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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:
- 8.3 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
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