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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 20, 2006 to March 3, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD Guideline 405 and EU method B.5, 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-94633 Sulzfeld.
- Age at study initiation:
- Weight at study initiation:
Animal No. 121: 2.4 kg
Animal No. 122: 2.2 kg
Animal No. 123: 2.2 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 height.
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Analysis of the feed for ingredients and contmainants is performed randomly by Altromin, D-32791 Lage, Germany. Hay. briquettes (supplied by SSniff, D-59494 Soest) are offered additionally as a dietary supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: 19 days (animal No. 121) and 5 days (animals Nos. 122 and 123)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19 ºC (continous control and recording)
- Humidity (%): Average of 48.8% (continous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The weighed amounts of the individual doses were 53, 57 and 56 mg. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Both eyes of the animals were examined within 24 hours before instillation and approximately 1, 24, 48 and 72 h.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 72 hours
SCORING SYSTEM:
Grades for ocular lesions:
CORNEA
Opacity: degree of density (area most dense is taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (exept for slight dulling of normal lustre), details of iris clearly visible.
2 easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.
IRIS
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection; any of these or combination of any thereof, iris still reacting to light (lsuggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any of all these together)
CONJUNTIVAE
Redness: (refers to the most sever effect of parpebral and bulbar conjuntivae in comparison to the control eye)
0 Blood vessels normal.
1 Some blood vessels definitely hyperaemic (injected)
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes.
0 No swelling.
1 Any swelling above normal (includes nintating membranes)
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed.
TOOL USED TO ASSESS SCORE: otoscope lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24 -72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean 24 - 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 1 h: discharge, any amount different from normal.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: mean 24 - 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1h: discharge with moistening of the lids and hairs just adjacent to the lids; 24 h: discharge, any amount dofferent from normal.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean 24 - 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 1h: discharge, any amount different from normal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24 - 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The untreated eyes ("control eyes") were normal at each observation time.
The eyes, trated with the test susbtance ("test eyes") were normal before the instillation.
After the instillation with the test substance, the following findings were made:
Corneae: not affected.
Irises: not affected.
Conjuntivae, redness: a score of "1" in all animals from 1 h p.a. onwards until a maximum of 48 h p. a.
Conjuntivae, chemosis: a score of "2" or "1" in 2/3 animals only 1 h p.a., a score of "4" in 1/3 animals 1 h p.a., afterwards decreasing and lasting until 48 h p.a.
Additional findings: Ocular discharge was noted in all animals from 1 h p.a. until a maximum of 24 p.a. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results, the test substance is not an eye irritant.
- Executive summary:
Assessment of the possible irritating or corrosive effects of the pure test substance following a single administration into a conjunctival sac of rabbits was determinated according to OECD 405 Guideline and B.5 EU Method, with GLP. The approximate equivalent of 0.1 mL of the test substance was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits. No symtoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on the results, the test substance is not an eye irritant.
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