Reaction mass of 3-[(2-aminoethyl)ammonio]propane-1-sulfonate and 3,3'-(ethane-1,2-diyldiammonio)dipropane-1-sulfonate and ethane-1,2-diamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-[(2-aminoethyl)amino]propane-1-sulfonic acid

Cas Number:

14235-54-2

Molecular formula:

C5H14N2O3S

IUPAC Name:

3-[(2-aminoethyl)amino]propane-1-sulfonic acid

Details on test material:

- Name of test material (as cited in study report): EPS
- Physical state: viscous
- Analytical purity: abt. 99 % (as specified by the sponsor)
- Lot/batch No.: LA 92018 SC
- Storage condition of test material: ambient

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm, 2740 Bremervörde, Neuendamm 88, Germany
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet: ad libitum, Ssniff K - Haltung
- Water: ad libitum, drinking water as for human consumption

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3° C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): artificial lightings (120 lux) from 7.00 a.m. - 7.00 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g / conjunctival sac of the left eye
- Concentration (if solution): undiluted

Observation period (in vivo):

1, 24, 48, 72 h after treatment

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
none

SCORING SYSTEM:
Cornea
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity.............................................................................................................................. 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre);
details of iris clearly visible ........................................................................................................................ 1
Easily discernible translucent area; details of iris slightly obscured ...................................................2
Nacrous area; no details of iris visible; size of pupil barely discernible .............................................3
Opaque cornea; iris not discernible through the opacity .....................................................................4
Maximum possible: 4
* The area of corneal opacity should be noted

Iris
Normal .........................................................................................................................................................0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia;
or injection; iris reactive to light (a sluggish reaction is considered to be an effect ......................1
Hemorrhage, gross destruction, or no reaction to light .....................................................................2
Maximum possible: 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Normal .........................................................................................................................................................0
Some blood vessels hyperaemic (injected) ............................................................................................1
Diffuse, crimson colour; individual vessels not easily discernible .....................................................2
Diffuse beefy red..........................................................................................................................................3
Maximum possible: 3
Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal .........................................................................................................................................................0
Some swelling above norma .....................................................................................................................1
Obvious swelling, with partial eversion of lids.......................................................................................2
Swelling, with lids about half closed ........................................................................................................3
Swelling, with lids more than half closed ................................................................................................4
Maximum possible: 4

TOOL USED TO ASSESS SCORE: visual examination

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 24 h

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EEC directive 84/449/EEC, September 19, 1984

Executive summary:

The potential toxicity of "EPS" was assessed in an acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1 g of the test article was introduced into the conjunctival say of the eye, the untreated eye serving as a control. Both eyes were examined at 1, 24, 48 and 72 h post application.

Clinical observation:

At 1 h p.a. conjunctival findings were apparent. Toxic effects other than ocular irritation were not observed.

Assessment:

The mean grades of ocular reactions at 24, 48 and 72 h p.a. were lower than the value classified as irritant by the EEC directive 83/467/EEC of July 29, 1983 and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBl. I, p. 2721). When applied to the eye, the test article "EPS" may therefore be considered to be non-irritant.