Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.93 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):
250
Modified dose descriptor starting point:
NOAEC
Value:
233 mg/m³
Explanation for the modification of the dose descriptor starting point:

See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.

The formula for the calculation of the modified dose descriptor starting point is:

NOAEC = oral NOEL x 1/0.38 x 1/2 x 6.7/10 = 264 x 1/0.38 x 1/2 x 6.7/10 = 233 mg/m3

AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.06 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):
250
Modified dose descriptor starting point:
NOAEL
Value:
264 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.

NOEL (oral) = NOEL (dermal)

AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The long-term DNELs (systemic effects) for workers are:

dermal 1.06 mg/kg/day

inhalation 0.93 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.23 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):
500
Modified dose descriptor starting point:
NOAEC
Value:
115 mg/m³
Explanation for the modification of the dose descriptor starting point:

See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.

The formula for the modified dose descriptor starting point NOAEC is as follows:

NOAEC = NOEL (oral)x 1/1.15 x 1/2 = 264 x 1/1.15 x 1/2 = 115 mg/m3

AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
consumers
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.53 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):
500
Modified dose descriptor starting point:
NOAEL
Value:
264 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.

Oral = dermal

AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
consumers
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
low 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:
0.53 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):
500
Dose descriptor starting point:
NOAEL
Value:
264 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
consumers
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The long-term DNELs (systemic effects) for the general population are

DNEL oral                     0.53 mg/kg/day

DNEL dermal                 0.53 mg/kg/day

DNEL inhalation              0.23 mg/m3