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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 260-252-4 | CAS number: 56539-66-3
- 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
Carcinogenicity
Administrative data
Description of key information
no study available, however, based on the results of available repeated dose toxicity studies it has been concluded that there is no indication of carcinogenicity
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- A carcinogenicity study is listed in Column 1 (standard information required) of Annex X (8.9.1) of the REACH Regulation, but is not usually required. Column 2 (specific rules for adaptation from Column 1) of Annex X states that a carcinogenicity study may be proposed (by the registrant) or requested (by ECHA) if:
(1) the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and;
(2) the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
For the registered substance, the supported uses include widespread dispersive use, with the potential for frequent or long-term human exposure. However, in order for a carcinogenicity study to be proposed (or required), the hazard profile of the substance also needs to be considered.
Specifically, there is no evidence of genotoxic effects in studies in vitro (OECD 471, OECD 476, OECD 473), demonstrating that the substance does not cause gene mutations or chromosomal aberrations. Consequently, testing in vivo is not required, and the substance is not classified (or proposed to be classified) as Mutagen Category 2.
The key study for repeated dose toxicity is the 90-day oral toxicity (OECD 408). This study used dose levels of up to 1000 mg/kg bw/d, and included histopathological assessment of the adrenals, gross lesions, aorta, brain (including medulla/pons, cerebellar and cerebral cortex), caecum, colon, duodenum, epididymides, eyes with optic nerve and Harderian gland, femur with knee joint, heart, ileum (including Peyer´s patches), jejunum , kidneys, liver, lungs, lymph nodes (mandibular, mesenteric, axillary), mammary gland (male and female), oesophagus, ovaries, oviducts, pancreas, pituitary, prostate and seminal vesicles with coagulating glands, rectum, salivary glands (sublingual, submandibular), sciatic nerve, skeletal muscle, skin , spinal cord (cervical, thoracic and lumbar segments), spleen, sternum (with bone marrow), stomach, testes, thymus, thyroid gland including parathyroid glands, tongue, trachea, ureters, urinary bladder, uterus with cervix and vagina. The study did not identify any treatment-related hyperplastic or pre-neoplastic lesions. Microscopic treatment-related findings were limited to the liver of females at 250 and 1000 mg/kg bw/d. These rats showed an increase of inflammatory cell foci in the liver. In the absence of necrosis, Kupffer cell proliferation, apoptosis, fibrosis, alteration in liver function and no significant increase in serum ALT or AST activities, this finding was considered to be of a non-adverse.
ECHA REACH Guidance (Chapter R.7a; R.7.7.13.2) states that ‘For substances for which there is no concern for mutagenic activity, and no other toxicological indicators of concern for carcinogenicity (i.e. for the substance itself or for structurally-related substances), there is no need for further consideration of its carcinogenic potential. This applies equally to those substances at the Annex X tonnage level as to those at lower tonnage levels.’ The Guidance further states that ‘for non-genotoxic substances, toxicological indicators of concern are available (e.g. hyperplastic or pre-neoplastic lesions in repeated dose toxicity studies of the substance itself and/or of closely related substances), they should be investigated further on a case-by-case basis. Any decision on further testing is dependent upon the type and strength of the indications for carcinogenicity, the potential mechanism of action and their relevance to humans, and the type and level of human exposure.’
For the registered substance, in the absence of any evidence of genotoxic activity and in the absence of any evidence of hyperplastic or pre-neoplastic lesions in repeated dose toxicity studies, it can be concluded that there is no indication of carcinogenicity. Consequently, a carcinogenicity study is not scientifically justified and is not proposed for the substance. This is consistent with Column 2 of Annex X and Article 25 of the REACH Regulation, which states that animal testing shall be undertaken only as a last resort.
Reference
Justification for classification or non-classification
Carcinogenicity studies have not been conducted for MMB.
However, in the absence of any evidence of genotoxic activity and in the absence of any evidence of hyperplastic or pre-neoplastic lesions in repeated dose toxicity studies, it can be concluded that there is no indication of carcinogenicity. Consequently, a carcinogenicity study is not scientifically justified and is not proposed for the substance. This is consistent with Column 2 of Annex X and Article 25 of the REACH Regulation, which states that animal testing shall be undertaken only as a last resort.
Additional information
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.