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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.93 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
292.775 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation is not the preferred route for absorption. Original value is NOAEL 239 mg/kg bw/day from reproductive/developmental toxicity study on rat by oral administration performed on similar substance and recalculated on target substance (for details regarding read-across justification and derivation of NOAEL see attached document in section 13 of this IUCLID dossier ). Allometric scaling from rat to human is 4. The result is multiplied by 70 kg considered as the average weight of a human being (bw) and divided by 10 m^3/person considered as the average volume that is breathed in a 8h exposure. Conclusion [(239 mg/kg bw/d / 4)*70 kg bw]/10 m^3/person= 418.25 mg/m^3. This value should be multiply by 0.5 (considering the oral absorption 50% in oral-to-inhalation extrapolation) and by 1.4 (considering the correction for differences between human and experimental exposure conditions, i.e. 7 days per week (experimental)/ 5 days per week (worker population)). NAEC is 292.775 mg/ m^3.

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
1
Justification:
Already considered in NOAEC calculation (Appendix R 8.2).
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
5
Justification:
Default value proposed in ECHA R.8 Guidance for worker (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability
AF for remaining uncertainties:
1
Justification:
No further uncertainties.
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:
1.12 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
other: NOAEL ( 239 mg/ kg bw/day) modified considering the differences between human and experimental exposure conditions.
Value:
334.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Original value NOAEL 239 mg/kg bw/day (from reproduction/developmental toxicity study on rats for a similar substance recalculated on target substance- for details regarding read-across justification and derivation of NOAEL see attached document in section 13 of this IUCLID dossier ) was multiplied by 1.4 (considering the correction for differences between human and experimental exposure conditions, i.e. 7 days per week (experimental)/ 5 days per week (worker population)). Starting point = 239 mg/ kg bw/day * 1.4 = 334.6 mg/ kg bw/day

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
4
Justification:
Default value proposed in ECHA R.8 guidance ( table R 8.3)
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
5
Justification:
Default value proposed in ECHA R.8 Guidance for worker (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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

Tris(ethyl acetoacetato-O1',O3)aluminium is classified H317 (skin sens. cat.1) and H319 (eye irr.cat.2) according to the CLP Regulation (EC n.1272/2008).

The assessment is done based on reproduction/developmental toxicity study on rats by oral route for a similar substance. The NOAEL from this study was modified considering the structure and the molecular weight of Tris(ethyl acetoacetato-O1',O3)aluminium and NOAEL obtained for target substance = 239 mg/kg bw/day (for details regarding read-across justification and derivation of NOAEL see attached document in section 13 of this IUCLID dossier )

 

The values of DNEL calculated for workers are:

 

INHALATION ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL= 3.93 mg/m^3 (NAEC= 292.775 mg/m^3 and Overall AF= 75)

b) SHORT TERM: No hazard identified

LOCAL EFFECTS: Low hazard identified for LONG and SHORT TERM exposure based on its potential to be irritant for mucous membrane of nasopharyngeal region.

 

DERMAL ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL = 1.12 mg/kg bw/day (Starting point: 239 mg/kg bw/day (NOAEL for target substance) *1.4 = 334.6 mg/kg bw/day and Overall AF= 300)

b) SHORT TERM: High hazard identified due to classification H317 (skin sens. cat.1)

LOCAL EFFECTS: No hazard identified for LONG AND SHORT TERM based on the substance is not skin irritant and there is no reason of concern for acute dermal toxicity.

HAZARD FOR EYE:LOCAL EFFECTS: Low hazard identified based on the substance is classified irritant to the eyes (H319).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.59 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Value:
89.625 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation is not the preferred route for absorption. Original value is NOAEL 239 mg/kg bw/day from reproductive/developmental toxicity study on rat by oral administration performed on similar substance and recalculated on target substance (for details regarding read-across justification and derivation of NOAEL see attached document in section 13 of this IUCLID dossier ). Allometric scaling from rat to human is 4. The result is multiplied by 60 kg considered as the average weight of a human being (bw) and divided by 20m^3/person considered as the average volume that is breathed by general population . Conclusion [(239 mg/kg bw/d / 4)*60 kg bw]/20 m^3/person= 179.25 mg/m^3. This value should be multiply by 0.5 (considering the oral absorption 50% in oral-to-inhalation extrapolation). NAEC is 89.625 mg/ m^3.

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6)
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6)
AF for interspecies differences (allometric scaling):
1
Justification:
Already considered in NOAEC calculation (Appendix R8.2)
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6)
AF for intraspecies differences:
10
Justification:
Default value proposed in ECHA R.8 Guidance for general population (table R 8.6)
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties.
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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.398 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
239 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL = 239 mg/kg bw/day derives from reproduction/developmental toxicity study on rats by oral route for a similar substance recalculated on target substance (for details regarding read-across justification and derivation of NOAEL see attached document in section 13 of this IUCLID dossier ).

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
4
Justification:
Default value proposed in ECHA R.8 guidance ( table R 8.3)
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
10
Justification:
Default value proposed in ECHA R.8 Guidance for general population (table R 8.6).
AF for the quality of the whole database:
1
Justification:
No further uncertainties.
AF for remaining uncertainties:
1
Justification:
No further uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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:
0.398 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
239 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation. NOAEL = 239 mg/kg bw/day derives from reproduction/developmental toxicity study on rats by oral route for a similar substance recalculated on target substance (for details regarding read-across justification and derivation of NOAEL see attached document in section 13 of this IUCLID dossier ).

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
4
Justification:
Default value proposed in ECHA R.8 guidance ( table R 8.3).
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
10
Justification:
Default value proposed in ECHA R.8 Guidance for general population (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Tris(ethyl acetoacetato-O1',O3)aluminium is classified H317 (skin sens. cat.1) and H319 (eye irr.cat.2) according to the CLP Regulation (EC n.1272/2008).

 The assessment is done based on reproduction/developmental toxicity study on rats by oral route for a similar substance. The NOAEL from this study was modified considering the structure and the molecular weight of Tris(ethyl acetoacetato-O1',O3)aluminium and NOAEL obtained for target substance = 239 mg/kg bw/day (for details regarding read-across justification and derivation of NOAEL see attached document in section 13 of this IUCLID dossier )

The values of DNEL calculated for general population are:

 

INHALATION ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL= 0.59 mg/m^3 (NAEC= 89.625 mg/m^3 and Overall AF= 150)

b) SHORT TERM: No hazard identified

LOCAL EFFECTS: Low hazard identified for LONG AND SHORT TERM based its potential to be irritant for mucous membrane of nasopharyngeal region

 

DERMAL ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL = 0.398 mg/kg bw day (Starting point NOAEL for target substance= 239 mg/kg bw/day and Overall AF= 600)

b) SHORT TERM: High hazard identified due to classification H317 (skin sens. cat.1)

LOCAL EFFECTS: No hazard identified for LONG AND SHORT TERM based on the substance is not skin irritant and there is no reason of concern for acute dermal toxicity. 

ORAL ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL = 0.398 mg/kg bw/day (NOAEL for target substance= 239 mg/kg bw/day and Overall AF= 600)

b) SHORT TERM: : No hazard identified based on the substance is not classified for acute oral toxicity

 

HAZARD FOR EYE:LOCAL EFFECTS: Low hazard identified based on the substance has been classified irritant to the eyes.