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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: experimental data on similar substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
EC Number:
289-068-2
EC Name:
Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
Cas Number:
85959-73-5
Molecular formula:
C32H22CoN8O16S2.3Na
IUPAC Name:
trisodium;cobalt(3+);(2Z)-2-[(5-nitro-2-oxido-3-sulfonatophenyl)hydrazinylidene]-3-oxo-N-phenylbutanimidate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age: 15-16 weeks
Body weight: 2.4 -2.8 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 4 days under test conditions after veterinary control.
Accomodation: Caged singly in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG D
Air conditioned with 10-15 air chnages per hour and hourly monitored environment with temperature of 22°C and with a humidity of 40-70%.
Animals were exposed to artificial light for 12 hours daily, Music/light period.
Diet: Pelleted standard Kliba 341, Batch 11/85 rabbit maintenance diet (Kliba, Klingentalmuehle AG, Kaiseraugst CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water from Itingen ad libitum. The water was analysed and the results are attached to the study report.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye serves as control
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
no data
Observation period (in vivo):
up to 14 days
Number of animals or in vitro replicates:
2 males / 1 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
male and female
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
male
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 66
Remarks:
female
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal: 64
Remarks:
male
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal: 65
Remarks:
male
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal: 66
Remarks:
female
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible
Irritant / corrosive response data:
No corrosion of cornea was observed at any of the measuring intervals.
Other effects:
Coloration: in the area of application a clear visible brownish disocloration of the cornea and conjunctivae was observed which could be related to the color of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The tested substance needs to be considered irritant for rabbits eyes under Regulation CE 1272/2008.
Executive summary:

The ocular reactions were determined followign OECD 405.

The tested substance is considered to be irritant for the rabbits eyes based on the results needs to be classified as H319, Causes serious eye irritation under Regulation 1272/2008.