Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
november 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
7 days post observation period only
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 88400 Biberach
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.3 - 3 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours per day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after application and at all other designated examination times at which the tr ated 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
Op&lescent areas, no details of iris visible, size of pupilbarely di scernib1e. . . . . . . .3
Opaque, iris invisible ...........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 coniunctivae)

Blood vessels nomal......... 0
Blood vessels definitely injected above normal............................ 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible..........................2
Diffuse beefy red............................3

Chemosis (refers to palpebral and bylbar conjunctivae)

no swelling..............0
Any swelling bove normal (includes nictitating membran).................. 1
Obvious swelling with partial eversion of lids............................ 2
Swell ing with lids about half closed...................................... 3
Swelling with lids half closed to completely closed....................... 4

Discharge

No discharge............................................................... 0
Any a.ount different from normal (does not include small amounts normally observed in inner canthus) ..........1
Discharge with moistening of the lids and hairs just adjacent to the lids...................2
Discharge with moistening of the lids and hairs, and considerable area around the eye........................................... 3

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 2d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One hour up to 24 hours after application of the test substance the conjunctiva of the animals showed definitely injected blood vessels and slight swellings. Additionally clear from substance coloured discharge was observed up to one hour after application. Two days after application all signs of irritationes were reversible.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met