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EC number: 281-013-0 | CAS number: 83833-37-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 19 to May 03, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- 1993
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium
- EC Number:
- 281-013-0
- EC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium
- Cas Number:
- 83833-37-8
- Molecular formula:
- C36H24CrN9Na2O9S
- IUPAC Name:
- hydroxylamine
- 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
- Source: Dr. Karl Thomae GmbH, Postfach 1755, D-88397 Biberach a.d. Riss
- Age at study initiation: 14 weeks
- Weight at study initiation: male - 3.0 kg, females - 2.7 to 3.1 kg
- Identification: by unique cage number and corresponding ear tags.
- Housing: individually in stainless steel cages (size: 120 x 52 x 60 cm) equipped with
feed hoppers, drinking water bottles and wood for gnawing.
- Diet: Pelleted standard Kliba 341, Batch nos. 82/94 (at delivery of the animals to the
euthanasis of the animals) rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: community tap water from Füllinsdorf, ad libitum
- Acclimation period: four days under laboratory conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): between 40-76 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g of test item
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes not rinsed
SCORING SYSTEM: The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion (Commission Directive 93/21/EEC, April 27, 1993).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 25, 26, 27
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal: 25, 26, 27
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 25, 26, 27
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis
- Basis:
- animal: 25, 26, 27
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Remarks on result:
- other: Eyes not rinsed
Any other information on results incl. tables
VIABILITY / MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
COLORATION
In the area of application no staining of the cornea and conjunctivae by the test article was observed.
IRRITATION
The test item showed a primary irritation score of: 1.0, when applied to the conjunctival sac of the rabbit eye.
CORROSION
No corrosion of the cornea was observed at any of the reading times.
BODY WEIGHTS
The body weight of the animals was within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Non irritant
- Executive summary:
Method
The primary irritation potential of the test substance was investigated according to the OECD guideline 405.
0.1 g of the test item was istilled into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after substance application. Scoring of irritation effects were performed 1, 24, 48, 72 hours 7 and 14 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for -each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures.
Observations
No staining of the cornea and conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals.
Conclusion
Non irritant.
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