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EC number: 443-800-9 | CAS number: 40031-31-0
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 October-6 November 1994
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Method B6 of Commission Directive 92/69/ EEC (which constitutes Annex V of Council Directive
67/548/EEC) - Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA or the MEST methods can be used as a first stage in the assessment of skin sensitisation potential. If a positive result is seen in either assay, a test substance may be designated as a potential sensitiser, and it may not benecessary to conduct a further guinea pig test. However, if a negative result is seen in the LLNA or MEST, a guinea pig test (preferably a GPMT or Buehler Test) must be conducted
Test material
- Reference substance name:
- -
- EC Number:
- 443-800-9
- EC Name:
- -
- Cas Number:
- 40031-31-0
- Molecular formula:
- C4H8O4
- IUPAC Name:
- (3S)-1,3,4-trihydroxybutan-2-one
- Test material form:
- liquid: viscous
- Details on test material:
- NA
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Age: approx. 8 to 12 weeks old
Body weight: 360 435 g
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's Complete Adjuvant and distilled water
- Concentration / amount:
- Induction of the Test Animals:
i ) Freund's Complete Adjuvant plus distilled water in the ratio 1: 1.
i i ) a 20% w/ v dilution of test material in distilled water.
i i i ) a 20% w/ v dilution of test material in a preparation of Freund's Complete Adjuvant plus distilled water. - Day(s)/duration:
- 24h,48h
Challenge
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's Complete Adjuvant and distilled water
- Concentration / amount:
- 10, 20% v/ v in distilled water
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- Preliminary study: 4 females
Experimental group; 20 females
Control group: 10 females - Details on study design:
- Main Study
a) Induction of the Test Animals:
i ) Freund's Complete Adjuvant plus distilled water in the ratio 1: 1.
i i ) a 20% w/ v dilution of test material in distilled water.
i i i ) a 20% w/ v dilution of test material in a preparation of Freund's Complete Adjuvant plus distil led water.
Approximately 24 and 48 hours after intradermal injection the degree of erythema at the test material injection sites (i . e.
injection site i i ) was evaluated according to the scale shown in Appendix X.
One week l ater (Day 7) , the same area on the shoulder region used previously for intradermal injections was cl ipped again and treated with a topical appl ication of the test material formulation (20% v/ v in distilled water) . The test material formulation was appl ied to saturation on filter paper (WHATMAN No.4: approximate size 40 mm x 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 50 mm x 30 mm) and covered with an overl apping length of aluminium foil . The patch and foil were further secured by a strip of elastic adhesive bandage ( ELASTOPLAST : approximate size 250 mm x 35 mm) wound in a double layer around the torso of each animal . This occlusive dressing was kept in place for 48 hours.
The degree of erythema and oedema was quantified one and twentyfour hours following removal of the patches using the scale shown in Appendix X.
Any other reaction was also recorded. - Challenge controls:
- Shortly before treatment on Day 21, an area, approximately 50 mm x 70 mm on both flanks of each animal , was clipped free of hair with veterinary cl ippers. A quantity of the test material formulation (20% v/ v in distilled water) was applied to saturation to the shorn right flank of each animal on a square of filter paper (WHATMAN No. 4: approximate size 20 mm x 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 40 mm x 50 mm) .
To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 10% v/ v in distilled water was also similarly applied to a separate skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 75 mm) wound in a double layer around the torso of each animal .
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- Positive control material: Alpha-Hexylcinnamaldehyde Tech. 85% Induction Intradermal: 25% in arachis oil Induction Topical: 100% and 75% in arachis oil
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- Positive control material: 2-Mercaptobenzothiazole Induction Intradermal: 10% in arachis oil Induction Topical: 50% and 95% in aqueous ethanol
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- Positive control material:Ethyl 4-aminobenzoate 98% Induction Intradermal: 3% in a 6% preparation of acetone in arachis oil Induction Topical: 25% and 80% in aqueous ethanol
- No. with + reactions:
- 7
- Total no. in group:
- 18
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- Positive control material: 2,4-Dinitrochlorobenzene Induction Intradermal: 0.1% in arachis oil Induction Topical: 0.1% and 0.05% in arachis oil
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since no skin reactions were observed in the challenge, it can be concluded that no sensitisation reaction occurred.
The test material has been classified as a NON-SENSITISER to guinea pig skin. - Executive summary:
Since no skin reactions were observed in the challenge, it can be concluded that no sensitisation reaction occurred.
The test material has been classified as a NON-SENSITISER to guinea pig skin.
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