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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 261-767-7 | CAS number: 59447-55-1
- 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
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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/2/2004-15/03/2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- deviations from the minimum level of temperature occurred. Based on laboratory historical data, deviations were considered not to have affected the study integrity.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- deviations from the minimum level of temperature occurred. Based on laboratory historical data, deviations were considered not to have affected the study integrity.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- deviations from the minimum level of temperature occurred. Based on laboratory historical data, deviations were considered not to have affected the study integrity.
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River FRance, L'Abresle Cedex, France
- Age at study initiation: +/- 10weeks
- Weight at study initiation: /
- Housing:Individual in labelled Macrolon cages (type I: height 12.5cm) containing purified sawdust as bedding material.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days i groups in polycarbonate cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17.9-23.1°C
- Humidity (%): 41-64%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light
IN-LIFE DATES: From: To: - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test: 100%, 50%, 25%, 10%, 5%, 2.5%, 1%
Main study: 5%, 25%, 50% - No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
The highest test substance concentration selected for the main study was a 50% concentration
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: SI >= 3
TREATMENT PREPARATION AND ADMINISTRATION:
Induction (Days 1,2,3):
Experimental animals:
The dorsum surface of both ears was epidermally treated (25μl/ear) with the test substance concentration, at approximately the same time each day.
Vehicle control animals:
The control animals were treated the same as the experimental animals, except that, instead of the test substance, the vehicle alone was administered.
Treatment Day 6:
All animals; Each animal was injected via the tail vein with 0.25ml of sterile phosphate buffered saline (PBS) containing 20μCi of 3H-methyl thymidine.
After approximately five hours, all animals were killed by intr peritoneal injection with an overdose of pentobarbital. The draining lymph node of each ear was excised. The relative size of the nodes was estimated by visual examination and abnormalities of the nodes were recorded. The nodes were pooled for each animal in 3ml PBS. - Statistics:
- If possible an EC3 value was determined, using linear interpolation
- Positive control results:
- /
- Parameter:
- SI
- Remarks on result:
- other: SI values for the substance concentrations 5, 25 and 50% were 8.8, 15.0, 3.5 respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: MEAN DPM/animal values were 1181, 2020 and 471 for resp. 5, 25 and 50% test substance respectively
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The SI values calculated for the substance concentrations 5, 25 and 50% were 8.8, 15.0 and 3.5 respectively. These data showed a dose-response and it was considered that there is sufficient evidence that the substance elicts a SI >=3. No EC value could be calculated.
Based on these results and according to the recomendations made in the test guidelines, PBB-MA should be regarded as a skin sensitizer. - Executive summary:
Test substance concentration selected for the main study were based on the results of a preliminary study. In the main study, three groups of five experimental animals were epidermally exposed to a 5%, 25% and 50% concentration respectively on three consecutive days. Five vehicle control animals were similarly treated, but with vehicle alone (acetone/olive oil (4:1 v/v).
Three days after the last exposure, all animals were injected with H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were done.
The majority of nodes were equal in size, except for the nodes of some animals of the 5% and 25% groups.
Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 25 and 50% were 1181, 2020 and 471 respectively. The mean DPM/animal value for the vehicle control group was 135.
The SI values calculated for the susbtance concentrations 5, 25 and 50% were 8.8, 15.0 and 3.5 resp.
These data showed a dose-response and it was considered that there is sufficient evidence that the substance elicts a SI>=3. No EC3 value could be calculated.
Based on OECD 429, EC B.42 and OPPTS 870.2600, PBB-MA should be regarded as a skin sensitiser.
Reference
Induction phase: No irritation was observed in any of the animals examined.
Macroscopy: The majority of nodes were equal in size, except for the nodes of some animals of the 5% and 25% groups. No other macroscopic abnormalities of the nodes were noted.
Body weights: Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Migrated from Short description of key information:
The SI values calculated for the substance concentrations 5, 25 and 50% were 8.8, 15.0 and 3.5 respectively. These data showed a dose-response and it was considered that there is sufficient evidence that the substance elicts a SI >=3. No EC value could be calculated.
Justification for selection of skin sensitisation endpoint:
Most sensitive study
Justification for classification or non-classification
According to the CLP-Regulation (EC) No 1272/2008, FR-1025M is classified as a skin sensitizer category I as at 10% concentration, the SI= 4.1 > 3 and is thus larger than the value set in the CLP regulation. It is classified as a moderate skin sensitizer as the EC3 value (%w/v) is larger than >2.
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.