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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-449-7 | CAS number: 41583-09-9
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor starting point:
- LOAEL
- Value:
- 126 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 310.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Melamine is absorbed rapidly and almost completely after oral dosing and there is apparently no metabolism in rats. A similar toxicokinetic profile is expected for melamine phosphate. A transformation of the LOAEL oral to LOAEC inhalation is therefore justified, taking the default absorption rate for inhalation of 100 %, and setting also the oral absorption rate to 100 %.
The LOAEC rat, inhalation calculated from the LOAEL oral, 2 years of 126 mg/kg bw/d (carcinogenicity study) and the standard respiratory volume sRV for the rat of 0.38 m³/kg bw for an 8 hour exposure.
The LOAEC was further adjusted for an increased respiratory volume of 10 m³/8h for workers, compared to 6.7 m³/8h for the general public.
The exposure conditions for the orally dosed rats were 7d/w compared to the inhalation exposure of workers of 5d/w.
126 x 1 x 2.63 x 0.67 x 1.4 = 310.8 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- LOAEL as a starting point and a steep dose-response curve
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for a chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling already applied via modification of the starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for the worker
- AF for the quality of the whole database:
- 1
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
- AF for remaining uncertainties:
- 1
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- LOAEL
- Value:
- 126 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 1 764 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal absorption is estimated to be 10 % as a worst-case assumption. The LOAEL of the original study has further been modified to account for the differences in exposure duration (7d/week for oral rat dosing vs. 5d/week for the worker).
- AF for dose response relationship:
- 3
- Justification:
- LOAEL as a starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for a rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default for the worker
- AF for the quality of the whole database:
- 1
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
- AF for remaining uncertainties:
- 1
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 126 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 1 260 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
LOAEC has been corrected to account for dermal absorption (10% assumed as a worst case approach).
- AF for dose response relationship:
- 3
- Justification:
- Default factor for LOAEC as starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
- AF for remaining uncertainties:
- 1
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 126 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- Default for LOAEL as a starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
- Justification:
- several studies for melamine in several species available. No factor for read-across needed, as the toxicologically relevant compound is melamine; using a melamine study as a starting point is a worst-case approach for melamine phosphate.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.