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EC number: 425-150-8 | CAS number: 94723-86-1
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 425-150-8
- EC Name:
- -
- Cas Number:
- 94723-86-1
- Molecular formula:
- C15 H22 O3 S
- IUPAC Name:
- 2-butanoyl-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one
- Details on test material:
- - Name of test material (as cited in study report): 625-Triketone
- Substance No.: 95/225-1
- Physical state: Powder, beige
- Analytical purity: 99.4 %
- Lot/batch No.: LJ 27881/1
- Date of manufacturing: 18-27 Jul 1995
- Stability under test conditions: guaranteed by the sponsor and verified by reanalysis
- Storage condition of test material: refrigerator
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Strain/Quality: Pirbright White, Dunkin Hartley Crl: (HA) BR [SPF]
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight; 255 - 344 g
- Fasting period before study: none
- Housing: single housing
- Diet: KLIBA-Labordiaet 341, Klingenthalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days before the beginning of the study in the laboratory for dermal toxicity
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Analysis of drinking water
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of the BASF AG as well as for the presence of germs by a contract laboratory.
Analysis of feed:
The feed used in the study was assayed for chemical and microbial contaminates.
Analysis of the bedding :
The bedding is regularly assayed for contaminants (chlorinated hydrocarbons, heavy metals).
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction:
5 % test substance in olive oil DAB 10
5 % test substance in Freund’s adjuvant/0.9 % aqueous NaCl-solution (1:1)
Freund’s adjuvant/0.9 % aqueous NaCl-solution (1:1)
olive oil DAB 10
Percutaneous induction:
50 % test substance in olive oil DAB 10
olive oil DAB 10
Challenge:
25 % test substance in olive oil DAB 10
olive oil DAB 10
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction:
5 % test substance in olive oil DAB 10
5 % test substance in Freund’s adjuvant/0.9 % aqueous NaCl-solution (1:1)
Freund’s adjuvant/0.9 % aqueous NaCl-solution (1:1)
olive oil DAB 10
Percutaneous induction:
50 % test substance in olive oil DAB 10
olive oil DAB 10
Challenge:
25 % test substance in olive oil DAB 10
olive oil DAB 10
- No. of animals per dose:
- Test group: 10 animals
Control group 1: 5 animals
Control group 2: 5 animals - Details on study design:
- RANGE FINDING TEST
The concentrations of the test substance suitable for use in the main experiment were determined in a pretest. After two 24-hour percutaneous occlusive applications within 96 hours, the minimum irritant concentration was found to be a 50 % test substance preparation in olive oil DAB 10. The maximum non-irritant concentration was found to be a 25 % test substance preparation in olive oil DAB 10 (24 and 48 hours after application) .
Applicability: it was possible to inject a 5 % test substance preparation in olive oil DAB 10 resp. in
Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) with a syringe. The following concentration for induction and the challenge were selected on the basis of the pretests:
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction
- No. of exposures: single exposure with 6 intradermal injections in groups of two per animal
- Test groups: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1/ 2 injections each of 0.1 ml of the test substance fomulation/ 2 injections each of 0.1 ml Freund's adjuvant emulsified with 0.9% aqueous NaCl-solution (1 : 1) with test substance
- Control groups: same injections but without test substance
- Site: shoulder
- Readings: 24 h after beginning of the application
Percutaneous induction
Percutanous induction was carried out one week after intradermal induction
- No. of exposures: single exposure
- Exposure period: 48 h
- Test groups: test substance in olive oil DAB10 under occlusive dressing
- Control groups: olive oil DAB10 under an occlusive dressing
- Site: shoulder, same area as for intradermal injection
- Readings: 48 h after beginning of the application
B. CHALLENGE EXPOSURE
Challenge was performed 21 days after intradermal exposure.
- No. of exposures: single exposure
- Exposure period: 24 h
- Test groups: test substance in olive oil DAB10 under an occlusive dressing
- Control groups: olive oil DAB10 under an occlusive dressing
- Site: intact flank of the animals
- Evaluation (hr after challenge): 24 h and 48 h after removal of the patch - Challenge controls:
- Control groups only received olive oil DAB 10 during the induction phase. At challenge control group 1 was treated analogous to the test group, control group 2 only received olive oil DAB 10.
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde 85 % (A positive control with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.)
Results and discussion
- Positive control results:
- Control group 1:
1. challenge (50 % test substance in olive oil DAB10): 2/10
2. challenge (50 % test substance in olive oil DAB10): 3/10
Control group 2:
1. challenge (olive oil DAB10): 2/10
2. challenge (50 % test substance in olive oil DAB10): 1/10
test group:
1. challenge (50 % test substance in olive oil DAB10): 13/19
2. challenge (50 % test substance in olive oil DAB10): 14/19
x/y = number of animals showing symptoms / total number of treated animals in the respective dose group
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 3.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
Any other information on results incl. tables
treatment | group | formulation | symptoms | number of positive reactions/number of animals tested |
Intradermal induction | Test group | Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) | well-defined erythema and slight edema | 10/10 |
5 % 625-Triketone in olive oil DAB 10 | well-defined erythema and slight edema | 10/10 | ||
5 % 625-Triketone in Freund's adjuvant/0.9% aqueous NaC1-solution (1 : 1) | well-defined erythema and slight edema | 10/10 | ||
Control group 1+2 | Freund's adjuvant/0.9% aqueous NaC1-solution (1 : 1) | well-defined erythema and slight edema | 10/10 | |
Olive oil DAB 10 | well-defined erythema | 10/10 | ||
Percutanous induction | Test group | 50 % 625-Triketone in olive oil DAB 10 | incrustation (partially open), well-defined erythema and slight edema | 10/10 |
Control group 1+2 | Olive oil DAB 10 | incrustation (partially open), well-defined erythema and slight edema | 10/10 | |
Challenge | Test group: | 25 % test substance in olive oil DAB10 | very slight to well-defined erythema | 4/10 |
Olive oil DAB 10 | - | 0/10 | ||
Control group 1 | 25 % test substance in olive oil DAB10 | - | 0/4 | |
Olive oil DAB 10 | - | 0/4 | ||
Control group 2 | Olive oil DAB 10 | - | 0/3 |
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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