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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 249-227-9 | CAS number: 28797-48-0
- 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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- 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:
- old study
Test material
- Reference substance name:
- 11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
- EC Number:
- 249-227-9
- EC Name:
- 11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
- Cas Number:
- 28797-48-0
- Molecular formula:
- C14H10ClN3O2
- IUPAC Name:
- 11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Charles River , Germany- Age at study initiation: approx. 7 weeks- Weight at study initiation: 421.1 - 508.5 g- Housing: Animals were housed individually in Norly cages, type IV - Diet (e.g. ad libitum): Dry food in pellet form was supplied ad libitum - Water (e.g. ad libitum): Municipal drinking water was available at any time via drinking bottlesENVIRONMENTAL CONDITIONS- Temperature (°C): 17 - 23- Humidity (%): 45 - 75- Air changes (per hr): maximum 12- Photoperiod (hrs dark / hrs light): 12 : 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: ethanol
- Concentration / amount:
- 1) 1 % suspension of L-S 519 / Chloracetyl in ethanol abs2) 2% suspension of L-S 519 / Chloracetyl in ethanol abs. and Freund'sComplete3) Freund's Complete Adjuvant with 0.9% NaCl solution
- Day(s)/duration:
- day 1 / injection
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25% suspension of L-S 519 / Chloracetyl
- Day(s)/duration:
- day 8 - 10 / 48 h
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25% suspension of L-S 519 / Chloracetyl
- Day(s)/duration:
- day 22 / 24 h
- No. of animals per dose:
- 20 animals per test group10 animals per control group
- Challenge controls:
- 10 female animals , 0.3 mL test item + ethanol
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: category 1A according CLP
- Conclusions:
- In the sensitisation test based on Magnusson and Klingman`s " Guinea Pig Maximisation Test" , L-S 519/Chloracetyl did induce allergic reactions by skin contact in 19 of the 20 guinea pigs treated. Thus, L-S 519/Chloracetyl revealed a sensitising potential under the stated study conditions.
- Executive summary:
Objective:
The aim of the present study was to assess the allergic potential of L-S 519 / Chloracetyl following intradermal and topical occlusiv administration in guinea pig.
Design of Study :
A skin sensitisation study with L-S 519/Chloracetyl was carried out in guinea pig according to the " Guinea Pig Maximisation Test", using 2 groups of animals : a negative control group ( 10 females ) and a L-S 519 / Chloracetyl treated group ( 20 females) . The control group was treated during the sensitisation phase in an identical manner as the test group with the solvents used.
The animals of the L-S 519 / Chloracetyl group were treated as follows :
Day 1 : 3 pairs of intradermal injections with
a) 1% suspension of L-S 519 / Chloracetyl in ethanol abs.
b) 2% suspension of L-S 519 / Chloracetyl in ethanol abs. and Freund`s Complete Adjuvant ( ratio 1:1)
c) Freund`s Complete Adjuvant with 0.9% NaCl solution (1:1)
Day 8 to 10 : topical occlusiv application of a 25% suspension of L-S 519 / Chloracetyl in ethanol abs. to the same area of the skin
Day 22 : challenge of an allergic contact dermatitis by 24 hour topical occlusive application of a 25% suspension of L-S 519 /
Chloracetyl in ethanol abs.
The skin reaction were evaluated 24 and 48 hours after removal of the occlusive system.
Main results :
After the occlusive treatment on 22nd day of the study, no skin reactions were observed in the animals of the control group. In the L-S 519 / Chloracetyl treated group , 24 hours after removal of the occlusive system 19 animals showed moderate reddening of the whole area of application or severe reddening and swelling . 48 h after removal of the occlusive system, still 13 animals showed moderate reddening of the whole area of application or severe reddening and swelling.
Conclusion :
In the sensitisation test based on Magnusson and Klingman`s " Guinea Pig Maximisation Test" , L-S 519/Chloracetyl did induce allergic reactions by skin contact in 19 of the 20 guinea pigs treated. Thus, L-S 519/Chloracetyl revealed a sensitising potential under the stated study conditions.
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.