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EC number: 807-752-6 | CAS number: 1451734-05-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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:
- 2000-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
Test material
- Reference substance name:
- 2,3-Dihydro-1,3-dioxo-1H-perylo[3,4-cd]pyridine-8,9-dicarboxylic acid potassim salt (1:2)
- EC Number:
- 807-752-6
- Cas Number:
- 1451734-05-6
- Molecular formula:
- C24H9NO6K2
- IUPAC Name:
- 2,3-Dihydro-1,3-dioxo-1H-perylo[3,4-cd]pyridine-8,9-dicarboxylic acid potassim salt (1:2)
- Details on test material:
- It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt.
Constituent 1
- Specific details on test material used for the study:
- It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt. However, based on the very similar properties of these compounds, the toxicological data presented is considered valid and suitable to describe the toxicological property of the di potassium salt even if generated with the mono salt.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, GER
- Age at study initiation: About 5 - 6 months
- Weight at study initiation: 3.37 - 3.79 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day).
- Water: Tap water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 18 mg of the comminuted test substance) - Duration of treatment / exposure:
- applied in a single dose, washed out after 24 hours
- Observation period (in vivo):
- 7 days
Readings: 1 h, 24 h, 48 h, 72 h and 7 d, 14d and 21 d after application - Number of animals or in vitro replicates:
- 2 males and 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
SCORING SYSTEM: according to OECD 405
in addition, conjunctival discharge was assessed as follows:
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye.
TOOL USED TO ASSESS SCORE: not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Cornea | Iris | Conjunctiva | Symptoms | |||||
Readings | Animal | Opacity | Area | redness | Swelling | Discharge | ||
1h | 1 | 0 | 0 | 0 | 2 | 2 | 1 | |
2 | 0 | 0 | 0 | 2 | 2 | 2 | ||
3 | 0 | 0 | 0 | 2 | 2 | 2 | ||
24 h | 1 | 1 | 4 | 1 | 3 | 2 | 0 | |
2 | 1 | 4 | 1 | 3 | 2 | 0 | 43 | |
3 | 0 | 0 | 0 | 3 | 2 | 1 | ||
48 h | 1 | 0 | 0 | 0 | 3 | 1 | 0 | |
2 | 1 | 4 | 0 | 3 | 2 | 1 | 43 | |
3 | 0 | 0 | 0 | 2 | 1 | 0 | ||
72 h | 1 | 0 | 0 | 0 | 2 | 1 | 0 | |
2 | 1 | 3 | 0 | 3 | 2 | 0 | LC, 43 | |
3 | 0 | 0 | 0 | 2 | 0 | 0 | ||
7 d | 1 | 0 | 0 | 0 | 0 | 0 | 0 | SD |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 44 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | SD | |
14 d | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 44 |
21 d | 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
mean | 1 | 0.3 | 0.3 | 2.7 | 1.3 | |||
2 | 1.0 | 0.3 | 3.0 | 2.0 | ||||
3 | 0.0 | 0.0 | 2.3 | 1.0 | ||||
mean | 0.4 | 0.2 | 2.7 | 1.4 |
LC: Loss of corneal tissue
SD: Study discontinued because the animal was free of symptoms
43: Parts of the conjunctiva and nictitating membrane brown discolored by rests of the test substance.
44: Part of the nictitating membrane brown discolored by a single, point-like rest of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the average conjunctival redness scores the substance is considered to be irritating to the eye of the rabbit.
- Executive summary:
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml bulk volume (about 18 mg) of the test substance. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 14. Moderate conjunctival redness, moderate swelling and slight to moderate discharge was observed in all animals on the day of application. However, severe conjunctival redness was noticed in all animals 1 day after application. 2 animals additionally showed moderate iritis and slight corneal opacity, whereas 1 animal also exhibited brown discolored parts of the conjunctiva and nictitating membrane by rests of the test substance. The ocular reactions were reversible in all animals within 7 days after application, the discoloration was reversible within 21 days. The average score (24 to 72 hours) for irritation was calculated to be 0.4 for corneal opacity, 0.2 for iris, 2.7 for conjunctival redness and 1.4 for chemosis. Considering the described ocular reactions as well as the average score for irritation, the test substance gives indication of an irritant property to the eye under the test conditions chosen.
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