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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.19 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):
75
Modified dose descriptor starting point:
LOAEC
Value:
238.91 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation is applied in accordance with the ECHA REACH Guidance on Information Requirements R8 by dividing by the 8-hr respiratory volume of the rat (0.38 m³/kg bw), and corrected for light activity of the worker (6.7 m³/ 10 m³). The derived concentration is corrected for differences in oral and inhalation absorption with a default factor of 2, in accordance with the ECHA REACH Guidance, arriving at a LAEC worker of 238.91 mg/m³.

AF for dose response relationship:
1
Justification:
Default factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
DNEL is derived from a subacute study
Justification:
Allometric scaling is included in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Default factor for intraspecies differences worker
AF for the quality of the whole database:
1
Justification:
DNEL derived from a reliable OECD422 study
Justification:
No remaining uncertainties 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:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 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
Modified dose descriptor starting point:
NOAEL
Value:
271 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation is applied in accordance with the ECHA REACH Guidance on Information Requirements R8. Based on the toxicokinetic assessment it is assumed that dermal absorption is similar to oral absorption and therefore no additional assessment factor had to be applied.

AF for dose response relationship:
1
Justification:
Default factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
DNEL is derived from a subacute study
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor for rat
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Default factor for intraspecies difference worker
AF for the quality of the whole database:
1
Justification:
DNEL derived from a reliable OECD422 study
Justification:
No remaining uncertainties 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:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.79 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):
150
Modified dose descriptor starting point:
LOAEC
Value:
117.83 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation is applied by dividing by the 24-hr respiratory volume of the rat (1.15 m³/kg bw). The derived concentration is corrected for differences in oral and inhalation absorption with a default factor of 2, in accordance with the ECHA REACH Guidance, arriving at a LAECgeneral public of 117.83 mg/m³.

AF for dose response relationship:
1
Justification:
Default factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
DNEL is derived from a subacute study
Justification:
Allometric scaling is included in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Default factor for intraspecies difference general public
AF for the quality of the whole database:
1
Justification:
DNEL derived from a reliable OECD422 study
Justification:
No remaining uncertainties 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:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.45 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
271 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation is applied in accordance with the ECHA REACH Guidance on Information Requirements R8. Based on the toxicokinetic assessment it is assumed that dermal absorption is similar to oral absorption and therefore no additional assessment factor had to be applied,

AF for dose response relationship:
1
Justification:
Default factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
DNEL is derived from a subacute study
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor for rat
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Default factor for intraspecies difference general public
AF for the quality of the whole database:
1
Justification:
DNEL derived from a reliable OECD422 study
Justification:
No remaining uncertainties 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:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.45 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
271 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
Default factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
DNEL is derived from a subacute study
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor for rat
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Default factor for intraspecies difference general public
AF for the quality of the whole database:
1
Justification:
DNEL derived from a reliable OECD422 study
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

For systemic effects, DNELs were derived for inhalation, dermal and oral exposure using the oral OECD422 study in which a NOAEL of 271 mg/kg bw/d was obtained based on increased liver weights and increased centrilobular hepatocyte hypertrophy in males and females at the highest dose level.

No DNELs were derived for local effects, however, based on its CLP classification of eye damaging (H318) and skin irritation (H315), Diacid 1550 should be regarded as a medium hazard in accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Part E Risk Characterisation.