Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.145 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
LOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.292 mg/m³
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEC

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.042 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.083 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEL

Workers - Hazard for the eyes

Additional information - workers

The following figures were used to determine the long-term and short-term DNEL's for workers:

Short-term:

The DNEL's were derived from a repeated dose toxicity study, where an LOAEL was determined. Based on this, an assessment factor of 3 was applied, in accordance with ECETOC guidance.

Intraspecies (allometric) assessment factor: 4, (rat as test species)

Intraspecies (additional) assessment factor: 2.5,

Interspecies assessment factor: 5,

Duration assessment factor: 1, (90 day study)

Dose-Response assessment factor: 3 (derived from an LOAEL according to ECETOC guidance),

Database quality assessment factor: 2 (possible concerns over reprotoxicity).

Overall Assessment Factor: 300

Long-term:

The DNEL's were derived from a repeated dose toxicity study, where an LOAEL was determined. Based on this, an assessment factor of 3 was applied, in accordance with ECETOC guidance.

Intraspecies (allometric) assessment factor: 4, (rat as test species)

Intraspecies (additional) assessment factor: 2.5,

Interspecies assessment factor: 5,

Duration assessment factor: 2, (90 day study)

Dose-Response assessment factor: 3 (derived from an LOAEL according to ECETOC guidance),

Database quality assessment factor: 2 (possible concerns over reprotoxicity).

Overall assessment factor: 600

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

DNEL derivation is not required for the general population - there are no uses proposed for glycidol that would result in general population exposure. In addition the strictures placed upon the material arising from its toxic and CMR classification would preclude use by the general population.