Registration Dossier

Administrative data

Workers - 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:
DNEL (Derived No Effect Level)
Value:
8.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
6
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
use of a NOAEC as a starting point
AF for differences in duration of exposure:
2
Justification:
due to the starting point coming from a 90-day study and the lack of information about how duration of exposure affects the NOEC, a factor of 2 is justified to extrapolate from sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric scaling is applied because local effects are considered.
AF for other interspecies differences:
1
Justification:
critical effect is local tissue damage due to irritation caused by the pH of the material after it hydrolyses locally inthe upper respiratory tract. This effect is unlikely to be influenced by 'other differences' between rats and humans
AF for intraspecies differences:
3
Justification:
according to ECETOC report and a more recent report by the BfR a factor of 3 is considered to be adequate, particularly in the case of a local effect
AF for the quality of the whole database:
1
Justification:
data are obtained with dimethyl glutarate, the main component of dibasic esters blend, but no differences are expected between all 3 components in terms of local effects, when comparing the results of both 90-day inhalation studies provided, using either the dibasic ester blend or each individual component
AF for remaining uncertainties:
1
Justification:
not applicable
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:
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

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:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
use of a NOAEC as a starting point
AF for differences in duration of exposure:
2
Justification:
due to the starting point coming from a 90-day study and the lack of information about how duration of exposure affects the NOEC, a factor of 2 is justified to extrapolate from sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric scaling is applied because local effects are considered
AF for other interspecies differences:
1
Justification:
critical effect is local tissue damage due to irritation caused by the pH of the material after it hydrolyses locally inthe upper respiratory tract. This effect is unlikely to be influenced by 'other differences' between rats and humans
AF for intraspecies differences:
5
Justification:
according to ECETOC report and a more recent report by the BfR a factor of 5 is considered to be adequate, particularly in the case of a local effect
AF for the quality of the whole database:
1
Justification:
data are obtained with dimethyl glutarate, the main component of dibasic esters blend, but no differences are expected between all 3 components in terms of local effects, when comparing the results of both 90-day inhalation studies provided, using either the dibasic ester blend or each individual component
AF for remaining uncertainties:
1
Justification:
not applicable
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:
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

General Population - Hazard via oral 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population