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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 10, 2006 to January 17, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD Guideline 429 and EU method B.42, 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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: room temperature.
- Other:
pH: 6.16 (1% solution in deionised water, w/v, determined with a pH-Meter WTW pH340)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, D-33176 Borchen.
- Age at study initiation: About 8 weeks at the first administration.
- Weight at study initiation: 17.7 - 21.9 g.
- Housing: Group caging in Makrolon cages type IV (33 cm x 55 cm bottom area, 20 cm height). Wire meshes lids. Sanitation cages once a week..
- Diet (e.g. ad libitum): Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum (Producer: Altromin GmbH, D-32791 Lage) Random samples of feed are analysed for contaminants by Altromin.
- Water (e.g. ad libitum): Tap water offered in Makrolon bottles with stainless steel cannulae ad libitum.
- Acclimation period: 5 days; clipping of hair and washing with antibiotic solution was performed during acclimatisation.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.0 ºC (continous control and recording)
- Humidity (%): Average of 48.1 % (continous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
- air exchange: Approx. 12/h.
Study design: in vivo (LLNA)
- Vehicle:
- other: DMSO (w/w)
- Concentration:
- Group A (low dose): 5 % (w/w) solution of test substance in DMSO.
Group B (MID dose): 10 % (w/w) solution of test substance in DMSO.
Group C (high dose): 26.5 % (w/w) solution of test substance in DMSO.
Group P (positive control): 25% (v/v) solution of hexyl cinnamic aldehyde in acetone:olive oil (4:1, v/v)
Group K (negative control): DMSO - No. of animals per dose:
- 5 females.
- Details on study design:
- RANGE FINDING TESTS:
A range finding study was performed with two animals/concentration with following concentrations: 26.5 % and 10 % (26.5 % is the maximal achievable concentration that avoids overt systemic toxicity and excessive local irritation). Animals were treated with 25 µL test substance on the dorsum of each ear on 3 consecutive days. Ear thickness and body weight were measured on Day 1 before the first administration and on Day 4 about 24 hours after the last administration. In animals of both groups test substance remnants at the application sites were observed on Days 3 and 4, which is of no relevance for the results of a skin sensitisation study. None of the animals showed overt systemic toxicity, excessive local skin irritation at the application sites or an important increase in ear thickness in the range finding study. Therefore 26.5 % was chosen as highest test substance concentration and ear thickness measurement was not performed in the main study. As mid concentration 10 % was chosen, since 26.5 % is very near at the proposed 25%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: According to the guidelines the decission process with regard to a positive response includes a stimulation index of equal to or greater than 3, together with consideration of dose-response.
TREATMENT PREPARATION AND ADMINISTRATION: The test substance solutions were prepared freshly on each day of administration by the solution of test substance in DMSO (w/w) using an ultrasonic bath for the highest concentration. No analysis of test substance preparations were made. The test substance was solved in DMSO and was administered to 3 groups of 5 female. Administration was performed epicoutaneously to the dorsal surface of both ears, once a day, on 3 consecutive days. The volume applied was 25 µL. 5 days after the first topical administration, each animal received 20 µCi 3HTdR by slow intravenous administration. Approximately 5 hours after 3HTdR injection all animals were sacrificed and the draining auricular lymph nodes were rapidly excised. The lymph nodes of each group were pooled in PBS. A single cell suspension of lymph node cells was prepared by gentle mechanical disaggregation of the pooled lymph nodes through a 70 µm cell strainer. 3HTdR incorporation was determined with a β-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Application of 25 % HCA in AOO resulted in an SI of 3.5. This result proves the sensitivity of the strain of animals used anmd the reliability of the experimental technique.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Group A (low dose): 4.1 Group B (mid dose): 6.6 Group C (high dose): 7.9 Group P (positive control): 3.5 Group K (negative control): 1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Group A (low dose): 36177 dpm Group B (mid dose): 58470 dpm Group C (high dose): 69441 dpm Group P (positive control): 30431 dpm Group K (negative control): 8796 dpm
Any other information on results incl. tables
All animals survived till the end of the study.
No abnormal behaviour or clinical signs were detected during the experiment in the animals.
No local irritations were observed at the application sites of all animals of all test substance groups and both control groups throughout the whole study.
Body masses and body mass gains of all animals were in the range to be expected from animals of the same strain, sex and age. Body weight loss was noted in 2/5 animals in the high dose treatment group.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Stimulation Index of the tested test substance concentrations were 4.1 (low dose), 6.6 (mid dose) and 7.9 (high dose) (SIs > 3). According to the OECD Guideline 429 and the EU Method B.42, the test substance is regarded as a sensitizer in the LLNA.
- Executive summary:
The Local Lymph Node Assay was performed according to OECD Guideline 429 and the B.42 EU Method, to evaluate a possible sensitizing potential of the test substance. The test substance was solved in DMSO and was administered to three groups of 5 female CBA/Ca mice. Administration was performed epicutaneously to the dorsal surface of both ears, once a day on 3 consecutive days. The volume administered was 25 µL/ear. The concentrations used were: 5, 10 and 26.5 % w/w (solution of the test substance in DMSO). Two groups with 5 animals each served as positive and negative controls. Both control substances were administered under identical conditions as the test substances. The SIs of the tested test substance concentrations were 4.1 (low dose), 6.6 (mid dose) and 7.9 (high dose) (SIs > 3). According to the OECD Guideline 429 and the EU Method B.42, the test substance is regarded as a sensitizer in the LLNA.
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