Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 608-211-5 | CAS number: 284462-37-9
- 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:
- September to November 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(4-aminophenoxy)-N-methylpyridine-2-carboxamide
- EC Number:
- 608-211-5
- Cas Number:
- 284462-37-9
- Molecular formula:
- C13 H13 N3 O2
- IUPAC Name:
- 4-(4-aminophenoxy)-N-methylpyridine-2-carboxamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.0-3.8 kg
- Housing: individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (J. Rettemnaier & Söhne, 73479 Ellwangen-Holzmühle, Germany). The wood granulate was changed at least twice weekly. The animals were regularly transferred to clean cages.
- Diet: ad libitum, standard diet “Ssniff K-Z” 4mm (manufacturer: Ssniff Spezialdiäten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day.
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the eye, which remained untreated, served as control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed) until 1 h after instillation, the eyes were rinsed with saline 1 h following instillation.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 1h after instillation with physiological saline
- Time after start of exposure: 1 h
SCORING SYSTEM: according to Draize et al.
TOOL USED TO ASSESS SCORE: fluorescein, 24 h after application, the eyes were treated with fluorescein and examined. If changes were observed additional fluorescein tests were performed on day 7, 14 and 21 until the changes observed had completely subsided, however for not more than 21 days after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- iris score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,3
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritant / corrosive response data:
- Redness of conjunctivae (grade 1) was observed in all animals 1 hour after instillation. The fluorescein test performed after 24 hours revealed no corneal effects.
- Other effects:
- No systemic intolerance reactions were observed.
Any other information on results incl. tables
Irritant effects on the eye |
| ||||||||||
Animal 1, Body Weight 3715 g |
|
|
|
|
|
|
| ||||
Observation | 1h | 24h | 48h | 72h | day 7 | day 14 | day 21 | ||||
Degree of cornea opacity | 0 | 0 | 0 | 0 | - | - | - | ||||
Area of cornea opacity | 0 | 0 | 0 | 0 | - | - | - | ||||
Fluorescein-degree | # | 0 | # | # | - | - | - | ||||
Coloration area | # | 0 | # | # | - | - | - | ||||
Iris | 0 | 0 | 0 | 0 | - | - | - | ||||
Redness conjunctivae | 1 | 1 | 0 | 0 | - | - | - | ||||
Chemosis conjunctivae | 0 | 0 | 0 | 0 | - | - | - | ||||
|
|
|
|
|
|
|
| ||||
Animal 2, Body Weight 3792 g |
|
|
|
|
|
|
| ||||
Observation | 1h | 24h | 48h | 72h | day 7 | day 14 | day 21 | ||||
Degree of cornea opacity | 0 | 0 | 0 | 0 | - | - | - | ||||
Area of cornea opacity | 0 | 0 | 0 | 0 | - | - | - | ||||
Fluorescein-degree | # | 0 | # | # | - | - | - | ||||
Coloration area | # | 0 | # | # | - | - | - | ||||
Iris | 0 | 0 | 0 | 0 | - | - | - | ||||
Redness conjunctivae | 1 | 0 | 0 | 0 | - | - | - | ||||
Chemosis conjunctivae | 0 | 0 | 0 | 0 | - | - | - | ||||
|
|
|
|
|
|
|
| ||||
Animal 3, Body Weight 2999 g |
|
|
|
|
|
|
| ||||
Observation | 1h | 24h | 48h | 72h | day 7 | day 14 | day 21 | ||||
Degree of cornea opacity | 0 | 0 | 0 | 0 | - | - | - | ||||
Area of cornea opacity | 0 | 0 | 0 | 0 | - | - | - | ||||
Fluorescein-degree | # | 0 | # | # | - | - | - | ||||
Coloration area | # | 0 | # | # | - | - | - | ||||
Iris | 0 | 0 | 0 | 0 | - | - | - | ||||
Redness conjunctivae | 1 | 1 | 0 | 0 | - | - | - | ||||
Chemosis conjunctivae | 0 | 0 | 0 | 0 | - | - | - | ||||
-: no further examination | |||||||||||
#: no examination | |||||||||||
Animal 1 | day 1-3: | Soft feces |
| ||||||||
Animal 2 | day 2 and 3: | soft feces | |||||||||
| day 1 and 2 | reduced food intake | |||||||||
| day 1 | reduced water intake | |||||||||
Animal 3 | day 2 and 3 | redcued food intake |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 female rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study Picolinamid-Phenylether shows very slight irritant effects (mean irritation index for conjunctivae score = 0.3 of max. 3) which were fully reversible within 2 days. No irritation effects were registered for cornea, iris and conjunctival chemosis up to 72 hours after instillation. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the eyes". No systemic intolerance reactions were observed.
- Executive summary:
In a primary eye irritation study similar to OECD TG 405, 0.1 mg of Picolinamid-phenylether was instilled into the conjunctival sac of one eye of 3 young adult female New Zealand White rabbits (3/sex) and the animals were observed for 21 days. The eyes were not washed until 1h after instillation, thereafter washing was performed with physiological saline. Irritation was scored by the method of Draize.
A single application of the test substance into the conjunctival sac provoked slight irritation of the conjunctiva in one animal which lasted up to 2 h after application. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters corneal opacity, iris score, chemosis score and conjunctivae score. In this study, the test item is not an eye irritant.
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.