Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according OECD guideline-

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
name: Cyanamide, (4,5-dihydroxy-2-thiazolyl)-
molecular formula: C4 H5 N3 S
molecular weight: 127.2
physical state: solid
analytical purity: 98 %

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CHR. FRED LEUSCHNER & CO., D-24601 Lohndorf/Post Wankendorf
- Age at study initiation: approx. 5 months
- Weight at study initiation: 2.1 - 2.6 kg
- Housing: For 8 hours following test substance application, the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn. During the acclimatisation period and after the 8-hour period in restrainers, the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 m (manufacturer: Dipl. Ing. W. EHRET GmbH, D-1 6352 Schonwalde)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 50% ± 20%
- Photoperiod (hrs dark / hrs light): The rooms were alternately lit (1 50 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Observation period (in vivo):
Observations at 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 male
Details on study design:
SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of
normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly
obscured
3 nacreous areas, no details of iris visible, size of pupil barely
discernible
4 Opaque cornea, iris not discernible through the opacity
IRIS
0 normal
1 markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia, or injection, any of these or combination
of any thereof, iris still reacting to light (sluggish reaction
is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all
of these)
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
0 blood vessels normal
1 some blood vessels definitely hyperaemic (injected)
2 diffuse, crimson colour, individual vessels not easily discernible
3 diffuse beefy red
Chemosis: lids and/or nictitating membrane
0 no swelling
1 any swelling above normal (including nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed
Any further lesions are listed.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: all readings
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: all readings
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all reading
Score:
0.22
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all readings
Score:
0.22
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The fluorescein test performed after 24 hours revealed corneal staining in one animal 24 hours up to 48 hours after instillation (1/4 of the surface).
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the findings in this study the substance is not subject to classification.
Executive summary:

Under the present test conditions a single application of 100 mg 2-Cyanimino-1,3-

thiazolidin per animal into the conjunctival sac of the right eye of three rabbits caused

the following effects:

Corneal opacity (grade 1) was observed in one animal 24 hours up to 48 hours after

instillation.

One rabbit showed an irritation of the iris (grade 1) at the examination time-point 24

hours after instillation up to 48 hours.

The fluorescein test performed after 24 hours revealed corneal staining in one animal

24 hours up to 48 hours after instillation (1/4 of the surface).

The conjunctivae were not affected.

There were no systemic intolerance reactions.