initiation : 2,3 - 3,0 kg
- Housing : The animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet : rabbit maintenance diet (pelleted standard Kliba 23/341/1 , Klingentalmühle AG , 4303 Kaiseraugst , Switzerland) , ad libitum
- Water : tap water , ad libitum
- Acclimation period : 4 days

ENVIRONMENTAL CONDITIONS
- Temperature : 22°C +/- 2°C
- Humidity : 55% +/- 10%
- Air changes (per hr) : no data
- Photoperiod (hrs dark / hrs light) : 12/12

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:

clipped

Vehicle:

other: Polyethylene glycol (PEG 400) + Saline (70:30)

Controls:

other: the not-treated skin served as control site

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 1 g
- Concentration : 50% solution of the test substance in polyethylene glycol (PEG400) + Saline (70 : 30 parts)

VEHICLE
Polyethylene glycol (PEG 400) + Saline (70:30)

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 (1 male , 2 females)

Details on study design:

TEST SITE
- Area of exposure: 24 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.
- Type of wrap if used: patch of surgical gauze , covered with impermeable material

OBSERVATION TIME POINTS
The skin reaction of the treated skin site was observed 1h, 24h, 48h, and 72h after removal of the gauze patch

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 1h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

24 h

Score:

0.6

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

Irritation : (3-Sulfopropyl)-methacrylsäureester , K-Salz (SPM) showed no irritation , when applied to intact rabbit skin .
Corrosion : No destructions or irreversible alterations of the treated skin were observed . Thus it was concluded that no corrosion effect had occurred on the skin .

Other effects:

In the area of application no discoloration of the skin was observed which could be related to effects of the test material .

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

no classification according to Regulation (EC) 1272/2008 required

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 test material did not induce any relevant irritation or corrosion on the intact skin of rabbits. The test material was considered to be not irritating under the conditions of the test as the determined irritation scores did not meet the classification criteria according to Regulation (EC) 1272/2008.

Executive summary:

The skin irritation potential of the test substance was investigated in New Zealand White rabbits according to OECD TG404. 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 0.4 (Mean irritation index for intact skin). No classification according to Regulation (EC) 1272/2008 is required.