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EC number: 424-660-8 | CAS number: -
- 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:
- May 13 1996 to Jun 14 1996
- 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:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 92/69/EEC Part B
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study carried out in 1996
Test material
- Reference substance name:
- -
- EC Number:
- 424-660-8
- EC Name:
- -
- Cas Number:
- 224631-15-6
- Molecular formula:
- Hill formula: C18H26N4O5S CAS formula: C18H26N4O5S
- IUPAC Name:
- 2,5-dioxopyrrolidin-1-yl (2S)-3-methyl-2-{[methyl({[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl})carbamoyl]amino}butanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc, Michigan
- Age at study initiation: ~ 1 month
- Weight at study initiation: 200 - 220gram
- 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): 71 - 74
- 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: corn oil for 1st induction: Petrolatum for 2nd induction and challenges.
- Concentration / amount:
- Concentration of test material at First Induction (Intradermal injection): 5% in corn oil.
Concentration of test material at Second Induction (topical application): 50% in petrolatum
Concentration of test material used for challenge and rechallenge (topical applications): 50% in petrolatum
Challengeopen allclose all
- Route:
- other: Topically
- Vehicle:
- other: corn oil for 1st induction: Petrolatum for 2nd induction and challenges.
- Concentration / amount:
- Concentration of test material at First Induction (Intradermal injection): 5% in corn oil.
Concentration of test material at Second Induction (topical application): 50% in petrolatum
Concentration of test material used for challenge and rechallenge (topical applications): 50% 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
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: 2
- Day of first challenge: Day 21
- Day of rechallenge: Day 29
- Exposure period: 24hr occlusive bandage
- Test groups:
- Site: right flank - challenge; left flank - rechallenge
- Evaluation (hrs after challenge):24 and 48 hr after challenge and rechallenge.
Body weights were measured twice during the pretreatment period and on the days of the first and second inductions and the challenge and rechallenge and also on the final day of observations following the challenge and rechallenge treatments. - Challenge controls:
- 10 animals with corn oil for the 1st induction, petrolatum for the 2nd induction. Challenge and rechallenge: 50% Abbott-133816 in petrolatum.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- n/a
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 11
- Total no. in group:
- 17
- Clinical observations:
- slightly patchy erythema
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 11.0. Total no. in groups: 17.0. Clinical observations: slightly patchy erythema.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 1
- Total no. in group:
- 17
- Clinical observations:
- mild erythema
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 1.0. Total no. in groups: 17.0. Clinical observations: mild erythema.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 6
- Total no. in group:
- 17
- Clinical observations:
- slightly patchy erythema
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 6.0. Total no. in groups: 17.0. Clinical observations: slightly patchy erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 6
- Total no. in group:
- 17
- Clinical observations:
- slightly patchy erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 6.0. Total no. in groups: 17.0. Clinical observations: slightly patchy erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 6
- Total no. in group:
- 17
- Clinical observations:
- slightly patchy erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 6.0. Total no. in groups: 17.0. Clinical observations: slightly patchy erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 2
- Total no. in group:
- 17
- Clinical observations:
- mild erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 2.0. Total no. in groups: 17.0. Clinical observations: mild erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 2
- Total no. in group:
- 17
- Clinical observations:
- mild erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 2.0. Total no. in groups: 17.0. Clinical observations: mild erythema.
Applicant's summary and conclusion
- Interpretation of results:
- other: weak to mild allergenic potency in guinea pigs treated with Abbott-133816 in this study.
- Remarks:
- Criteria used for interpretation of results: other: Magnusson and Kligman
- Conclusions:
- Abbott-133816 exhibited weak to mild allergenic potency in guinea pigs in this study.
- Executive summary:
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
First Induction (Intradermal Injection): at injection sites
in animals that received corn oil, mild to moderate erythema
noted at 24 hours after first induction treatment and
slightly patchy to mild erythema after 48 hours. In animals
that received A-133816 in corn oil, mild to moderate
erythema was noted 24 hours after first induction and mild
to severe erythema after 48 hours, at the intradermal
injection site.
Second Induction (Topical Application): in animals
pretreated with sodium dodecyl sulphate on day prior to 2nd
induction, slightly patchy to mild erythema at the exposure
site was noted in animals exposed to petrolatum at 24 & 48
hours after patch removal, and in animals exposed to
A-133816 in petrolatum at 24 hours after patch removal.
Slightly patchy to mild erythema was also observed at the
exposure site in animals exposed to A-133816 in petrolatum
at 48 hours after patch removal. A single animal showed
moderate erythema at the exposure site at this time.
Evidence of sensitisation of each challenge concentration:
Initial Challenge with A-133816; after 24 hours:
Slightly patchy erythema noted in 11 animals;
Mild erythema noted in one animal.
After 48 hours: slightly patchy erythema observed in the
exposure site in 6 of the remaining animals.
Rechallenge; after 24 & 48 hours:
slightly patchy erythema noted at the test site in 6 of the
animals exposed to A-133816, and mild erythema in a further
2 animals (these responses in animals induced with
A-133816).
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