Registration Dossier
Registration Dossier
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EC number: 277-554-7 | CAS number: 73612-40-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 18th of January,1994 to the 25th of February, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test conducted according to internationally accepted testing guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- EC Number:
- 277-554-7
- EC Name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- Cas Number:
- 73612-40-5
- Molecular formula:
- C32H24Cl2CoN10NaO8S2
- IUPAC Name:
- sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
Age: 12-14 weeks old
Weight at study initiation: 2420 to 2560 g. The body weight was recorded at start and on day 3 of the test.
Housing: metal cages, individually numbered ear tags
Diet: rat food -NAFAG 814, Gossau SG, ad libitum
Water: ad libitum. The quality of the drinking water was according to the specification "Schweizerisches Lebensmittelbuch" (Edition 1972)
All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results available.
Acclimatization: 5 days
ENVIRONMENTAL CONDITIONS
Temperature: 20°C (+/- 3°)
Humidity: 30-70 %
Photoperiod (hrs dark / hrs light): 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 g
- Observation period (in vivo):
- The animals were checked daily for systemic symptoms and mortality.
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation. A slit-lamp was used to facilitate the evaluation. - Number of animals or in vitro replicates:
- 3 rabbits (1 male, 2 female)
- Details on study design:
- The substance was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lowel lid from the eyeball.
The lids were then held togethe for about one second in order to prevent the loss of the test article.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: chemosis
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: chemosis
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: chemosis
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- The eye reactions observed were reversible until the end of the observation period on day 3.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- non-irritant to albino rabbit's eye
- Executive summary:
The test was carried out according to the OECD 405 Guideline, in GLP.
The substance was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The right eye was used as control.
Under the experimental conditions employed the substance induced irritation of the cornea and conjunctiva when applied into the conjunctival sac of albino rabbits.
The mean values of the recordings from 24 to 72 hours after application are:
Cornea (mean 24, 48, 72 hours):
animal 1: 0
animal 2: 0
animal 3: 0
Iris (mean 24, 48, 72 hours):
animal 1: 0.0
animal 2: 0.0
animal 3: 0.0
Conjuntivae-redness (mean 24, 48, 72 hours):
animal 1: 0.33
animal 2: 0.33
animal 3: 0.33
Conjuntivae-chemosis (mean 24, 48, 72 hours):
animal 1: 0.0
animal 2: 0.0
animal 3: 0.0
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