Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-11-25 - 1982-12-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report, which meets basic scientific principles

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)
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:
1-(3-sulphonatopropyl)pyridinium
EC Number:
239-491-3
EC Name:
1-(3-sulphonatopropyl)pyridinium
Cas Number:
15471-17-7
Molecular formula:
C8H11NO3S
IUPAC Name:
1-(2-hydroxy-3-sulphonatopropyl)pyridinium
Details on test material:
- Name of test material (as cited in study report): 1-(3-Sulfoproyl)-pyridinium-betain (PPS)
- Substance type: organic salt
- Physical state: white powder

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: approximately 14 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: caged individually in stainless steel cages, with automatic drinking water supply and cleaning system (Dipl. Ing. W. Ehret GmbH, Versuchstier Technik, 7830 Emmendingen, Germany).
- Diet (e.g. ad libitum): pelleted standard KLIBA 23/341/1, rabbit maintenance diet (Klingentalmuehle AG, 4303 Kaiseraugust /- Switzerland). Defined for acceptable contaminant level, ad libitum
- Water (e.g. ad libitum): tap water ad libitum (water quality according to the requirements of the "SCHWEIZ. LEBENSMITTELBUCH")
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

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 right eye served as untreated control
Amount / concentration applied:
0.1g
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 in total (2 males, 1 female) - the same animals were used for the skin and eye irritation experiment.
Details on study design:
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:
other: 24, 48 and 72 h
Score:
1.4
Max. score:
110
Reversibility:
other: not applicable
Remarks on result:
other: no irritation or corrosivity
Irritation parameter:
other: mean reaction score
Basis:
mean
Time point:
other: 1 hour
Score:
5.3
Reversibility:
fully reversible
Irritation parameter:
other: mean reaction score
Basis:
mean
Time point:
other: 24 hours
Score:
0.6
Reversibility:
fully reversible
Irritation parameter:
other: mean reaction score
Basis:
mean
Time point:
other: 48 hours and 72 hours
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: animal 1, 2 and 3
Time point:
other: 1 hour, 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: animal 1, 2 and 3
Time point:
other: 1 hour, 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
other: conjunctiva redness
Basis:
other: animal 1, 2 and 3
Time point:
other: 1 hour,
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: conjunctiva redness
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: conjunctiva redness
Basis:
other: animal 2 and 3
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
other: conjunctiva chemosis
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
other: conjunctiva chemosis
Basis:
other: animal 2 and 3
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
other: conjunctiva chemosis
Basis:
other: animal 1, 2 and 3
Time point:
other: 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
other: conjunctiva discharge
Basis:
other: animal 1 and 3
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
other: conjunctiva discharge
Basis:
animal #2
Time point:
other: 1 hour
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
other: conjunctiva discharge
Basis:
other: animal 1, 2 and 3
Time point:
other: 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
1 -(3 -sulfopropyl)-pyridinium-betain (PPS) 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.
Other effects:
no other effects reported

Any other information on results incl. tables

Table 1: Coloration index

Coloration index (mean of 3 animals)
males / females - not rinsed

Hours / days after application
1 hour 24 hours 48 hours 72 hours
Cornea 0 0 0 0
Conjunctivae 0 0 0 0
0 = none    
1 = slight  
2 = moderate
3 = severe

Table 2: eye irritation scores

Animal & sex Cornea  Iris Conjunctivae
Opacity Area inv.  Redness Chemosis Discharge
After 1 hour
101 M not rinsed 0 0 0 1 1

1
102 M not rinsed 0 0 0 1 0 2
103 F not rinsed 0 0 0 1 0 1
After 24 hours
101 M not rinsed 0 0 0 1 0 0
102 M not rinsed 0 0 0 0 0

0
103 F not rinsed 0 0 0 0 0 0
After 48 hours
101 M not rinsed 0 0 0 0 0 0
102 M not rinsed 0 0 0 0 0 0
103 F not rinsed 0 0 0 0 0 0
After 72 hours
101 M not rinsed 0 0 0 0 0 0
102 M not rinsed 0 0 0 0 0 0
103 F not rinsed 0 0 0 0 0 0

Table 3: mean reaction scores

Time period unrinsed eye
After 1 hour 5,3
After 24 hours 0,6
After 48 hours 0
after 72 hours 0

Table 4: primary eye irritation index

Selected observations

unrinsed eyes
After 1 hour

5.3
After 24 hours

0.6
After 48 hours

0.0
After 72 hours

0.0
primary irritation index

1.4
Assessment of irritation
0 to 10 = none
11 to 25 = slight
26 to 56 = moderate
57 to 110 = marked
Score according to ETAD, toxicological Methods 001-003 and VDI (Verband der chemischen Industrie), Sicherheitsdatenblatt

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
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 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 was considered to be not irritating under the conditions of the test.
Executive summary:

The test substance 1 -(3 -sulfopropyl)-pyridinium-betain (PPS) 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 1 -(3 -sulfopropyl)-pyridinium-betain (PPS) 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: 1.4.