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EC number: 607-864-3 | CAS number: 26116-57-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 24, 2006 to February 21, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD Guideline 402 and EU method B.3, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-10-(hydroxyimino)-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one hydrochloride
- Cas Number:
- 26116-57-4
- Molecular formula:
- C37H69ClN2O13
- IUPAC Name:
- (3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-10-(hydroxyimino)-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one hydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Erythromycin A-9 Oxime (E) Hydrochloride.
- Physical state: white powder.
- Lot/batch No.: B5310059
- Storage condition of test material: at ambient temperature, in the dark.
- Other:
pH: 6.16 (1% solution in deionised water, w/v, determined with a pH-Meter WTW pH340)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL: CD (SD) BR SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-94633 Sulzfeld.
- Age at study initiation: approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
- Weight at study initiation:
Animal No. 121: 275 g
Animal No. 122: 258 g
Animal No. 123: 265 g
Animal No. 124: 246 g
Animal No. 125. 258 g
Animal No. 126: 248 g
Animal No. 127: 239 g
Animal No. 128: 226 g
Animal No. 129: 230 g
Animal No. 130: 230 g
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids. Sanitation of cages once a week.
- Diet (e.g. ad libitum): Altromin 1324 forte (Producer: Altromin GmbH, D-32791 Lage) gamma irradiated with 25 kGy 60Co, ad libitum.
- Water (e.g. ad libitum): Tap water, offered in Makrolon bottles with stainless steel canules, ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 21.9 ºC (continous control and recording)
- Humidity (%): Average of 48.0 % (continous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
- Air change: 12 per hour.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6.5 cm x 8 cm
- % coverage: 10 % of the estimated body surface.
- Type of wrap if used: non irritating tape (Blenderm Wundpflaster, 3M)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off using wet cellulose tissue, if necessary.
- Time after start of exposure: 24 hours. - Duration of exposure:
- 24 hours.
- Doses:
- Range-finding study: 400, 894 or 2000 mg/kg bw.
Main study: limit-test with one dose of 2000 mg/kg bw. - No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Body weights: before administration, 7 and 14 days after administration.
Clinical observations: at least once per day (Observations: 0 - 0.5, > 0.5 - 1, > 1 - 2, > 2 - 4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for at least 2 weeks; observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions)
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- In a range-finding study 3 groups of one male and one female each were dosed with 400, 894 or 2000 mg/kg bw. All animals survived for 7 days p.a. Therefore a limit-test with one dose of 2000 mg/kg bw was performed.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No local or systemic effects related to administration of the test substance were noted from clinical observations. General findings: all animals were normal during the entire observation period. Observation of skin condition: exposed skin was not found t
- Other findings:
- - Other observations:
Staining of skin which is attributed to the staining properties of the test substance was observed in all animals.
Necropsy findings: all animals were normal at terminal necropsy.
Sex differences: No noteworthy sex difference in the response to the test substance was derived from clinical observations or post-mortem findings.
Any other information on results incl. tables
Table 1. Synopsis of the results.
Dose (mg/kg) |
Sex |
No. of animals |
Prominent findings |
||||
exposed |
affected |
deceased |
in life |
post mortem |
|||
systemic |
local |
||||||
2000 |
male |
5 |
0 |
0 |
none |
none |
none |
2000 |
female |
5 |
0 |
0 |
none |
none |
none |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No local or systemic test substance effects were noted at clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight. The dermal LD50 value of the test substance in rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
Assessment of acute dermal toxicity of the test substance was determined according to the OECD 402 Guideline and B.3 EU Method, with GLP. The test substance was administered once dermally on an area of approximately 6.5 cm x 8 cm on the dorsal thoracal region of 5 male and 5 female Sprague Dawley rats. The dose was 2000 mg/kg bw. A cellulose patch with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape. Patch and tape were covered semi-occlusively by a dressing. The duration of the exposure was 24 hours. The dermal LD50 value of the test substance in rats was established to exceed 2000 mg/kg bw.
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