Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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