Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.7 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:
subchronic to chronic
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:
The toxicological relevance of the rat findings (microscopic changes in the nasal cavities) to humans is limited owing to the morphological and physiological differences of the nasal and olfactory epithelia between rats and humans which support a higher sensitivity of humans compared to rodents (see Endpoint summary: Repeated dose toxicity, for details). According to ECETOC report, a factor of 1 is thus considered to be adequate to extrapolate to human, particularly for water soluble substance as Dimethyl 2 methylglutarate is).
AF for intraspecies differences:
3
Justification:
according to the ECETOC report, a factor of 3 is considered to be adequate for workers, particularly in the case of a local effect.
AF for the quality of the whole database:
1
Justification:
GLP and OECD compliant study
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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:
subchronic to chronic
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:
The toxicological relevance of the rat findings (microscopic changes in the nasal cavities) to humans is limited owing to the morphological and physiological differences of the nasal and olfactory epithelia between rats and humans which support a higher sensitivity of humans compared to rodents (see Endpoint summary: Repeated dose toxicity, for details). According to ECETOC report, a factor of 1 is thus considered to be adequate to extrapolate to human, particularly for water soluble substance as Dimethyl 2 methylglutarate is.
AF for intraspecies differences:
5
Justification:
according to the ECETOC report, a factor of 5 is considered to be adequate for general population, particularly in the case of a local effect.
AF for the quality of the whole database:
1
Justification:
GLP and OECD compliant study
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population