Potassium 3-sulphopropyl methacrylate

Endpoint summary

Description of key information

Skin irritation: in vivo study, New Zealand White rabbits m/f, occlusive, clipped, 50% solution, 4h exposure (OECD 404): not irritating

Eye irritation: in vivo study, New Zealand White rabbits m/f, 0.1 ml unchanged, no wash-out (OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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)

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

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.

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.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 1h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

24 h

Score:

0.6

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

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 .

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: ETAD (Ecological and toxicological association of the dye stuffs manufacturing industry, Methods 001-003 (1979)

Qualifier:

according to guideline

Guideline:

other: VCI (Verband der chemischen Industrie, BRD) Sicherheitsdatenblatt

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG , 4414 Fuellinsdorf , Switzerland
- Age at study initiation: appr. 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 (e.g. ad libitum): rabbit maintenance diet (pelleted standard Kliba 23/341/1 (Klingentalmühle AG , 4303 Kaiseraugst , Switzerland) , ad libitum
- Water (e.g. ad libitum): tap water , ad libitum
- Acclimation period: 4 days

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

Other:
- Identification: individually by numbered ear tags (Eisenhut Vet AG, 4123 Allschwil, Switzerland) and cage numbers.

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/rabbit

Duration of treatment / exposure:

single application into the conjunctival sac of the left rabbit eye, without rinsing out.

Observation period (in vivo):

1/ 24/ 48/ 72 hours after treatment

Number of animals or in vitro replicates:

3 (1 male / 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
not done

SCORING SYSTEM:

Cornea

A) opacity and the degree of opacity (most dense area scored).
No opacity = 0
Scattered or diffuse area (details of iris clearly visible) = 1
Easily discernible translucent areas, details of iris slightly obscured =2
Opalescent areas, no details of iris visible, size of pupil barely discernible = 3
Opal opacity, iris invisible = 4

B) area of cornea involved
No area involved = 0
One quarter (or less, but not 0) = 1
more than one quarter, less than half = 2
greater than half, but less than three quarters = 3
greater than three quarters up to the whole area = 4
A x B x 5 Total maximum = 80

Iris

A. Values
Normal = 0
Fold above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) Iris still reacting to light (sluggish reaction is positive) = 1
No reaction to light, haemorrhage, gross destruction (any or all of these) = 2
A x 5 = Total Highest number = 10

Conjunctiva

A) Redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
Vessels normal = 0
Vessels definitively injected more than normal = 1
More diffuse, deeper crimson red, individual vessels not easily discernible = 2
Diffuse beefy red = 3

B) Chemosis
No swelling = 0
Any swelling above normal (includes nictitating membrane) = 1
Obvious swelling with partial eversion of the lids = 2
Swelling with lids about half closed = 3
Swelling with lids about half closed to completely closed = 4

C) Discharge
No discharge = 0
Any amount different from normal (does not include small amounts observed in the inner canthus of normal animals) = 1
Discharge with moistening of lids and hairs just adjacent to lids = 2
Discharge with moistening of the lids and hairs, and considerable area around the eye = 3
(A + B + C) x 2 Total maximum = 20

In addition the coloration of the sclera/cornea was recorded in connection with the colour of the test material.
The total score for the eye is the sum of all points for cornea, iris and conjunctiva.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

3.8

Reversibility:

other: not applicable

Irritation parameter:

other: mean reaction score

Basis:

mean

Time point:

other: 1 hour

Score:

8.6

Reversibility:

fully reversible

Irritation parameter:

other: mean reaction score

Basis:

mean

Time point:

24 h

Score:

5.3

Reversibility:

fully reversible

Irritation parameter:

other: mean reaction score

Basis:

mean

Time point:

48 h

Score:

1.3

Reversibility:

fully reversible

Irritation parameter:

other: mean reaction score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

other: animal 1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

iris score

Basis:

other: animal 1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.75

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.75

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.75

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.25

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.25

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Time point mean over 1,24,48 and 72h

Irritant / corrosive response data:

(3-Sulfopropyl)-methacrylsäureester , K-Salz (SPM) showed no irritation when applied to the rabbit eye mucosa.
No discoloration of the cornea and conjunctivae was observed in the rabbits during the entire test period which could be related to effects of the test material.
No corrosion effect was observed at each of the measuring intervals.
No acute toxicological signs were observed in the test animals during the test period.

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 TG405 without 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 relavant irritation or corrosion on rabbit eyes. 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 test substance (3-Sulfopropyl)-methacrylsäureester , K-Salz (SPM) was investigated for its potential to cause irritation in the rabbit eye according to OECD TG405. 0.1 g of pure substance were instilled into the conjunctival sac, the untreated eye served as control. Under the conditions of this experiment (3-Sulfopropyl)-methacrylsäureester , K-Salz (SPM) was found to cause no irritation when applied to the rabbit eye mucosa. No corrosion effect was observed at each of the measuring intervals. No discoloration of the cornea and conjunctivae which could be related to effects of the test material was observed. Additionally no corrosive or acute toxicological signs were observed in the animals during the test period. The primary irritation index was found to be for the unrinsed eye : 3.8. No classification according to Regulation (EC) 1272/2008 is required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance was found to be non irritating to both the skin and eye, as none of the scores (erythema, edema, corneal opacity, iritis, conjunctival redness, conjunctival oedema (chemosis)) as set out in Regulation 1272/2008 were found to be exceeded in the two available in vivo studies. Hence, no classification as irritant is triggered.