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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experiment start date: 04 February, 1980; Experiment end date: 12 February, 1980: Reported date: 26th February, 1980.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Disodium[4-{[5-chloro-2-(hydroxy-O)-3-nitrophenyl]diazenyl-N1}-3-methyl-1-phenyl-1H-pyrazol-5-olato(2-)-O][3-{[1-(3-chlorophenyl)-5-(hydroxy-O)-3-methyl-1H-pyrazol-4-yl]diazenyl-N1}-4-(hydroxy-kO)-5-nitrobenzenesulfonato(3-)]chromate(2-)
Cas Number:
72017-66-4
Molecular formula:
C32H19Na2Cl2CrN10O11S
IUPAC Name:
Disodium[4-{[5-chloro-2-(hydroxy-O)-3-nitrophenyl]diazenyl-N1}-3-methyl-1-phenyl-1H-pyrazol-5-olato(2-)-O][3-{[1-(3-chlorophenyl)-5-(hydroxy-O)-3-methyl-1H-pyrazol-4-yl]diazenyl-N1}-4-(hydroxy-kO)-5-nitrobenzenesulfonato(3-)]chromate(2-)
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test material: FAT 20202/B
Test material received: January 2, 1980
Additional identification: Physical appearance: powder

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: 2 to 3 kgs
- Housing: metal cages
- Diet: ad libitum access to standard rabbit food - NAFAG
- Water: ad libitum water
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2° C
- Humidity: 55 ± 10 %
- Photoperiod: 10 hour light cycle day

IN LIFE PHASE
Experiment start date: 04 February, 1980; Experiment end date: 12 February, 1980

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 g
Observation period (in vivo):
7 days
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
3 male and 3 female adult rabbits
Details on study design:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.

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:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20202/B is considered to be a non-irritant to the eyes.
Executive summary:

In a study performed to determine the eye irritation potential of FAT 20202/B, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1, 2, 3, 4 and 7 days. FAT 20202/B was found to cause a minimal irritation when applied to the rabbit eye mucosa. However, according to the Regulation (EC) No. 1272/2008 (CLP), FAT 20202/B is considered to be a non-irritant to the eyes.