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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed comparable to OECD 405, but without rinsing, little information on test material, Non GLP. Animals were not specific-pathogen free (non SPF)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
After the first hour, no rinsing was performed although colouring by the substance interfered with scoring. Directly after applications, eyelids were moved up and down for several seconds.
Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.42, 1973 (Draize test)

GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name of the test substance used in the study report: Scheckfarbstoff AS
The purity is stated as 100% of the drawn chemical structure in the order sheet. (Chemical structure is identical to the main component of the UVCB, CAS 6359-10-9)
The substance is stated to be a sales product.
The water solubility is indicated to be 20g/L. No information on pH is provided.
Specific details on test material used for the study:
solid
Scheckfarbstoff A.S.
Content: 100%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Mean body weight: 2.5 kg
The rabbits are kept in individual cages measuring 540 x 360 x 315 mm or in restraining devices. The animal house is ventilated (renewal of air = 12 times per hour; temperature 22°C; hygrometry 55 +/- 10%). The ear of each animal is pierced and a metal tag attached for individual identification.
200 g of food is provided per animal and day in the form of granules; water is given automatically and ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6
Details on study design:
Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out. The eye lids were held closed for several seconds and moved gently up and down to voiding loss of the substance .
Readings are made 1 hour, 24 hours, 2 days, 3 days, 4 days and 7 days after instillation. When irritation is persistent, readings are made each week over a maximum periodof 2 weeks. If the lesions are too important and prevent the ocular observations or if the intensity of the lesions increases after 7 days, the animals are sacrificed and the eye examined macrosopically.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.4
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Circumcorneal injection and congestion of the iris
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
3.34
Max. score:
4
Reversibility:
not fully reversible within: within 21 days
Remarks:
Fully reversible in four rabbits, almost reversed in one animal and strong chemosis in one animal.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Days 1, 2, and 3
Score:
35
Max. score:
110
Reversibility:
other: not applicable
Remarks on result:
other: Index of Ocular Irritation

Any other information on results incl. tables

1 Hour 24 Hours 48 Hours
Range Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6 Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6 Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6
A) Chemosis 0 - 4 2 3 2 2 3 2 3 3 3 3 4 4 3 4 4 2 4 4
B) Discharge 0 - 3 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
C) Redness 0 - 3 2 2 blue color 1 blue color 2 2 2 2 3 2 3 3 3 3 2 2 2
DIRECT PHOTOMOTOR REFLEX
OF PUPIL
  Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal (Permanent-myosis with preservation of direct photomotor reflex) Normal (Permanent-myosis with preservation of direct photomotor reflex) Normal Normal
Congestion of iris 0-2 1 (Cìrcumcorneal injection) 1 (Circumcorneal injection + congestion of the iris)
Opacity of cornea 0-4 3 3 3 2 3 2 2 2 2 2 2 2 3 3 2 2 2 2

72 Hours Day 4 Day 7
Range Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6 Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6 Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6
A) Chemosis 0 - 4 3 3 4 2 4 3 3 1 4 1 4 2 2 1 4 1 3 1
B) Discharge 0 - 3 2 1 2 2 3 2 1 0 2 0 1 0 0 0 1 0 2 0
C) Redness 0 - 3 3 2 3 2 2 2 1 1 3 1 3 1 1 1 2 1 2 1
DIRECT PHOTOMOTOR REFLEX
OF PUPIL
  Normal Normal (Permanent-myosis with preservation of direct photomotor reflex) Normal Normal Normal Normal (+myosis) Normal Normal (+myosis) Normal Normal Normal Normal (+myosis) Normal Normal (+myosis) Normal
Congestion of iris 0-2 1 (Circumcorneal injection + congestion of the iris) 1 (C.i.) 1 (C.i.) 1 (C.i.) 1 (C.i. + C.I.) 1 (C.i.) 1 (C.i. + C.I.) 1 (C.i.) 1 (C.i.) 1 (C.i.) 1 (C.i. + C.I.) 0 1 (C.i. + C.I.) 1 (C.i.)
Opacity of cornea 0-4 2 2 2 2 2 0 2 0 2 0 2 0 0 0 2 0 3 0

14 Days 21 Days
Range Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6 Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6
A) Chemosis 0 - 4 1 0 4 1 2 1 0 0 1 0 4 0
B) Discharge 0 - 3 0 0 1 0 2 0 0 0 0 0 2 0
C) Redness 0 - 3 0 0 1 0 1 1 0 0 0 0 2 0
DIRECT PHOTOMOTOR REFLEX
OF PUPIL
  Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal Normal
Congestion of iris 0-2 1 (C.i. + C.I.) 1 (C.i.) 1 (C.i.) 0 1 (C.i. + C.I.) 1 (C.i.) 1 (C.i.) 0 1 (C.i.) 0 1 (C.i. + C.I.) 0
Opacity of cornea 0-4 0 0 0 0 0* 0 0 0 0 0 0* 0

*Revascularization zone well defined on 1/4 of the corneal surface.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria