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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.05 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):
25
Dose descriptor starting point:
NOAEC
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

A 90-day repeated dose oral gavage study in rats was used to derive the long-term DNEL for systemic effects via inhalation. The starting NOAEL was established at 100 mg/kg bw/day. The corrected NOAEC is 100/0.38 m³/kg bw × (6.7 m³/10 m³) = 176.3 mg/m³/day

AF for dose response relationship:
1
Justification:
No evidence occurred that would justify to change the default assessment factor. Therefore, no additional factor us needed.
AF for differences in duration of exposure:
2
Justification:
The default extrapolation factor for exposure duration is used. Starting point: sub-chronic, to end point: chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
No additional factor is required.
AF for other interspecies differences:
2.5
Justification:
The default value for interspecies (remaining differences) is used.
AF for intraspecies differences:
5
Justification:
The default value for workers is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole database is considered to be sufficient and uncritical. No issues related to completeness and consistency of the available data occurred. Therefore, no additional factor is needed.
AF for remaining uncertainties:
1
Justification:
The assessment factors used are considered to be sufficiently conservative. Therefore, no additional factor is required.
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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):
100
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In a 90-day repeated dose oral gavage study in rats, the starting NOAEL was established at 100 mg/kg bw/day. Assuming 100% absorption via oral and 10% via dermal, the corrected NOAEL is 100 × (100/10) = 1000 mg/kg bw/day (See justification in 7.2.3 Acute Tox, Dermal Waiver; under 'Remark").

AF for dose response relationship:
1
Justification:
No evidence occured that would justify to change the default assesment factor. Therefore, no additional factor is required.
AF for differences in duration of exposure:
2
Justification:
The default extrapolation factor for exposure duration is used. Starting point: sub-chronic, to end point: chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
2.5
Justification:
The default value for interspecies (remaining differences) is used.
AF for intraspecies differences:
5
Justification:
The default value for workers is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole database is considered to be sufficient and uncritical. No issues related to completeness and consistency of the available data occured. Therefore, no additional factor is required.
AF for remaining uncertainties:
1
Justification:
The assessment factors used are considered to be sufficiently conservative. Therefore, no additional factor is required.
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:
medium hazard (no threshold derived)

Additional information - workers

No DNELs for acute systemic or local effects were derived. Long-term DNELs in combination with suitable safety measures for processing/packaging with regards to classification as severe eye irritant are considered sufficient to ensure that exposure will not occur at the work place.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.74 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
86.96 mg/m³
Explanation for the modification of the dose descriptor starting point:

A 90-day repeated dose oral gavage study in rats was selected for the derivation of the long-term DNEL for systemic effects via inhalation. The starting NOAEL was established at 100 mg/kg/day. The corrected NOAEC is 100 / 1.15 m³/kg bw = 86.96 mg/m³.

AF for dose response relationship:
1
Justification:
No evidence occured that would justify to change the default assesment factor. Therefore, no additional factor is required.
AF for differences in duration of exposure:
2
Justification:
The default extrapolation factor for exposure duration is used. Starting point: sub-chronic, to end point: chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
No additional factor is required.
AF for other interspecies differences:
2.5
Justification:
The default value for interspecies (remaining differences) is used.
AF for intraspecies differences:
10
Justification:
The default value for the general population is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole database is considered to be sufficient and uncritical. No issues related to completeness and consistency of the available data occured. Therefore, no additional factor is required.
AF for remaining uncertainties:
1
Justification:
The assessment factors used are considered to be sufficiently conservative. Therefore, no additional factor is required.
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25 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):
200
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In a 90-day repeated dose oral gavage study in rats , the starting NOAEL was established at 100 mg/kg bw/day. Assuming 100 % absorption via oral and 10 % via dermal, the corrected NOAEL is 100 × (100/10) = 1000 mg/kg bw/day (See justification in 7.2.3 Acute Tox, Dermal Waiver; under 'Remark").

AF for dose response relationship:
1
Justification:
No evidence occured that would justify to change the default assesment factor. Therefore, no additional factor is needed.
AF for differences in duration of exposure:
2
Justification:
The default extrapolation factor for exposure duration is used. Starting point: sub-chronic, to end point: chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
2.5
Justification:
The default value for interspecies (remaining differences) is used.
AF for intraspecies differences:
10
Justification:
The default value for the general population is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole database is considered to be sufficient and uncritical. No issues related to completeness and consistency of the available data occured. Therefore, no additional factor is needed.
AF for remaining uncertainties:
1
Justification:
The assessment factors used are considered to be sufficiently conservative. Therefore, no additional factor is required.
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
DNEL related information
Justification:
.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population