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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-040-1 | CAS number: 114-07-8
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- July 12-29, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with GLP. Study material is well characterized. Protocol was si milar to OECD method of its time. Antibiotic toxicity observed at low concentrations- supporting study only.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- This study was conducted in accordance with Department 468 Standard Operating Procedure No.
0468-12-408. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Erythromycin
- EC Number:
- 204-040-1
- EC Name:
- Erythromycin
- Cas Number:
- 114-07-8
- Molecular formula:
- C37H67NO13
- IUPAC Name:
- 6-{[4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-[(5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy]-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (non-preferred name)
Constituent 1
Method
- Target gene:
- Salmonella typhimurium histidine auxotroph bacteria of the following strains were used for the nonac tivated and rat-liver-microsome-activated tests:TA-1535, TA-1537, TA-1538, TA-98 and TA-100
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium: TA1535, TA1537, TA98, TA100, TA1538
- Details on mammalian cell type (if applicable):
- The strains were received from Dr. Bruce Ames' laboratory, University of California, Berkeley, CA. Frozen cultures were prepared and stored at approximately -62°C. Flasks of nutrient broth were ino culated from the frozen cultures and grown overnight (approximately 18-20 hours) in a 37°C shaking water bath .
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix(2.5%) from Aclor 1254-induced rat liver
- Test concentrations with justification for top dose:
- The study was conducted at concentrations of 0, 0.4, 0.8, 1.6, 3.1, 6.3, 12.5, 25, 50 and 100 mcg per petri plate.
- Vehicle / solvent:
- solvent- Dimethyl sulfoxide
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle controls used in parallel with the test material
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: Quinacrine Mustard (QM) and 2-aminoanthracene
- Details on test system and experimental conditions:
- Petri plates of Vogel Bonner Medium E agar were prepared at least 24 hours in advance of their use in accordance with Department 468 Standard Operating Procedure No. 0468-11-403.Top agar was prepared according to Department 468 Standard Operating Procedure No .0468-11-404. Each 100 ml of top agar was supplemented with 10 ml of 0.5 mM L-histidine HCl and 0.5 mM biotin
For each petri plate, 0.1 ml of Salmonella broth culture, 0.05 ml of test compound solution and 0.5 ml of S-9 mix (activated tests only) were added to 2.0 ml of molten (approximately 45°C) top agar. The top agar mixture was poured over a hardened Vogel-Bonner medium E agar petri plate and a llowed to harden. Triplicate petri plates were prepared for all test combinations. The petri plates were incubated at approximately 37°C for approximately 48 hours - Statistics:
- Mean and standard deviation of the plate counts for each treatment were determined
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was seen at 25 mcg and higher in all strains except TA-98 and at 50 mcg and higher in TA-98
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ABBOTT-56268 showed no mutagenic effect on Salmonella as no increases in the number of colo nies on petri plates treated with test material was seen when compared to the number of colonies on vehicle control petri plates.Toxicity, as evidenced by a reduction in the number of bacterial colonies was seen at 100 and 50 mcg for all strains, at 25 mcg for all strains except TA-98 and at 12.5 mcg for TA-1535, TA-1538 and TA-100
- Remarks on result:
- other: all strains/cell types tested Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No dose-related and reproducible increases in revertant colony frequency were observed in any tester strains at any concentration, both with and without S9. The test substance was not genotoxic in the Ames test
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.