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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 402-030-3 | CAS number: 624-86-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guidelines with acceptable restrictions (no concurrent nor historical positive controls, no data on substance purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (no concurrent nor historical positive controls, no data on substance purity)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A well-conducted and fully reported sens study conducted in 1987 is available that can be used for the purposes of classification and labelling as well as risk assessment. Conducting further testing is not considered adequate.
Test material
- Reference substance name:
- O-ethylhydroxylamine
- EC Number:
- 402-030-3
- EC Name:
- O-ethylhydroxylamine
- Cas Number:
- 624-86-2
- Molecular formula:
- C2 H7 N O
- IUPAC Name:
- O-ethylhydroxylamine
- Details on test material:
- - CTL reference number: Y05460/002/001
- Name of test substance as cited in report: Substance H109360
- Identification of test sample as cited in report: 50% (w/v) aqueous solution (45% Substance H109360 and approximately 5% ethanol)
- Appearance: clear aqueous solution
- Lot #: EFI-100
- Analytical purity: not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: The Animal Breeding Unit, Imperial Chemical Industries PLC, Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire, UK.
- Weight at study initiation: 317-375 g
- Housing: individually in suspended cages (37cm length x 32cm width x 20cm height)
- Age at study initiation: not specified
- Diet: ad libitum: Labsure RGP Guinea Pig diet
- Water: ad libitum, via automatic system
- Acclimation period: minimum of 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 40-50
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 3%
- Epicutaneous induction: 10%
- Challenge: undiluted and 30%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 3%
- Epicutaneous induction: 10%
- Challenge: undiluted and 30%
- No. of animals per dose:
- - Control: 10
- Test groups: 20 - Details on study design:
- JUSTIFICATION FOR CHOICE OF CONCENTRATIONS
- Based on results of range finding test
RANGE FINDING TESTS (RFT): Intradermal injection
- No. of animals: at least 2 animals/dose
- Concentrations: upto 10% (up to 4 doses)
- Vehicle: Water
RANGE FINDING TESTS (RFT): Epicutanous application
- No. of animals: at least 2 animals/dose
- Vehicle: water
MAIN STUDY
A INDUCTION EXPOSURE
Intradermal injection
- Site: scapular region (5 x 5 cm)
- Test substance group: (Top): Freund's complete adjuvant (FCA) plus water 1:1
- Test substance group: (Middle): The test article in vehicle
- Test substance group: (bottom): Freund's complete adjuvant and test article in vehicle (1:1)
- Control group (Top): Freund's complete adjuvant (FCA) plus vehicle 1:1
- Control group (middle): Vehicle
- Control group (bottom): Freund's complete adjuvant plus vehicle (1:1)
- Concentrations: 3%
- Volume per injection: 0.05-0.1 ml
Epicutaneous induction exposure
- Time schedule: 7 days after intradermal injection
- Site: same as intradermal injection
- Method of test substance application: on 2 x 4 cm filter paper
- Type of coverage: occlusive (adhesive elastic bandage (approximate size 20-30cm x 5cm))
- Concentrations: 10%
- vehicle: water
- Volume applied: 0.2-3.0 ml applied on filter paper
- Duration: 48 hours
B. CHALLENGE EXPOSURE (test group and control animals treated alike)
- Time schedule: 14 days after termination of induction exposure
- Site: left flank (test substance; undulited) right flank (30% in vehicle)
- Area of application: 1 x 1-2 cm
- Concentrations: undiluted test sample and 30% in vehicle
- Vehicle: water
- Volume applied: 0.5 ml/animal
- Type of coverage: Occlussive coverage with a strip of adhesive bandage (approximate size 25-40cm x 1 .5cm) and secured with self-adhesive PVC tape
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure
SCORINGS SYSTEM:
- 0: no reaction
- 1: scattered mild redness
- 2: moderate diffuse redness
- 3: intense redness and swelling - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 3.0. Total no. in groups: 19.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 2.0. Total no. in groups: 19.0. Clinical observations: not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: not reported.
Any other information on results incl. tables
One test animal was not included in the final assessment as the bandage had slipped during the challenge application (no erythema was seen on this animal.
3/19 animals of the test substance group (approx.16%) was regarded as sensitized. This is below the threshold of 30% required for classification according to the 67/548/EEC Annex VI.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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.