Registration Dossier
Registration Dossier
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EC number: 204-909-5 | CAS number: 128-80-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 chemical 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[(4-methylphenyl)amino]-9,10-anthraquinone
- Test material form:
- solid
- 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
- Physical State: Solid
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, concurrent no treatment
- 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
- Number of animals or in vitro replicates:
- 3 (2 male and 1 female)
- 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 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.
Hence, the test chemical was considered to be not irritating to eyes. - Executive summary:
An ocular irritation study of test chemical was conducted on New Zealand White rabbits according to OECD guideline 405.
About 100mg of undiluted chemical was instilled into the one eye of each rabbit whereas the other untreated eye served as control.
The treated eyes were not rinsed and the ocular lesions were scored after 72 hours according to Draize method.
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.
Hence, the test chemical was considered to be not irritating to eyes.
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