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Diss Factsheets
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EC number: 627-354-4 | CAS number: 65873-72-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 September - 23 September, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 6-methoxypyridine-3-carbaldehyde
- Cas Number:
- 65873-72-5
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- 6-methoxypyridine-3-carbaldehyde
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch (Lot) Number: 2019-03-29
Physical Description: Cream powder
Storage Conditions: Kept in a controlled room temperature area, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Justification for Test System and number of animals:
The Sprague Dawley rat was chosen as the animal model for this study as it is an accepted rodent species for preclinical toxicity testing by regulatory agencies. A total of 13 male and 13 female Sprague Dawley rats were received on 03 Sept. 2019.
Six days were allowed between receipt of the animals and the start of treatment to accustom the animals to the laboratory environment. Each animal was uniquely identified using a subcutaneously implanted electronic identification chip.
Housing:
On arrival, animals were individually housed until randomization. Following, randomization, animals were socially housed in polycarbonate cages containing appropriate bedding equipped with an automatic watering valve.
Selection, Assignment, Replacement, and Disposition of Animals:
Prior to randomization procedures, the animals were weighed. Animals determined to be suitable as test subjects were assigned to groups by a stratified randomization scheme designed to achieve similar group mean body weights. Males and females were randomized separately.
Initial age: 8 weeks
Weight at the Initiation of Dosing: Males: 215 to 239 g.
Females: 152 to 181g.
Environmental Conditions:
The animal room environment and photoperiod were controlled (targeted conditions: temperature 20° C to 26°C, humidity 30% to 70%, 12 hours light and 12 hours dark, except during designated periods). The overall average temperature and relative humidity ranges during the study were 21°C to 22°C and 53% to 59%, respectively.
Food:
All animals had free access to a standard certified commercial laboratory diet.
Water:
Municipal tap water, purified by reverse osmosis and exposed to ultraviolet irradiation, was freely available, except during designated procedures.
Veterinary Care:
Veterinary care was available throughout the study; however, no veterinary examinations or medicinal treatments were administered during the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Reverse Osmosis Dionized (RODI) water
- Details on oral exposure:
- Administration of Test item:
On the day prior to dosing the animals chosen for use on the study were weighed and fasted. On Day 0, the test article was administered orally as a single dose (5, 50, 300, and 2000 mg/kg, 10 mL/kg) to rats (3/sex/group) using a syringe attached to a gavage cannula. Individual doses were calculated based on the animal's fasted (Day 0) body weight. Animals were returned to ad libitum feeding after dosing. - Doses:
- 5 mg/kg (group 1), 50 mg/kg (group 2), 300 mg/kg (group 3), 2,000 mg/kg (group 4)
- No. of animals per sex per dose:
- 3/sex/group
- Control animals:
- no
- Details on study design:
- In-life Procedures, Observations, and Measurements
Mortality/Moribundity Checks:
The animals were observed for general health/mortality and moribundity at least twice daily, at least once in the morning and at least once in the afternoon, throughout the study.
Clinical observations:
Each animal was removed from the cage and observed in detail a minimum of 2 times on Day 0 (postdose), with the first observation within approximately 30 minutes after dosing, and daily thereafter (Days 1 to 14).
Body Weights:
Individual body weights were recorded for all animals prior to fasting, prior to dosing (Day 0), and on Days 7 and 14.
Terminal Procedures:
No animals died as a result of this study. Animals surviving until scheduled euthanasia were weighed, euthanized by carbon dioxide inhalation, and discarded without examination. - Statistics:
- Body weight means and standard deviations were calculated separately for males and females for each limit level administered.
The LD50 was estimated as indicated below:
< 50% mortality: LD50 was estimated as greater than the administered dose.
= 50% mortality: LD50 was estimated as equal to administered dose.
> 50% mortality: LD50 was estimated as less than the administered dose.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study. All animals survived to scheduled euthanasia on Day 14.
- Clinical signs:
- other: Test article-related clinical observations included hunched posture in animals administered 2000 mg/kg and erected fur in animals administered ≥300 mg/kg. All clinical signs resolved by Day 7. Group 3 – 300 mg/kg Test article-related clinical observatio
- Gross pathology:
- Not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the median lethal dose (oral LD50 value) of COM-1074 (Intermediate 2607535) in Sprague-Dawley rats was estimated to be greater than 2000 mg/kg/bw. Therefore, the GHS criteria was not met.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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