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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
The substance is applied in the eye of the rabbit undiluted. Observations are recorded 1 hour, 24 hours, 48 hours, 72 hours after application.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]chromate(3-), compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine
EC Number:
284-723-9
EC Name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]chromate(3-), compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine
Cas Number:
84962-27-6
Molecular formula:
C32H20CrN10O14S2.1.5(C28H31N2O3).1.5(C11H25NO)
IUPAC Name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]chromate(3-), compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine
Details on test material:
Name of the test substance used in the study report: Neozaponechtfeuerrot BL (96-3058)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: female 3.15 kg, male 3.65 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Cornea
(A) Opacity-degree of density (area most dense taken for reading)
0 = No opacity
1 = Scattered or diffuse area, details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Opalescent areas, no details of iris visible, size of pupil barely discernible
4 = Opaque, iris invisible

(B) Area of cornea involved
1 = One quarter (or less) but not zero
2 = Greater than one quarter, but less than half
3 = Greater than half, but less than three quarters
4 = Greater than three quarters, up to whole area

Iris
(A) Value s
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination af any thereof) iris still reacting to light (sluggish reactions is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)

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

(B) Chemesis
0 = No swelling
1 = Any swelling above normal (includes nictitatinq membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids about half closed to completely closed

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

TOOL USED TO ASSESS SCORE: fluorescein at day 8

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Conjunctival redness reappeared in the second animal and remained visible until the end of the observation period, which, however, was too short (8 days). All other findigs were minimal and reversible. Based on the overall minimal responses the test item is considered to be not irritating.

Any other information on results incl. tables

Results:

Readings Animal Cornea Iris Conjunctival Symptoms
Erythema  Chemosis
1h 1 0 0 1 1 0
  2 0 0 1 0 0
3 h 1 0 0 1 1 0
  2 0 0 1 2 0
24 h 1 0 0 1 0 0
  2 1 0 1 1 0
48 h 1 0 0 1 0 0
  2 0 0 1 0 0
72 h 1 0 0 0 0 0
  2 0 0 0 0 0
6 d 1 0 0 1 0 0
  2 0 0 0 0 0
8 d 1 0 0 1 0 0
  2 0 0 0 0 0
mean 24 -72 h 1 0.0 0.0 0.67 0.0  
 mean 24 -72 h 2 0.33 0.0 0.67 0.33  
mean 24 -72 h both 0.17 0.0 0.67 0.17  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met