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EC number: 445-630-0 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-04-16 - 2003-06-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 445-630-0
- EC Name:
- -
- Molecular formula:
- Unspecified
- IUPAC Name:
- 1-(acetyloxy)but-3-en-2-yl acetate; 2-hydroxybut-3-en-1-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Vinylglykoldiacetat ca. 75 %ig
- Test substance No.: 02/0526-1
- Physical state: Liquid / colorless, clear
- Analytical purity: 74.8 area% (73.3 g/100 g)
- Other constituents:
4-Acetoxy-3-hydroxy-1-butene and 2-Acetoxy-1-hydroxy-1-butene: 17.3 area-%.(17.0 g/100 g)
3,4-Diacetoxy butane: 2.0 area-% (2.0 g/100 g)
1-Acetoxy-2-hydroxy butane: 0.8 area-% (0.8 g/100 g)
2-Acetoxy-1-hydroxy butane : 0.4 area-% (0,3 g/100 g)
4-Acetoxy crotonaldehyd: 1.8 area-% (1.8 g/100 g)
- Lot/batch No.: Kanister 1, 2, 4, 5
- Date of production: Oct. 21, 2001
- Stability under test conditions: The stability under storage conditions was confirmed by reanalysis
- Storage condition of test material: Room temperature, exclusion of oxygen (storage under nitrogen)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc: DH (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, FRG
- Identification: ear tattoo
- Age at study initiation: about 5 weeks
- Weight at study initiation: 255 g – 321 g
- Housing: 5 per cage in stainless steel wire mesh cages with plastic-coated grating, minimum floor area: 2,000 cm2
- Diet (e.g. ad libitum): Kliba Labordiät (Kaninchen/ Meerschweinchen-Haltungsdiät) Provimi Kliba SA, Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 6 days before the first test substance application.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 5%
Epicutanous induction: 100%
Challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 5%
Epicutanous induction: 100%
Challenge: 100%
- No. of animals per dose:
- 10 (test group), 5 (control group)
- Details on study design:
- RANGE FINDING TESTS:
Intradermal Pretest:
- Amount applied: 6 intradermal injections in groups of two per animal were applied to each animal.
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 ml of a test substance formulation in an appropriate vehicle at the selected concentration
C) back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCI-solution (1 : 1) with test substance at the selected concentration.
- Site of application: neck region
- No. of animals: 2 per test substance concentration
- Reading: 24 h after the beginning of application
Epicutaneous Pretest:
- Amount applied: 2 x 2 cm gauze patches (6 Iayers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing 0.5 ml of the test substance were applied to the skin of the flanks under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
- Duration of exposure: 24 h
- Site of application: flank
- Number of test animals: 3
- Readings:1 h, 24 h and 48 h after removal of the patches
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 intradermal injections in groups of two per animal were given:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 ml of a test substance formulation in an appropriate vehicle at the selected concentration
C) back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCI-solution (1 : 1) with test substance at the selected concentration.
- Epicutaneous induction was carried out one week after intradermal induction:
2 x 4 cm gauze patches (6 Iayers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing 1 ml of test substance were applied to the skin of the neck region under an occlusive dressing for 48 h. The dressing consisted of rubberized linen patches (4 x 6 cm from Russka) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
- Test group: 10 animals
- Control group: 5 animals
B. CHALLENGE EXPOSURE
- No. of exposures: 1, 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test substance were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
- Day(s) of challenge: 14 days after the epicutaneous induction.
- Exposure period: 24 h
- Test group: 10 animals
- Control group: 5 animals
- Site: flank
- Concentrations: 0.5 ml, 100%
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch
EVALUATION
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 30 per cent of the test animals exhibit skin reactions in this adjuvant test.
The evaluation is based an the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place an the date of report signature. - Positive control substance(s):
- no
- Remarks:
- A positive control (reliability check) was performed as separate study twice a year in the laboratory using alpha-hexylcinnamaldehyde techn. 85%. The test system was shown to be able to detect sensitizing compounds under the test conditions chosen.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema in 2 test group animals; moderate and confluent erythema in 2 test group animals; moderate and confluent erythema and dry skin in 1 test group animal
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema in 2 test group animals; moderate and confluent erythema in 2 test group animals; moderate and confluent erythema and dry skin in 1 test group animal.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema and scaling in 3 test group animals; moderate and confluent erythema and scaling in 1 test group animal
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema and scaling in 3 test group animals; moderate and confluent erythema and scaling in 1 test group animal.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Additional results:
- the test substance caused a yellow-brown discoloration of the application area, however this did not impair evaluation of erythema formation.
- body weights: The expected body weight gain was generally observed in the course of the study.
Applicant's summary and conclusion
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.
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