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EC number: 700-515-7 | CAS number: 1236007-63-8
- 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
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 study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Name "Isomaltulose Solution".
Trade name Isomaltulose Solution
Batch No. 03160483
Density 1.2 g/cm3 (20 °C)
Solubility in water unlimited.
Storage room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and strain: Rabbits, New Zealand White.
Supplier: Charles River Deutschland GmbH, D-88353 Kisslegg.
Number and sex: 3 females.
Body weight (at the start and at the termination of the study):
Animal No. 21: 2.2 kg and 2.3 kg.
Animal No. 22: 2.5 kg and 2.6 kg.
Animal No. 23: 2.4 kg and 2.5 kg.
Hygiene: Optimal hygienic conditions.
Room number: EI1-8.
Room temperature: Ranges from 19.29 to 21.42 °C.
Relative humidity: Ranges from 44.31 to 68.90 %.
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Individual caging in terulan cages, Ehret GmbH, A-3430 Tulln, 65 cm x 65 cm bottom area, 50 cm height.
Feed: Ssniff K-H maintenance diet for rabbits (item V-2333-000), ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany.
Water: Tap water from an automatic watering system, ad libitum.
Identification: Labelling with felt-tipped pen on a pinna and cage labels.
Acclimatisation: 7 days (animal No. 21) and 14 days (animal Nos. 22 and 23)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of the test substance was administered into the right eyes of each animal.
- Duration of treatment / exposure:
- The test substance was held closed for about 1 second to hold the test substance in the eye.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- 0.1 ml of the test substance was administered into the conjunctival sac of the right eye by gently pulling the lower lid away from the eyeball for instillation. The eye was held closed for about one second to prevent a loss of test substance. The left eye remained untreated and served as a control. The test substance was given to one animal. As no evidence for a serious damage to the eye of this animal was found during the initial 72 hour observation, the test substance was administered to the other two animals subsequently.
Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours p.a. No further examinations were performed thereafter. The scoring terms of 24, 48 and 72 h after the instillation were decisive for the interpretation of the results and the conclusion of the study. The whole eye, especially the cornea, the iris and the conjunctivae were examined, using an otoscope lamp. Eye irritation was scored and recorded using the scheme for eye lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All treated and untreated eyes appeared normal throughout the study.
- Other effects:
- None
Any other information on results incl. tables
|
Mean Scores for Animal No.: |
||
|
21 |
22 |
23 |
Cornea: |
0.0 |
0.0 |
0.0 |
Iris: |
0.0 |
0.0 |
0.0 |
Conjunctivae, redness: |
0.0 |
0.0 |
0.0 |
Conjunctivae, chemosis: |
0.0 |
0.0 |
0.0 |
Individual data
Examination of corneae, irises and conjunctivae. Individual data
and means.
|
|
|
Conjunctivae |
|||||||||
Time after |
Corneae |
Irises |
Redness |
Chemosis |
||||||||
|
21 |
22 |
23 |
21 |
22 |
23 |
21 |
22 |
23 |
21 |
22 |
23 |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
mean |
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:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No symptoms of systemic toxicity were observed in the animals at any time period. No mortality occurred.
- Executive summary:
The aim of this study was to investigate possible irritating or corrosive effects of the test substance following a single administration into the conjunctival sac of one eye of rabbits.
Methods
Methods and investigations were performed in accordance with the OECD-Guideline 405 and theCouncil Regulation (EC) No 440/2008,Method B.5.
Administration of the test substance
0.1 mL of"Isomaltulose Solution"was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits.Firstly the test substance was administered to one animal. As there was no corrosive or severe irritant effect observed, the test substance was administered to two additional animals one week later.
Investigations
· Body weights: at the start and at the termination of the test.
· General signs of toxicity: once daily.
· Eye examination: 1, 24, 48 and 72 h after the administration (p.a.) of the test substance.
Results
General signs
No other than ocular alterations were noted.
Eye examination
· Corneae and irises: Not affected at any observation point.
· Conjunctivae: Not affected at any observation point.
Conclusion
The following mean scores were calculated for each animal from the individual examinations performed 24 h, 48 h and 72 h p.a.:
Mean Scores for Animal No.:
21
22
23
Cornea:
0.0
0.0
0.0
Iris:
0.0
0.0
0.0
Conjunctivae, redness:
0.0
0.0
0.0
Conjunctivae, chemosis:
0.0
0.0
0.0
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