Registration Dossier
Registration Dossier
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EC number: 296-117-1 | CAS number: 92257-28-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Evaluation of occular irritation produced by the test material introduced into the conjuntival sac of the rabbit eye.
- GLP compliance:
- no
- Remarks:
- pre-dates GLP regulation
Test material
- Reference substance name:
- 1,4-bis(p-tolylamino)anthraquinone
- EC Number:
- 204-909-5
- EC Name:
- 1,4-bis(p-tolylamino)anthraquinone
- Cas Number:
- 128-80-3
- Molecular formula:
- C28H22N2O2
- IUPAC Name:
- 1,4-Bis(p-tolylamino)anthraquinone
- Details on test material:
- - Name of test material (IUPAC name): 1,4-Bis(p-tolylamino)anthraquinone
- Common name: C.I. Solvent Green 3
- Molecular formula: C28H22N2O2
- Molecular weight: 418.4938 g/mol
- Smiles notation: c12c(c(Nc3ccc(cc3)C)ccc1Nc1ccc(cc1)C)C(=O)c1c(C2=O)cccc1
- InChl: 1S/C28H22N2O2/c1-17-7-11-19(12-8-17)29-23-15-16-24(30-20-13-9-18(2)10-14-20)26-25(23)27(31)21-5-3-4-6-22(21)28(26)32/h3-16,29-30H,1-2H3
- Substance type: Organic
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: KLEINTIERFARM MADOERIN AG; 4414 FUELLINSDORF / SWITZERLAND
- Age at study initiation: 12 weeks
- Weight at study initiation: 2,3 -3,0 kg
- Housing: The animals were caged individually in stainless steel cages.
- Identification: Individually by numbered ear tags and cage numbers.
- Diet (e.g. ad libitum): Pelleted standard KLIBA 341, rabbit maintenance diet,ad libitum.
- Water (e.g. ad libitum): Tap water,ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2 degC
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg/rabbit eye.
- Concentration (if solution): pure
VEHICLE
- none - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Duration of post- treatment incubation (in vitro):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (2m +1f)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were not washed.
SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Primary irritation index
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Unrinsed Eyes
- Irritant / corrosive response data:
- The test chemical showed no irritation when applied on the rabbit eye mucosa.
No discoloration of the cornea and conjunctivae was observed in the rabbits during the entire test period which could be related to compound effects.
No corrosion effect was observed at each of the measuring intervals. - Other effects:
- No acute toxicological signs were observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The test material showed no irritation when applied on the rabbit eye mucosa.
- Executive summary:
Under the conditions of this experiment the test material was observed to cause no irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae, which could be related to compound effects, was observed. The Primary Irritation Index was found to be: Unrinsed Eyes: 1.6. No corrosion effect was observed at each of the measuring intervals. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be an eye irritant.
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