Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 405 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-hydroxyethanesulphonate
EC Number:
216-343-6
EC Name:
Sodium 2-hydroxyethanesulphonate
Cas Number:
1562-00-1
Molecular formula:
C2H6O4S.Na
IUPAC Name:
sodium 2-hydroxyethane-1-sulfonate
Details on test material:
- Name of test material (as cited in study report): Ethansalz 97/100
- Synonyms: Oxethansulfonsaures Natrium
- Substance type: solid
- Physical state: white powder
- Analytical purity: >= 97 %
- Lot/batch No.: Op. 36
- Production date: 21.05.1986
- Storage condition of test material: darkness at approx. 22 °C in a fume cupboard
- melting point: 160-180 °C
- pH in water : 11-11,5

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): undiluted product

No vehicle was used. Substance was applied as it is.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eyes were examined 1, 24, 48 and 72 hours after application of the test substance.
At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically All other changes or toxic effects were recorded.
Number of animals or in vitro replicates:
3
Details on study design:
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein-sodium solution took place, the treated eyes were washed out thoroughly with physiological saline at approx. 37 °C.


SCORING SYSTEM:

CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, 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
Opaque, iris invisible ..................................................................................................4

Affected area (Opactiy and fluorescein-test)
0 = no translucence
1 = punctiform up to 1/4
2 = more than 1/4 up to 1/2
3 = more than 1/2 up to 3/4
4 = more than 3/4 up t o 4/4

IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of 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


CONJUNCTIVAE

Redness (refers to palpebral and bulbar conjunctivae)
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3

Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h/ 48h / 72h
Score:
ca. 0.2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
ca. 0.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
ca. 0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
ca. 0.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Swelling of the lids and redness of the conjunctiva and iris was observed one hour after application. A clear discharge was also observed. These symptoms were reduced at 24 hours and dissappeared by 48 hours. The table below summarizes the symptoms observed.
The test substance is not considered irritating according to the criteria.

Any other information on results incl. tables

 Time post application        1 hour        24 hours        48 hours        72 hours
 Animal number  1  2  3  1  2  3  1  2  3  1  2  3
 Swelling  4  3  2  1  1  0  0  0  0  0  0  0
 Redness  1  1  2  2  1  1  1  0  1  0  0  0
 Iris  0  0  1  0  0  0  0  0  0  0  0  0
 Corneal Opacity  0  0  0  0  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 test substance is not considered irritating according to the criteria.
Executive summary:

Eye irritation was tested in a guideline study according to OECD guideline 405 in rabbits. The substance caused swelling of the lids and redness of the conjunctiva and iris one hour after application in the eyes. The mean score for three animals on day 1, 2 and 3 for chemosis and redness of the conjunctiva was 0.2 and 0.7, respectively. These symptoms were fully reversible by 48 hours.

The test substance is not considered irritating according to the criteria of this guideline.