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EC number: 240-886-8 | CAS number: 16867-03-1
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.06. - 06.07.1993
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-aminopyridin-3-ol
- EC Number:
- 240-886-8
- EC Name:
- 2-aminopyridin-3-ol
- Cas Number:
- 16867-03-1
- Molecular formula:
- C5H6N2O
- IUPAC Name:
- 2-aminopyridin-3-ol
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Number of animals: 55 males, 55 females.
Age: approx. 10 weeks (females), older than 12 weeks (males).
Acclimatisation period: 11 days.
Animal identification: tattoo in the right pinna (females), labeling on the tail with felt tip pen (males).
Conditions:
Room temperature: approx. 22 °C
Relative humidity: approx. 55 %
Air exchange: 12 / h.
Light: artificial light from 6 a.m. to 6 p.m.
Bedding material: Aspen woord chips
Food: Ad libitum
Water: Ad libitum, deionisied water
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Duration of treatment / exposure:
- day 6 throughout day 15 of gestation, dose volume: 10 mL/kg bw
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- vehicle control, group K
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Remarks:
- group A
- Dose / conc.:
- 45 mg/kg bw/day (nominal)
- Remarks:
- group B
- Dose / conc.:
- 135 mg/kg bw/day (nominal)
- Remarks:
- group C; Dosage was 135 mg/kg body weight in the beginning of the
study and was lowered to 90 mg/kg body weight after 5 days dosing as mortality occurred.
- No. of animals per sex per dose:
- 25 (females)
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 45 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- changes in number of pregnant
- changes in pregnancy duration
- clinical biochemistry
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: neoplastic
- maternal abnormalities
- mortality
- necropsy findings
- number of abortions
- ophthalmological examination
- organ weights and organ / body weight ratios
- pre and post implantation loss
- total litter losses by resorption
- urinalysis
- water consumption and compound intake
Results (fetuses)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 45 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
- external malformations
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 90 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- It is concluded that none of the effects observed indicate a direct embryotoxic or teratogenic induction to the foetus.
The "no adverse effect level" is 45 mg "A-132"/kg
body weight for the dams and foetuses. - Executive summary:
This study was performed to·reveal possible maternal, embryotoxic and/or Leratogenic effects of the test substance after oral administration.
A toxic effect of the test substance to the dams of the highest dosed group, expressed by mortality and statistically significant decreased body weight gain with corresponding decreased food consumption at the beginning of the dosing period was noted
At skeletal examination of the foetuses statistically significant more foetuses with rudimentary lumbar ribs and variations in general were observed in the highest dose group and this was considered tobe due to maternal toxicity.
The occurrence of statistically significant more foetuses with uncompletely ossified caudal vertebrae of animals of group B and of statistically significant more foetuses with uncompletely ossified pelvis of animals of groups A and B is considered of no relevance as it is not dose dependent.
At visceral examination the occurrence of significant more foetuses with slightly enlarged brain ventricles of groups A and B was also considered of no relevance as it was not dose dependent.
Therefore it is concluded that none of the effects observed indicate a direct embryotoxic or teratogenic induction to the foetus.
The "no adverse effect level" is 45 mg "A-132"/kg body weight for the dams and foetuses.
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