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EC number: 690-920-4 | CAS number: 494799-38-1
- 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:
- 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- Cas Number:
- 494799-38-1
- Molecular formula:
- C16 H19 N O2
- IUPAC Name:
- methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CD 6003 XX
- Physical state: light yellow powder with chunks
- Storage condition of test material: room temperature, protected from light
- Analytical purity : 99.7 %
- Lot/batch No.: T1031
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Convance Research Products,Inc., Denver, Pennsylvania
- Age at study initiation: ca. 16 weeks
- Weight at study initiation: 2532 - 2543 g
- Housing: Individually housed in suspended stainless-steel racks
- Diet (e.g. ad libitum):Certified Hi-Fiber Rabbit Diet #5325 ; ca. 150 g of diet/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 - 70
- Air changes (per hr): minimum of 10
- Photoperiod (hrs dark / hrs light): 12 : 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0442 - 0.0446 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): saline
- Time after start of exposure: 24 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all animals
- Time point:
- other: 1,24,48,72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 2361
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 2362, 2363
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- other: 1,24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: all animals
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: all animals
- Time point:
- other: 1 h
- Score:
- 8.7
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, CD 6003 XX was minimally irritating and non-corrosive to the eyes of the rabbits under the conditions of the study.
- Executive summary:
This study assessed the relative level of ocular irritation/corrosion produced following a single dose exposure of CD 6003 XX to one eye each in three male albino rabbits.
On the day of dosing approximately 0.444 g of CD 6003 XX was placed into the everted lower lid of the right eye; the left served as the untreated control. The animals were evaluated for an obvious pain response ( e.g. vocalization and/or excessive pawing of the treated eye) upon instillation of the test article. Approximately 24 h after insitllation , the treated eyes were examined for residual test article; the residual ( if any ) test article was gently washed out using room-temperature physiological saline.
Eye irritation was evaluated and scored approximately 1, 24, 48 and 72 hours after instillation.
All rabbits survived to study termination. There were no test article-related changes in clinical observations or body weights.
There were no indication of pain in any animal upon instillation of the test article or shortly thereafter. At 1-hour postinstillation, test article was present in the treated eyes of all animals.Two animals were noted with findings in the iris.Findings in the conjunctivae including redness and chemosis in all animals , and discharge in two animals. At 24 hour postinstillation conjunctival redness was noted in all animals. At 48 hours postinstillation, all sings of irritation had resolved.
The maximum mean primary irritation score was 8.7 at 1 hour postinstillation. There was no evidence of corrosive or effects of the cornea in any treated eye.
CD 6003 XX was minimally irritating and non-corrosive to the eyes of the rabbits under the conditions of the study.
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