Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 439-070-6 | CAS number: 125005-87-0
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Fully reported evaluation of irritancy on skin not following EC B.4 method but with longer skin contact times.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Evaluation of skin irritation in the Guinea pig: trial to determine suitable challenge concentrations for use in a subsequent skin sensitisation assay.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 439-070-6
- EC Name:
- -
- Cas Number:
- 125005-87-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- (2R,3R,4S,5S)-2,3,4,5-tetrahydroxyhexanal (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanal (2S,3S,4S,5R)-2,3,4,5-tetrahydroxy-6-oxohexanoic acid acetic acid calcium dihydride hydrate magnesium dihydride potassium hydride sodium hydride
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Details on test animals or test system and environmental conditions:
- Male Guinea pigs 300-450g weight, housed singly or in pairs in solid-floor cages with woodflake bedding and free access to food and water. 12 hour light/dark cycle in animal room with target conditions 17-23 degrees C and 30-70% RH.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: dried Arachis oil
- Controls:
- not required
- Amount / concentration applied:
- Four different concentrations at separate sites on the clipped flanks: 5,10,25,50% (50% = maximum attainable concentration for topical application).
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 1,24 and 48 hours after dressing removal.
- Number of animals:
- 2
- Details on study design:
- Test substance in vehicle applied on a saturated filter paper patch (circa 20 x 20 mm square) held against the skin by surgical adhesive tape and covered with aluminium foil under an adhesive bandage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No oedema observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No oedema observed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- max test concentration, 50%
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Remarks:
- No observations after 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- max test concentration, 50%
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- max test concentration, 50%
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- max test concentration, 50%
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Remarks:
- No observations after 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- max test concentration, 50%
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No oedema observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- max test concentration, 50%
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No oedema observed
Any other information on results incl. tables
A separate skin irritation trial was also performed to determine a suitable concentration for application during the induction phase of the Guinea pig sensitisation study: all aspects of this were identical to those of the challenge concentrations trial described here, except that the two test animals had been injected with Freund's Complete Adjuvant 15 days earlier and the occluded topical applications were maintained for 48 hours. In this trial, erythema scores for the maximum 50% test concentration were 2, 1, 0 (animal 1) and 2, 1, 1 (animal 2) at 1, 24 and 48h respectively. Oedema scores were zero at 1, 24 and 48h.
Applicant's summary and conclusion
- Interpretation of results:
- other: The prolonged period of occluded skin contact employed in the tests described (24-48h, compared to 4h in the B.7 method) is considered to compensate for the use of a maximum 50% concentration.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Not classified for skin irritation under EU criteria.
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.