Registration Dossier
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EC number: 221-424-4 | CAS number: 3089-17-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Flash point
- Auto flammability
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- Oxidation reduction potential
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- Additional physico-chemical information
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- Endpoint summary
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 JUL 1992 to 31 JUL 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-TSCA 40 CFR 798
- Deviations:
- no
- Principles of method if other than guideline:
- - test for acute irritation of the eye in rabbits (0.1 mL of the test item was instilled into the conjunctival sac of one eye of each rabbit (6 animals in total). The eyes remained unwashed. Ocular responses were assessed at 1 hour post dose and on days 1, 2 and 3.)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
- EC Number:
- 221-424-4
- EC Name:
- 2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Cas Number:
- 3089-17-6
- Molecular formula:
- C20H10Cl2N2O2
- IUPAC Name:
- 2,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- 3 male /3 female animals tested
- Source: Ace animals
- Weight at study initiation: 2.4 to 2.9 kg
- Housing: 1/ cage in suspended
- Diet: Fresh purina rabbit chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12 /12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 72 h (eyes remained unwashed)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6 (3 males/3 females)
- Details on study design:
- SCORING SYSTEM: basically in accordance to OECD TG 405
- evaluation was performed 1, 24, 48, and 72 hours after application of the test item
TOOL USED TO ASSESS SCORE: The eyes of all rabbits were examined with sodium fluorescein after the 24 hour reading.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1/#2/#3/#4/#6
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: redness
- Irritant / corrosive response data:
- - there were no corneal or iridial effects, as well as no chemosis visible at any time
- in 1/6 animals there was a conjunctival effect visible (score (redness):1) at the 24 hour reading. At any other time as well as in the remaining animals no conjunctival effects were observed. - Other effects:
- For up to one hour after the instillation of the test item into one eye it remained in the conjunctiva in all animals as well as the area around the eyes were stained magenta for the whole duration of the test.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material 2, 9-Dichloroquinacridone is not irritating to eyes under these test conditions. Test material 2, 9-Dichloroquinacridone contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
- Executive summary:
Test material 2, 9-Dichloroquinacridone was subject to an acute eye irritation/corrosion test in 6 New Zealand white rabbits according to FDA guideline. The test item (0.1 mL) was instilled into the conjunctival sac of one eye of each rabbit and the eyes remained unwashed. Ocular responses were assessed at 1 hour post dose and on days 1, 2 and 3. Under these conditions no corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 1/6 animals at 24 hours after instillation of the test item (score (redness): 1). This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material 2, 9 -Dichloroquinacridone is not irritating to eyes and has not to be classified for eye irritation.
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