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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 supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June 24, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
no
GLP compliance:
no
Remarks:
pre GLP

Test material

Constituent 1
Reference substance name:
Acid Blue 025:1
IUPAC Name:
Acid Blue 025:1
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.6 - 1.8 kg
- Housing: individually in metal cages (47x32x34 cm)
- Diet: ad libitum standard rabbit food - NAFAG Gossau SG
- Water : ad libitum
- Acclimation period: minimum 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1°C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs

HEALTH CHECK
- only rabbits with normal ophthalmic finding were used

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 minute exposure for 3 rabbits, 8 days exposure for 3 rabbits
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 rabbits (3 male and 3 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 rabbits 1 minute after treatment both eyes were rinsed with physiologic saline
- Time after start of exposure: The lids were held open for a few second

SCORING SYSTEM: according to AFDO guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Not irritant

Any other information on results incl. tables

time 1 h 6 h 1 d 2 d 3 d 6 d 8 d
sex m f f m m f m f f m m f m f f m m f m f f m m f m f f m m f m f f m m f m f f m m f
Animal n. 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61
eye, left/right n n n r r r n n n r r r n n n r r r n n n r r r n n n r r r n n n r r r n n n r r r
1. CORNEA                                          
A Opacity 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
B Area involved 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
a = AxBx5 (max 80) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
2. IRIS 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b = Score x 5 (max 10) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3. CONJUNCTIVAE                                          
A Redness 1 1 1 1 1 1 1 1 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
B Chemosis 1 1 2 0 1 1 1 1 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
C Discharge 1 1 1 0 1 0 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    c = (A+B+C)x2 (max 20) 6 6 8 2 6 4 6 6 4 2 6 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Total = a+b+c (max 110) 6 6 8 2 6 4 6 6 4 2 6 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Group Mean 6.7 4 5.3 4.7 0 0 0 0 0 0 0 0 0 0

According to the CLP Regulation, the mean scores for the substance to be registered, when applied to the eye of the animals, calculated following grading at 24, 48 and 72 hours after instillation of the test material, were 0 for corneal opacity, iritis, conjunctival redness and corneal opacity for all tested animals. 

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant
Executive summary:

The substance has been tested on rabbits according to the AFDO Guideline "Apparisal of Safety of chemicals in Foods, Drugs and Cosmetics" (1959). The test item has been inserted into the conjunctival sac of the left eye, the right one has been used as a control. In 3 rabbits both eyes were rinsed. A minimal transient conjunctival reaction was observed one hour after the application to the rabbit eye mucosa, this reaction was fully reversible within 24 hours. Rinsing the eyes following instillation was of practically no effect.