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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14.8 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):
50
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
739.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point is the NOAEL from the OECD 422 of 300 mg/kgbw/d based on clinical signs observed in the high dose group.

The corrected 8 hr inhalation NOAEC for workers is NOAEL (300) * 1.76 *1.4* mg/m3 = 739.2 mg/m3.

- 1.76 : correction for differences in respiratory volume (workers) 

- 1.4 : for 7/5 correction for differences between human and experimental exposure condition (workers)

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL.
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use a factor of 6, and a factor of 2 for a 90-day study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
5
Justification:
Assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
reliable data.
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:
4.2 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
840 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a combined repeated dose toxicity study with the reproduction/developmental toxicity study by oral administration to rats (Salvador, 2019). The starting dose for DNEL calculation was a NOAEL of 300 mg/kg/day. Default absorption rates of 100 and 50% are assumed for the oral and dermal routes, respectively. The NOAEL (8h) derived for workers is :

300 x 2 x 1.4 = 840 mg/kg/day

- 2 : for 100/50. Default absorption rates of 100 and 50% are assumed for the oral and dermal routes, respectively

- 1.4 : correction for differences between human and experimental exposure condition (workers).

AF for dose response relationship:
1
Justification:
Default assessment (DNEL calculator). No specific concerns; starting point is NOAEL
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use a factor of 6, and a factor of 2 for a 90-day study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator). Allometric scalling for oral to dermal.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
5
Justification:
Assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
Reliable data
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
DNEL (Derived No Effect Level)
Value:
0.75 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):
400
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point is the NOAEL from the OECD 422 of 300 mg/kgbw/day based on clinical signs observed in the high dose group. No correction factor should have to be applied.

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL.
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use a factor of 6, and a factor of 2 for a 90-day study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
4
Justification:
A defeult factor for allometric scaling is 4 for rat to human.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is applied for remaining differences
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
No additional factor.
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