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Toxicological information

Eye irritation

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Administrative data

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

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 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

Test material

Constituent 1
Chemical structure
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 / tissue source

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.

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

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 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.