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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Relatively well reported study according to guideline/standard.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test compound: PDTN
Appearance: white crystalline solid
Chemical name: Acetonitrile,2,2',2'',2'''-(1,3-propanediyldinitrilo)tetrakis-
Batch no: JNN98038
Composition: PDTN 99.2±1.0% m/m; water 0.5±0.1% m/m
Storage: at room temperature in the dark
Expiry date: 1 June 2000

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 7 weeks
- Weight at study initiation: 1313-1461 g
- Housing: individually in cages with perforated floor
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (no exact data reported)
- Humidity (%): 50 (no exact data reported)
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 15 To: 18 June 2008

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 66.4±0.1 mg (corresponding to a volume of ca. 0.1 ml
- Concentration (if solution): not applicable
Duration of treatment / exposure:
single application
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no info

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
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible 4

IRIS
Normal 0
Folds above normal, congestion, swelling, circumcorneal 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

CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, indiviual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Immediately aftre the 24-h observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of
each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was
estimated as a percentage of the total corneal area.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable as there were no corneal reactions
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
Iridic irritation (grade 1) was observed in 2 animals, 1 h after instillation only. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 24 h in one animal and within 48 h in the other 2 animals
Other effects:
No symptoms of systemic toxicity were noted.

Any other information on results incl. tables

Summary of ocular reactions

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean

score

iritis

Days

1/2/3

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

3

7

21

1069

M

Cornea

Iris

Redness

Chemosis

0

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

0

0

0

0

1071

M

Cornea

Iris

Redness

Chemosis

0

0

1

2

0

0

1

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

0

0

0.33

0

1073

M

Cornea

Iris

Redness

Chemosis

0

1

2

2

0

0

2

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

0

0

0.67

0

Mean all anim.

0

0

0.33

0


Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material was slightly irritating to the rabbit eye but all ocular changes had disappeared within 48 h. No classification was, however, needed, according to OECD-GHS.
Executive summary:

A study was performed to assess the irritancy potential of the test material, PDTN, to the eye of the New Zealand White rabbit. The method used

followed that described in the OECD 405 and Method B5 in Commission Directive 92/69/EEC. A single application of the test material to the eye of

three rabbits produced minimal iridic and conjunctival irritation. All treated eyes appeared normal 48 hours after treatment. The test material does not

require classification according to OECD-GHS.