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Diss Factsheets

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:
1978-11-02 to 1978-11-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
according to method from "Code of Federal Regulations", Title 16, Section 1500, 41
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
EC Number:
255-527-0
EC Name:
Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
Cas Number:
41741-86-0
Molecular formula:
C34 H24 Cr N8 O6 .Na
IUPAC Name:
Sodium;chromium(3+);2-[(3-methyl-5-oxido-1-phenylpyrazol-4-yl)diazenyl]benzoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: yes (about 2.5 kg)
- Housing: The rabbits are kept either in individual cages measuring 540 x 360 x 315 mm, or in restraining devices. The animal house is ventilated. The ear of each animal is pierced and a metal tag (Chevillot: La Quick) attached for individual identification.
- Diet (e.g. ad libitum): 200 g of food is provided per animal per day in the form of granules (Granulés Lapin "entretien" SANDERS).
- Water (e.g. ad libitum): Water is provided ad libitum and automatically.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55 ± 10
- Air changes (per hr): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
100 mg (amount deposited into the conjunctival sac of the eye)
Duration of treatment / exposure:
7 days (treatment without rinsing)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE:
- Washing: The test substance was not washed out.

DETAILS ON EVALUATION:
- Conjunctival lesions and discharge: An alteration of the palpebral conjunctiva is minor compared with corneal opacification or a lesion of the iris and pupil.
- Pupillary and iridial lesions:
Pupil: The dimension, form and position of the pupil is compared with the 1 control eye. The pupillary direct photomotor reflex (contraction of iris to reduce pupil-size) is observed by shining a bright light into the eye.

SCORING SYSTEM:
The anomalies found in the conjunctiva are scored according to the following scale:
- Chemosis (oedema)
No swelling = 0
Slight swelling (including nictitating membrane) = 1
Obvious swelling with partial eversion of lids = 2
Swelling with lids up to half closed = 3
Swelling with lids more than half closed = 4
- Discharge
Absence of discharge = 0
Discharge slight (does not include the small amount normally found in inner canthus) = 1
Discharge with moistening of lids and hairs adjacent to lids = 2
Discharge with moistening of lids and a considerable area around the eye = 3
(Note: The evaluation of discharge and swelling should be conducted before opening the lids of the animals.)
- Conjunctival enanthema (visible by pulling open the eye lids)
Vessels normal = 0
Vessels definitely congested above normal = 1
More diffuse, deeper crimson red, individual vessels not discernable = 2
Diffuse beefy red = 3
(Note: For the total score, the three values are added and multiplied by 2: (A+B+C) X 2 (maximum score: 20))

TOOL USED TO ASSESS SCORE: hand-slit lamp

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
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
No cornea opacity was observed in any of the tested animals. Slight findings regarding iris, chemosis and conjunctival redness resolved within two to three days.
Other effects:
The slight eye irritations were reversible within 2 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met