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EC number: 231-493-2 | CAS number: 7585-39-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Compliant OECD Guideline study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cycloheptapentylose
- EC Number:
- 231-493-2
- EC Name:
- Cycloheptapentylose
- Cas Number:
- 7585-39-9
- Molecular formula:
- C42H70O35
- IUPAC Name:
- 5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2~3,6~.2~8,11~.2~13,16~.2~18,21~.2~23,26~.2~28,31~]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol (non-preferred name)
- Details on test material:
- BETA-CYCLOOEXTRIN (KLEPTOSE®)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino (no further details reported)
- Details on test animals or tissues and environmental conditions:
- Species: rabbit
Strain: albino
Origin: VASSEUR, PROUZEL. FRANCE
Sex: males
Weight: 2.0 kg - 3.0 kg
Number :6/group
Housing: individual stainless steel cage. wire-floor size 61 x 48 x 37 cm
Feed: SANDERS / LAPIPLUS - ROBENZ
Beverage: drinking water, automatic drinking bowl
Environment:
temperature 20° C +/- 1
hygrometry 50 %+/- 10
artificial lighting 12 hrs/day
air renewal 12 times/hr
The animals were housed for at least one week before the beginning of the experiment.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye served as control
- Amount / concentration applied:
- 0,1 ml of the substance
- Duration of treatment / exposure:
- The animals were placed in restraining devices (type IFFA CREDO les Oncins). The test substance was introduced into the conjonctival sac of the right eye of each rabbit. the left eye serving as a control; the instillation was unique. The eye was kept shut for one minute to avoid any loss of substance.
The animals were kept in the restraining devices for one hour, after which the
first reading was taken. - Observation period (in vivo):
- 1 hour, then 1, 2, 3, 4 and 7 days after the instilllation of the substance
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
According to the AFNOR NF T03-264 standard we determined:
- IIOI Individual Index of Ocular Irritation.
- MIOI Mean Index of Ocular Irritation
- IAOI The greatest Mean Index of Ocular Irritation (MIOI)
obtained from these readings is the Index of Acute Ocular Irritation.
IAOI MIOI (*) IIOl (*)
0 - 5 = 0 after 2 days non irritant
5 - 15 < 5 after 2 days slightly irritant
15 - 30 < 5 after 4 days irritant
30 - 60 < 20 after 7 days after 7 days very irritant
< 30 in 6 rabbits out of 6
and
< 15 in at least
4 rabbits out of 6
60- 80 < 40 after 7 days after 7 days severely irritant
< 60 in 6 rabbits out of 6
and
< 30 in at least
4 rabbits out of 6
80 - 110 extremely irritant
TOOL USED TO ASSESS SCORE: biomicroscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- given in tables
- Other effects:
- not reported
Any other information on results incl. tables
Reading Time |
Rabbit |
Conjunctiva |
IRIS |
Cornea Opacticity |
IIOI |
MIOI |
|
||||
|
|
Chemosis A |
Lachrynation B |
Enanthena C |
Reflex |
Congest ions D |
Degree E |
Surface F |
|
|
|
1 hr |
1 2 3 4 5 6 |
4 1 1 1 1 1 |
2 2 2 2 2 2 |
1 1 1 1 1 1 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
- - - - - - |
14 8 8 8 8 8 |
9.0 |
|
1 d |
1 2 3 4 5 6 |
1 0 1 0.5 1 1 |
0 0 0 0 0 0 |
1 1 1 1 1 1 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
- - - - - - |
4 2 4 3 4 4 |
3.5 |
|
2 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
- - - - - - |
0 0 0 0 0 0 |
0
|
|
3 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
- - - - - - |
0 0 0 0 0 0 |
0 |
|
4 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
- - - - - - |
0 0 0 0 0 0 |
0 |
|
7 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
- - - - - - |
0 0 0 0 0 0 |
0 |
|
x =2 (A + B + C)
y=5 x (D)
z= 5 x E x F
x+y+z = IIOI
Reading Time |
Rabbit |
Conjunctiva |
Iris
|
Cornea
|
|
|
|
Redness |
Swelling |
||
1 hr |
1 2 3 4 5 6 |
1 1 1 1 1 1 |
4 1 1 1 1 1 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
1 d |
1 2 3 4 5 6 |
1 1 1 1 1 1 |
1 0 1 0.5 1 1 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
2 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
3 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
4 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
7 d |
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is only slightly irritating to eyes when administered to rabbits.
- Executive summary:
In an eye irrtation assay with beta-Cyclodextrin (purity 100%) according to OECD Guideline 405 on 6 albino rabbits received 0.1 ml of the substance. The substance was administered to the conjonctival sac of the right eye of each rabbit. the left eye serving as a control; the instillation was unique. The substance was left in the sack and reading was performed after 1 h and 1, 2, 3, 4 and 7 days after administration. The scoring scheme used was that given by kay and Calanora. Only slight effects were seen in the conjunctiva score (especially chemosis, lachrynation and enanthena) which were fully reversible within 2 days. Under the conditions used beta Cyclodextrin can be clssified as only slightly irritant to the eyes of rabbits.
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