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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG

Test material

Constituent 1
Reference substance name:
Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
EC Number:
260-906-9
EC Name:
Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
Cas Number:
57693-14-8
Molecular formula:
C40H20CrN6O14S2.3Na

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean 2.76 kg (males), 2.87 kg (females)
- Housing: individually in cages made of stainless steel with wire mesh walk floors (floor area 40 cm x 51 cm)
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm (Muskator-Werke D-4000 Düsseldorf 1, FRG; about 130 g per animal per day)
- Water (e.g. ad libitum): tap water (about 250 ml per animal per day )
- Acclimation period: at least 8 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 90 mg) of the ground test substance
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 (2 females, 1 male)
Details on study design:
SCORING 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) Values
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)

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: mean, 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no readable effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Animal 1: female, 2.95 kg

Animal 2: female, 2.78 kg

Animal 3: male, 2.76 kg

Readings:

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge
1 h 1 0 0 0 0** 2 2 s
2 0 0 0* 0** 2 2 s
3 0 0 0* 0** 2 2 s
24 h 1 0 0 0 2 2 1  
2 0 0 0* 2 2 1 s
3 0 0 0* 2 2 1 s
48 h 4 0 0 0 1 1 0  
5 0 0 0 1 1 0  
6 0 0 0 1 1 0  
72 h 1 0 0 0 1 0 0  
2 0 0 0 1 1 0  
3 0 0 0 1 1 1  
8 d 1 0 0 0 0 0 0  
2 0 0 0 0 0 0  
3 0 0 0 0 0 0  
mean 24 - 72 h 1 0   0 1.3 1.0    
2 0 0 1.3 1.3  
3 0   0 1.3 1.3    
Mean 0   0 1.3 1.2    

s: irritation index could not be read because of staining due to the color of the test substance

*: if in 1 or 2 animals assessments referring to the same characteristic cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead

**: if in all animals assessments referring to the same CO characteristic cannot be made at a particular reading, zero is inserted instead

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008