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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
11.8 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):
75
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

Most sensitive endpoint: the NOAEL for a combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test was considered to be 1000 mg/kg/day for males and females.

The NOAEL for reproductive/developmental toxicity was considered to be 1000 mg/kg/bw.

--> correct to worker, 8h inhalation:

NOAEC = 1000 * (1/ 0.38) * (6.7 / 10) = 1763.2 mg/m3

--> in the absence of information on gastro-intestinal absorption an assessment factor of 2, default value for oral-to-inhalation extrapolation has to be applied:

NOAEC = 1763.2 / 2 = 881.6 mg/m3

AF for dose response relationship:
1
Justification:
No assessment factor required
AF for differences in duration of exposure:
6
Justification:
ECHA REACH standard AF for sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Not used for oral results
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 additional assessment factor required, sufficient data of good quality available
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
3.4 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 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:

Most sensitive endpoint: the NOAEL for a combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test was considered to be 1000 mg/kg/day for males and females.

The NOAEL for reproductive/developmental toxicity was considered to be 1000 mg/kg/bw.

Modification of dose descriptor based on route-to-route extrapolation:

corr. NOAEL = NOAEL (mg/kg bw/d) * Abs (oral, rat) / Abs (dermal, human)

with:

- Abs (oral, rat) = 50% and

- Abs (dermal, human) = 50% according to ECHA's Guidance on Information Requirements and

Chemical Safety Assessment, Section R7c.12.2.4.

corr. NOAEL = 1000*50/50 = 1000 mg/kg bw/d

AF for dose response relationship:
1
Justification:
No assessment factor required
AF for differences in duration of exposure:
6
Justification:
ECHA REACH standard AF for sub-acute to chronic 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:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 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):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
434.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

Most sensitive endpoint: the NOAEL for a combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test was considered to be 1000 mg/kg/day for males and females.

The NOAEL for reproductive/developmental toxicity was considered to be 1000 mg/kg/bw for pubs.

--> correct to general population, 24h inhalation:

NOAEC = NOAEL (mg/kg bw/d) * (1/1.15 m3/kg bw)

NOAEC = 1000 * (1/1.15) = 869.6 mg/m3

--> in the absence of information on gastro-intestinal absorption an assessment factor of 2, default value for oral-to-inhalation extrapolation has to be applied:

NOAEC = 869.6 / 2 = 434.8 mg/m3

AF for dose response relationship:
1
Justification:
No assessment factor required
AF for differences in duration of exposure:
6
Justification:
ECHA REACH standard AF for sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Not used for oral results
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 additional assessment factor required, sufficient data of good quality available.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
1.7 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 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:

Modification of dose descriptor based on route-to-route extrapolation:

corr. NOAEL = NOAEL (mg/kg bw/d) * Abs (oral, rat) / Abs (dermal, human)

with:

- Abs (oral, rat) = 50% and

- Abs (dermal, human) = 50% according to ECHA's Guidance on Information Requirements and

Chemical Safety Assessment, Section R7c.12.2.4.

corr. NOAEL = 1000*50/50 = 1000 mg/kg bw/d

AF for dose response relationship:
1
Justification:
No assessment factor required
AF for differences in duration of exposure:
6
Justification:
ECHA REACH standard AF for sub-acute to chronic 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 additional assessment factor required, sufficient data of good quality available
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 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:

No modification ot the dose descriptor required

AF for dose response relationship:
1
Justification:
No assessment factor required
AF for differences in duration of exposure:
6
Justification:
ECHA REACH standard AF for sub-acute to chronic 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 additional assessment factor required, sufficient data of good quality available
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population