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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study with minor deficiencies concerning report details

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", by the Staff of the Division of Pharmacology, FDA
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Mercaptopropansulfonsaures Natrium (MPS)
- Name of test material: 1-Propanesulfonic acid, 3-mercapto-, monosodium salt
- Substance type: organic salt
- Physical state: white, finely crystalline powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.0 - 3.5 kg
- Housing: in individual cages
- Diet (e.g. ad libitum): standard diet (Altromin, Lage, Germany)
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ° C ± 2 ° C
- Humidity (%): 50 -60 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

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
- Concentration (if solution): pure / undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): none
Duration of treatment / exposure:
no data
Observation period (in vivo):
The reading of eye changes was performed after 1, 2, 4, 8, 24, 48, 72 and 96 hours and after 7 days.
Number of animals or in vitro replicates:
6
Details on study design:
Before and after the experiment, the eyes of all animals were examined with 0.15% fluorescein Thilo (R) for corneal changes. The animals were fasted 16 hours before initiation of the experiment. After determination of the animal weights, 0.1 g of the test substance was administered into the conjunctival sac of the left eye. The right eye served as control and remained untreated.

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

The total score for the eye is the sum of all points for cornea, iris and conjunctiva.
TOOL USED TO ASSESS SCORE: fluorescein
Before testing both eyes of each animal were examined. Any animal with eye defects were rejected.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 4, 8, 24 hours and 2, 3, 4, 5, 6, 7 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 4, 8, 24 hours and 2, 3, 4, 5, 6, 7 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 8 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 2 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 8 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 8 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 8, 24 hours and 2, 3, 4, 5, 6, 7 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
8 hours after application and later, no conjunctival irritation were noted. A very slight erythema was observed up to 4 hours after application and a very slightly increased secretion up to 1 hour after application.
Other effects:
no other effects reported

Any other information on results incl. tables

The verbal evaluation classes intended for the safety data sheet are:

Score

0 -10 = non irritant

11 - 25 = slightly irritant

26 - 56 = moderately irritant

57 - 110 = severely irritant

Table 1: single observations of eye irritation symptoms and summary of overall symptoms

single observations hours       days        
1 2 4 8 24 2 3 4 5 6 7
Animal-No. 1                      
1. Cornea A 0 0 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
2. Iris A 0 0 0 0 0 0 0 0 0 0 0
3. Conjunctiva A 1 1 1 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
C 1 0 0 0 0 0 0 0 0 0 0
Animal-No. 2
1. Cornea A 0 0 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
2. Iris A 0 0 0 0 0 0 0 0 0 0 0
3. Conjunctiva A 1 1 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
C 1 0 0 0 0 0 0 0 0 0 0
Animal-No. 3
1. Cornea A 0 0 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
2. Iris A 0 0 0 0 0 0 0 0 0 0 0
3. Conjunctiva A 1 1 1 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
C 1 0 0 0 0 0 0 0 0 0 0
Animal-No. 4                      
1. Cornea A 0 0 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
2.Iris A 0 0 0 0 0 0 0 0 0 0 0
3. Conjunctiva A 1 1 1 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
C 1 0 0 0 0 0 0 0 0 0 0
Animal-No. 5
1. Cornea A 0 0 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
2.Iris A 0 0 0 0 0 0 0 0 0 0 0
3.Conjunctiva A 1 1 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
C 1 0 0 0 0 0 0 0 0 0 0
Animal-No. 6
1. Cornea A 0 0 0 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
2.Iris A 0 0 0 0 0 0 0 0 0 0 0
3. Conjunctiva A 1 1 1 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0 0 0 0
C 1 0 0 0 0 0 0 0 0 0 0
summary hours       days        
Animal-No. 1 2 4 8 24 2 3 4 5 6 7
1 4 2 2 0 0 0 0 0 0 0 0
2 4 2 0 0 0 0 0 0 0 0 0
3 4 2 2 0 0 0 0 0 0 0 0
4 4 2 2 0 0 0 0 0 0 0 0
5 4 2 0 0 0 0 0 0 0 0 0
6 4 2 2 0 0 0 0 0 0 0 0
X 4.0 2.0 1.3 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was performed according to the OECD Guideline 405 without deviations and 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 rabbit eyes. The test material the test substance 1-Propanesulfonic acid, 3-mercapto-, monosodium salt (MPS) is classified as not irritant to the eyes.
Executive summary:

The test substance 1-Propanesulfonic acid, 3-mercapto-, monosodium salt (MPS) was investigated for its potential to cause irritation in the rabbit eye according to OECD TG405 (Dickhaus and Heisler, 1987). 0.1 g of pure substance were instilled into the conjunctival sac, the untreated eye served as control. Under the conditions of this experiment the test compound was found to cause no treatment-related findings like irritation or corrosion, when applied to the rabbit eye mucosa.