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EC number: 701-248-9 | CAS number: -
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Annex XI of Regulation 1907/2006 and the REACH Guidance (R 6.2) permits the grouping of chemicals (chemicals categorisation). Barratt and Illing (2007, revised 2009a; 2009b, see attachments in section 13 of IUCLID data set) set out justification for an initial grouping of the polyols (oligomers and polymers) using a named core substance, with varying numbers of attached propoxy groups (or propoxy and ethoxy groups). The properties of the core substance and the repeating unit should be reflected in the polyols. The repeating unit is essentially non-toxic. If there are toxic properties associated with a core substance, these properties should reduce with increasing numbers of repeating units (i.e. increasing molecular weight).If both the core substance and the repeating unit are non-toxic, it can be anticipated that there will be no toxicity in the polyol.
- Justification for type of information:
- Justification cf. field "any other information on results incl. tables"
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal register, August 22, 1978, 43:37359-60
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Oxy alkylation products of sucrose with propylenoxid
- Cas Number:
- 9049-71-2
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Oxy alkylation products of sucrose with propylenoxid
- Reference substance name:
- Sucrose, propoxylated
- EC Number:
- 500-029-3
- EC Name:
- Sucrose, propoxylated
- Cas Number:
- 9049-71-2
- Molecular formula:
- C12H14O11-(C3H6O)nH8 sum of n: >1 - <16.5 mol PO
- IUPAC Name:
- Sucrose, propoxylated
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ray Nicols Rabbitry, Lumberton, Texas
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as a control.
- Amount / concentration applied:
- TEST MATERIAL
1) Group A: 0.1 ml of the undiluted test substance was instilled into the conjunctival sac of the right eye of 6 rabbits
- 2) Group B: 0.1 ml of the undiluted test substance was instilled into the conjunctival sac of the right eye of 3 additional rabbits. Following 30-second exposure period these eyes were washed for 1 minute with tepid, flowing tape water. - Duration of treatment / exposure:
- 30 sec exposure
- Observation period (in vivo):
- 7 days post-instillation
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed and unwashed groups
SCORING SYSTEM:
Scoring system time points: 1, 2, 3, 4, and 7 days following instillation
TOOL USED TO ASSESS SCORE: penlight
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #2
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #3
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #4
- Time point:
- other: 24 hour
- Score:
- 2
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #5
- Time point:
- other: 24 hour
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #6
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #1
- Time point:
- other: 48 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #2
- Time point:
- other: 48 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #3
- Time point:
- other: 48 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #4
- Time point:
- other: 48 hour
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #5
- Time point:
- other: 48 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal #6
- Time point:
- other: 48 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal: 7
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal: 8
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- other: Primary Irritation Score
- Basis:
- animal: 9
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritant / corrosive response data:
- Group A (unwashed): slight redness of conjunctiva was observed 2/6 rabbits at 24 hours (group average score = 0.67) and 1/6 rabbits at 48 hours (group averaqge score = 0.33). No corneal injury was observed.
Group B (washed): no irritation and injury observed - Other effects:
- Upon instillation of test substance rabbits experienced slight to moderate discomfort, characterized by blinking and/or rubbing the eye with a paw. No irritation was observed 3 days post-instillation.
Any other information on results incl. tables
Annex XI of Regulation 1907/2006 and the REACH Guidance (R 6.2) permits the grouping of chemicals (chemicals categorisation).Barratt and Illing (2007, revised 2009a; 2009b, see attachmentsin section 13 of IUCLID data set) set out justification for an initial grouping of the polyols (oligomers and polymers) using a named core substance, with varying numbers of attached propoxy groups (or propoxy and ethoxy groups). The properties of the core substance and the repeating unit should be reflected in the polyols. The repeating unit is essentially non-toxic. If there are toxic properties associated with a core substance, these properties should reduce with increasing numbers of repeating units (i.e. increasing molecular weight).If both the core substance and the repeating unit are non-toxic, it can be anticipated that there will be no toxicity in the polyol.
A second round of grouping was based on allocation of the NLP polyols formed from different named core substances to one of two categories. The first group was those NLP polyols linked to the core substance by an ether linkage (category 1) and the second group (category 2) was those linked by a secondary/tertiary amine linkage. Category 1 consists of:
· Sucrose, propoxylated, >1-16.5 moles propoxylated
· propylidyne trimethanol, propoxylated, >1-6.5 moles propoxylated
· Glycerin, propoxylated, >1-6.5 moles propoxylated
· Propan-1,2-diol, propoxylated, >1-4.5 moles propoxylated
· Pentaerythritol, propoxylated, >1-8.5 mol propoxylated.
· Nitrilotriethanol, propoxylated, 1-6.5 moles propoxylated.
For details see attached documents ‘Grouping of NLP Polyols and their toxicokinetics assessments’ (Barratt and Illing (2007, revised 2009a) and PROPOSALS FOR FURTHER TESTING FOR THE NLP ‘POLYOLS’ (2009b) in section 13 of IUCLID data set.
The registered substance is a complex substance (UVCB) which can be regarded as a mixture of Sucrose, PO and Glycerin, PO, two members of the grouping "NLP polyols linked to the core substance by an ether linkage" (= category 1). As, in all cases, the ether linked NLP polyols are non-toxic, it is anticipated that any mixture of them or any co-initiated polyol formed using a mixture of initiators will have a similar lack of toxicity. Thus the hazard profile for the multicomponent substance can be sufficiently described by the information of the individual constituents and it is unnecessary to test this co-initiated polyol.
. The physico-chemical properties of these source substances and the target substance are very similar as displayed in Table 1 (test material is highlighted in yellow).
Table 1: Comparison of physico-chemical properties of source substances with target substance
|
|||
|
Source Substances |
Target Substance |
|
|
Glycerin + PO |
Sucrose + PO |
Glycerin + Sucrose + PO |
Appearance |
liquid |
liquid |
liquid |
Melting point |
no MP |
no MP |
no MP |
Boiling point |
Decomposition >= 290°C |
no BP |
Decomposition >= 210°C |
Relative density |
1.08 (20°C) |
1.122 (20°C) |
1.132 (20°C) |
Partition coefficient |
> -1.82 < -0.73 |
> -3.60 < -3.25 |
> -0.7 < 1.1 |
Water solubility |
completely miscible |
240 g/L (25°C) |
completely miscible |
Surface tension |
53 nM/m (20°C; at 1 mg/L) |
54.54 nM/m (20°C; at 1 mg/L) |
61.3 nM/m (20°C; at 1 mg/L) |
Flashpoint |
163°C (no information on pressure available) |
149.5°C (1003 hPa) |
198°C (1013 hPa) |
Auto flammability |
305°C (1014 ha) |
355°C (1000 hPa) |
350°C (1008 hPa) |
Flammability |
no pyrophoric properties |
no pyrophoric properties |
no pyrophoric properties |
Explosiveness |
no explosive properties |
no explosive properties |
no explosive properties |
Oxidising properties |
no oxidising properties |
no oxidising properties |
no oxidising properties |
Viscosity |
560.6 mPa (20°C) |
26.63 Pa s (20°C) |
21.47 mPa s (20°C) |
Therefore, in line with Annex XI, 1.2 of Regulation (EC) No 1907/2006, read-across (many-to-one) was chosen for the registered substance (Polyether Sucrose + Glycerin+ PO) and thus no toxicological study has been performed with registered substance itself.
The model being used to justify read-across (many-to-one) is that the toxicity of the polyether polyol is derived from the core substance (initiator) and the repeating unit. While for propoxylated polyols the repeating unit is probably not classifiable, any toxicological property requiring classification is derived from the core substance. The fact, that the target chemical is formed from core substances (Sucrose and Glycerol) which are the same for two source substances (Sucrose, PO and Glycerin, PO), suggests that there are no major differences between these source substances and the target substance which may affect the toxicological properties. Due to the closeness of the compounds, polyols grouping data (= source substances data) is lead for Polyether Sucrose + Glycerin + PO (= target substance) according to Table 2 (see section 13 of IUCLID data set).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is slightly irritating to the eye. The findings do not warrant classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.