Registration Dossier
Registration Dossier
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EC number: 255-449-7 | CAS number: 41583-09-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.9 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 111.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No adjustment is made for oral /inhalation absorption. The oral route is considered the most favourable one for uptake because melaminephosphate disintegrates to melamine and phosphate in stomach acid.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study available.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in route-to-rout extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.26 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The oral route is considered to be the worst case in regard to systemic uptake as the poorly soluble substance becomes dissolved in the acid environment of the stomach acid.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study with rats
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- no hazard identified
Additional information - workers
The available testing data on melamine, phosphates and melamine phosphate show that repeated-dose systemic toxicity is the most sensitive endpoint. The formation of bladder stones by melamine was used to calculate the DNEL. The calculated DNEL is lower than the general exposure limit of inhalable dust of 10 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.18 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 54.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
See worker
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 0.63 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 0.63 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
The hazard assessment is based on experimental data on melamine. Therefore it needs to be mentioneed that various national and international agencies are currently reviewing the acceptable levels of melamine in food. The levels are lower than the calculated oral DNEL as co-exposure to substances that form poorly soluble precipitates with melamine is being evaluated.
The intended use of melamine melamine phosphate as a flame retardent does not result in oral exposure.
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