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Diss Factsheets
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EC number: 203-696-6 | CAS number: 109-69-3
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study without deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- Evaluation 24, 48 and 72 hours after challenge
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Harlan-Winkelmann, Borchen, Germany
- Age at study initiation: healthy young adults
- Weight at study initiation: 436 - 527 g
- Housing: conventional, max. 5 animals per cage (Makrolon Type IV)
- Diet: Ssniff G 4 ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 -70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- Conc. 50 % (w/w) in maize oil (MEH 56) (induction and challenge)
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- Conc. 50 % (w/w) in maize oil (MEH 56) (induction and challenge)
- No. of animals per dose:
- Test group: 20
Controls: 10 - Details on study design:
- Application volume: 0,4 mL
RANGE FINDING TESTS: 2,5; 25; 50% (w/w) in maize oil (MEH 56) and 100% (w/w)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Induction on days: 0, 7, 14
- Concentration: 50% (w/w) in maize oil (MEH 56)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Challenge on day: 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentration: 50% (w/w) in maize oil (MEH 56)
- Evaluation (hr after challenge): 24, 48 and 72
- Positive control substance(s):
- yes
- Remarks:
- 1-Chlor-2,4-dinitrobenzol (HS-92/CDNB-1; 25.04.1993 - 27.05.1993)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: not sensitizing
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a GLP-guideline study according to OECD 406 the sensitation potential to guinea pig skin of 1-chlorobutane was examined (Buehler Test). 20 female Dunkin Hartley guinea pigs were induced with 50% n-butyl chloride in maize oil MEH 56 (w/w) by epidermal application on days 0, 7 and 14 for 6 hours. 10 guinea pigs served as control. 24 hours after the third induction exposure 6 animals exhibited slight to precisely defined skin irritations and another animal developed moderate edema and erythema. Following a rest period of 14 days the animals were exposed to the challenge dose (50% 1-chlorobutane in maize oil (w/w)). 24, 48 and 72 hours after challenge none of the animals showed changes at the exposed skin areas. Systemic toxic effects could not be detected. The general condition and body weight development of the test animals were not affected.
Migrated from Short description of key information:
-guinea pig (Buehler test): not skin sensitising (93-0264-DGT)
Justification for selection of skin sensitisation endpoint:
One study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
The data is conclusive but not sufficient for classification according to DSD (67/548/EEC) and CLP (1272/2008/EC).
Respiratory sensitisation:
CLP: Classification is not possible due to data lacking.
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