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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-245-1 | CAS number: 314-40-9
- 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:
- February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- At the time of the present study (1998) the LLNA method was not established as standard method for the skin sensitization examination.
- Specific details on test material used for the study:
- Purity: 98.07%
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Housing: Animals were housed (1 animal/cage) in elevated stainless steel cages with wire mesh flooring.
The temperature ranged from 20°C - 23°C (68°F - 73°F) and the relative humidity ranged from 21 - 70%.
Food: Purina Certified Guinea Pig Diet #5026 was provided ad libitum.
Water: Supplied ad libitum. - Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.5 g
- Day(s)/duration:
- 0d/7d/14d/6h
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.5 g
- Day(s)/duration:
- 29d/6h
- No. of animals per dose:
- 20
- Details on study design:
- A 0.5 g portion of bromacil moistened with 0.5 mL of propylene glycol was applied to a 25-mm Hill Top Chamber™, placed on the test site, and covered with a piece of dental dam (approximately 2 inches x 2 inches). After positioning the chamber and the occlusive dental dam on the prepared skin site, plastic wrap was
wrapped snugly around the trunk of the animal and overwrapped with Elastikon ™. Approximately 6 hours after application, the entire wrapping was removed, and the test sites were wiped with propylene glycol and then deionized water. This procedure was performed at 7-day intervals for three consecutive weeks. - Positive control substance(s):
- yes
- Remarks:
- A positive control is periodically tested at White Eagle Labs in order to document the effect of a weak sensitizer in this test system. As sensitizer alpha-hexylcinnamaldehyde, technical grade, 85% was used.
- Positive control results:
- The test article, alpha-Hexylcinnamaldehyde, technical, 85% (HCA) when induced at a 2.0% w/v concentration and challenged at 1.5% w/v concentration at a dose level of 0.5 mL, is a dermal sensitizer in albino guinea pigs.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 13
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 14
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 13
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 14
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g bromacil and 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 21
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 23
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 26
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 27
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 28
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 21
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 23
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 26
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 27
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 28
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- lt was concluded that repeated administration of bromacil did not produce delayed contact hypersensitivity in guinea pigs under the study conditions utilized.
- Executive summary:
The test article bromacil when induced and challenged at a dose level of 0.5 g of test article moistened with 0.5 mL of propylene glycol (considered 100%), is not a dermal sensitizer in albino guinea pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Repeated administration of bromacil did not produce delayed contact hypersensitivity in guinea pigs under the study conditions utilized and so it is not classified as sensitizer.
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.