Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.6 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
132.23 mg/m³
Explanation for the modification of the dose descriptor starting point:

Corrected inhalatory NOAEC for workers = 150 mg/kg bw/day* 0.5 * (1 / 0.38 m³/kg bw/day) * (6.7 m³/10 m³) = 132.23 mg/m³

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
4
Justification:
As the NOAEL of a repeated dose toxicity study (OECD 422) with an exposure time of approx. 50 days (males: 50 days; females: 2 weeks prior to mating until Postpartum Day 13) was used as point of departure an AF of 4 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
Included in route-to-route extrapolation.
AF for other interspecies differences:
2.5
Justification:
ECHA REACH standard AF for "differences not related to calorimetric differences"
AF for intraspecies differences:
5
Justification:
Default value according to R.8.4.3.1
AF for the quality of the whole database:
1
Justification:
No issues with the quality of the data base
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No specific information on dermal absorption taken into account. This approach starts from the assumption that dermal absorption will not be higher than oral absorption. The default assessment factor of 1 for oral to dermal route-to-route extrapolation is taken into account.

AF for dose response relationship:
1
Justification:
Not required as starting point is NOAEL
AF for differences in duration of exposure:
4
Justification:
As the NOAEL of a repeated dose toxicity study (OECD 422) with an exposure time of approx. 50 days (males: 50 days; females: 2 weeks prior to mating until Postpartum Day 13) was used as point of departure an AF of 4 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH standard AF for rat to human extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA REACH standard AF for "differences not related to calorimetric differences"
AF for intraspecies differences:
5
Justification:
ECHA REACH standard AF for intraspecies differences to workers
AF for the quality of the whole database:
1
Justification:
No issues with the quality of the data base
AF for remaining uncertainties:
1
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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.62 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
62.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

Corrected inhalatory NOAEC for general population = 150 mg/kg bw/day* 0.5 * (1 / 1.15 m³/kg bw/day) = 65.2 mg/m³

AF for dose response relationship:
1
Justification:
Not required as starting point is NOAEL
AF for differences in duration of exposure:
4
Justification:
As the NOAEL of a repeated dose toxicity study (OECD 422) with an exposure time of approx. 50 days (males: 50 days; females: 2 weeks prior to mating until Postpartum Day 13) was used as point of departure an AF of 4 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
Included in route-to-route extrapolation.
AF for other interspecies differences:
2.5
Justification:
Differences not related to calorimetric differences
AF for intraspecies differences:
10
Justification:
Default value according to R.8.4.3.1
AF for the quality of the whole database:
1
Justification:
No issues with the quality of the data base
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.375 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No specific information on dermal absorption taken into account. This approach starts from the assumption that dermal absorption will not be higher than oral absorption. The default assessment factor of 1 for oral to dermal route-to-route extrapolation is taken into account.

AF for dose response relationship:
1
Justification:
Not required as starting point is NOAEL
AF for differences in duration of exposure:
4
Justification:
As the NOAEL of a repeated dose toxicity study (OECD 422) with an exposure time of approx. 50 days (males: 50 days; females: 2 weeks prior to mating until Postpartum Day 13) was used as point of departure an AF of 4 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH standard AF for rat to human extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA REACH standard AF for "differences not related to calorimetric differences"
AF for intraspecies differences:
10
Justification:
ECHA REACH default AF for the general population
AF for the quality of the whole database:
1
Justification:
No issues with the quality of the data base
AF for remaining uncertainties:
1
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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
0.375 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral absorption by rat and human are assumed to be equal.

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
4
Justification:
As the NOAEL of a repeated dose toxicity study (OECD 422) with an exposure time of approx. 50 days (males: 50 days; females: 2 weeks prior to mating until Postpartum Day 13) was used as point of departure an AF of 4 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH standard AF for rat to human extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA REACH standard AF for "differences not related to calorimetric differences"
AF for intraspecies differences:
10
Justification:
ECHA REACH standard AF for the general population
AF for the quality of the whole database:
1
Justification:
No issues with the quality of the data base
AF for remaining uncertainties:
1
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:
no hazard identified

Additional information - General Population