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Diss Factsheets
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EC number: 249-636-2 | CAS number: 29450-45-1
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8.09.2006 - 30.11.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
- Objective of study:
- metabolism
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (4-chloro-2-methylphenoxy)acetic acid
- EC Number:
- 202-360-6
- EC Name:
- (4-chloro-2-methylphenoxy)acetic acid
- Cas Number:
- 94-74-6
- Molecular formula:
- C9H9ClO3
- IUPAC Name:
- (4-chloro-2-methylphenoxy)acetic acid
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- 4-chloro-o-cresol
- EC Number:
- 216-381-3
- EC Name:
- 4-chloro-o-cresol
- Cas Number:
- 1570-64-5
- Molecular formula:
- C7H7ClO
- IUPAC Name:
- 4-chloro-2-methylphenol
- Test material form:
- solid
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- MCPA technical
Test substance MCPA Technical with a chemical purity of 97.2 %, was produced by Zaklady Chemiczne „Organika-Sarzyna" S.A. The compound was kept at laboratory temperature.
Radiolabeled MCPA:
14C-MCPA (4-chloro-2-methylphenoxy)-[14C] acetic acid) was synthesized with the carbon label at the 1-position of the acetic moiety. It was prepared by Institute of Isotopes Co., Ltd., Budapest, Hungary. [14C]-MCPA had specific activity 2062 mBq/mmol. The radiochemical purity was mm 98 %. The isotope was kept frozen at minus 15°C. - Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- The Wistar strain rats were obtained from Velaz ( Praha, Czech Republic). A body weight in quarantine was within the range 140 - 160 g (Protocols No. 17/2006 and 19/2006).
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Details on exposure:
- Rats were administered a single oral dose of 14C-MCPA at 5 and 100 mg.kg-1. Suspension of a substance was added in syringe by gavage with metal probe. Mass of 1 mg MCPA (dose 5 mg*kg-1) or 20 mg (dose 100 mg*kg-1) was dissolute in 0.5 ml of 48% ethanol in which was added 14C-MCPA to provide volume of 2.5 ml*kg-1 for both doses.
The nominal radioactive quantity of 14C-MCPA at all test doses was 50 µCi/kg-1, which approximately 10 µCi per 200 mg of body weight is contained in a volume of 0.5 ml of administered solution. Volume of administrated solution in all cases was below 1 ml.
Rats directly before starting of experiment were weighted and applied volume of dose suspension was calculated on a body weight.
Stability: Both low and high doses 14C-MCPA preparations are found to be stable and homogeneous for at least 24 h. All 14C-MCPA doses are administered within approximately 18 h of preparation.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- MCPA is degraded with elimination half-life 6.5 at low dose and 11 h at high dose.
- Type:
- distribution
- Results:
- It has demonstrated that MCPA does not trend to be stored or accumulated in tissues.
- Type:
- metabolism
- Results:
- MCPA circulated in blood as unchanged form (RT=6.9 min). It was excreted by urine mainly as parent compound and two metabolites; its 2-hydroxy derivative HMCPA with RT=2.6 mm and unidentified metabolite with RT=6 min.
- Type:
- excretion
- Results:
- More than 90% of the initial dose of MCPA was eliminated by urine during 24 h at low dose and 48 h at high dose.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- These results indicate that substance is rapidly absorbed from the gut in rats. Peak plasma concentration was achieved within Tmax. 4 – 6 h. Comparison of the plasma peaks Cmax between two dose levels shows 16-fold increase and 50-fold for AUC0 ∞ at high dose. Despite this, the more than proportional increase of the AUC indicated that excretion of MCPA is retarded at the high dose. It is degraded with elimination half-life 6.5 at low dose and 11 h at high dose.
- Details on distribution in tissues:
- Target organs were kidney that is associated with a renal excretion route, and skin. All tissue levels were low (< 0.4 % for the low dose and < 0.07 % for the high dose) at 72 h post-dose. It has demonstrated that MCPA does not trend to be stored or accumulated in tissues. Total radioactivity in body was calculated to be approximately 101% AA and below 0.6% AA was found in carcass at the end of experiments for both doses.
- Details on excretion:
- Results achieved that MCPA is efficiently absorbed and also eliminated. Renal excretion of parent compound and metabolites was a major elimination route. More than 90% of the initial dose was eliminated by urine during 24 h at low dose and 48 h at high dose.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Remarks:
- HMCPA
- Details on metabolites:
- MCPA circulated in blood as unchanged form (RT=6.9 min). It was excreted by urine mainly as parent compound and two metabolites; its 2-hydroxy derivative HMCPA with RT=2.6 mm and unidentified metabolite with RT=6 min.
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.
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.