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EC number: 430-900-2 | CAS number: 192725-50-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 26 to Feb 18, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 84/449/EEC Part B Acute Toxicity
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study carried out in 1998
Test material
- Reference substance name:
- -
- EC Number:
- 430-900-2
- EC Name:
- -
- Cas Number:
- 192725-50-1
- Molecular formula:
- Hill formula: C9H16N2O3 CAS formula: C9H16N2O3
- IUPAC Name:
- 3-methyl-2-(2-oxo-1,3-diazinan-1-yl)butanoic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc, Portage, Michigan
- Age at study initiation: 2 - 3 weeks
- Weight at study initiation: 200 - 250gram
- Housing: Individual Stainless Steel ventilated cages
- Diet: Certified Guinea Pig Chow®
- Water: ad libitum
- Acclimation period: 5 days followed by an 7 day pretreatment period.
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72
- Humidity (%): Ambient
- Photoperiod (hrs dark / hrs light): 12hr daily light cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.2% HPMC for 1st induction: Petrolatum for 2nd induction and challenges.
- Concentration / amount:
- Concentration of test material at First Induction (Intradermal injection): 5% in 0.2% HPMC.
Concentration of test material at Second Induction (topical application): 55% in petrolatum
Concentration of test material used for challenge (topical applications): 55% in petrolatum
Challengeopen allclose all
- Route:
- other: Topically
- Vehicle:
- other: 0.2% HPMC for 1st induction: Petrolatum for 2nd induction and challenges.
- Concentration / amount:
- Concentration of test material at First Induction (Intradermal injection): 5% in 0.2% HPMC.
Concentration of test material at Second Induction (topical application): 55% in petrolatum
Concentration of test material used for challenge (topical applications): 55% in petrolatum
- No. of animals per dose:
- 10 animals assigned to the negative control group.
20 animals assigned to treatment group. - Details on study design:
- MAIN STUDY
An approximate 40 x 60mm area of dorsal skin on the scapular region was clipped free of hair prior to treatment
A. INDUCTION EXPOSURE
- No. of exposures: 2 - intadermal and topical
- Exposure period: 7 days for first induction and 14 days for second induction.
- Observations: 24hrs after the intradermal injections and once daily for 5 days. 24 and 48hrs after second induction.
- 0.05ml injection vol.
- Site for 2nd induction was pre-treared by massaging 0.3ml of 10% sodium dodecyl sulphate in water into the skin of animals in both groups on the day prior to topical inductionto illicit an inflammatory reaction.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 21
- Exposure period: 24hr occlusive bandage
- Site: right flank
- Evaluation (hrs after challenge):24 and 48 hr after challenge.
Body weights were measuredc twice during the pretreatment period, on the day of the first and second induction, on the day of the challenge and on the final day of the observations - Challenge controls:
- 10 animals with 0.2% Hydroxypropyl methylcellulose for the 1st induction, petrolatum for the 2nd induction. Challenge: 55% Abbott-164220 in petrolatum.
- Positive control substance(s):
- not required
- Remarks:
- Sensitivity tested periodically with α-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- n/a
In vivo (non-LLNA)
Results
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 55% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No signs of irritation
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 55% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: No signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Abbott-164220 did not induce delayed contact hypersensitivity in guinea pigs in this study. Criteria used for interpretation of results: EU
- Conclusions:
- Abbott-164220 did not induce delayed contact hypersensitivity in guinea pigs in this study.
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