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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
37 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:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
925 mg/m³
Explanation for the modification of the dose descriptor starting point:

Basis for the calculation of the corrected inhalatory No-Observed-Adverse-Effect-Concentration (NOAEC) is a No-Observed-Adverse-Effect-Level (NOAEL) of 500 mg/kg bw/day as determined in a subchronic (90-day) oral repeated dose toxicity study in the rat. Corrections for differences in respiratory volumes of laboratory animals and workers (1/0.38), for the respiratory volume in light activity (6.7/10), for the frequency of exposure (7/5) as well as for inhalative and oral bioavailability (0.75) were accounted for.

Corrected inhalatory NOAEC = NOAELoral, rat x (1/sRVrat) x (sRVhuman/wRV) x (ABSoral, rat/ABSinhal., human) x (fexpo, rat/fexpo, worker)

sRV: Standard respiratory volume

wRV: Respiratory volume of workers (8 h)

ABS: Absorption rate (oral absorption is assumed to be 75% of inhalation absorption as default)

fexpo: Frequency of exposure (rat: 7 days/week; workers: 5 days/week)

Corrected inhalatory NOAEC = 500 x (1/0.38) (6.7/10) x 0.75 x (7/5) = 926 mg/m3

AF for dose response relationship:
1
Justification:
Starting point is NOAEL or NOAEC. Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation. Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Not relevant for inhalatory exposure as already considered in species-specific respiratory volumes. Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
High quality study used to calculate DNEL. Default (DNEL calculator)
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:
263 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:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
26 250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Basis for the calculation of the corrected dermal No-Observed-Adverse-Effect-Level (NOAEL) is a NOAEL of 500 mg/kg bw/day as determined in a subchronic (90-day) oral repeated dose toxicity study in the rat. Corrections for dermal and oral bioavailability (37.5) and differences in the frequency of exposure (7/5) were accounted for.

Corrected dermal NOAEL = NOAELoral, rat x (ABSoral, rat/ABSdermal, human) x (fexpo, rat/fexpo, worker)

ABS: Absorption rate

fexpo: Frequency of exposure (rat: 7 days/week; workers: 5 days/week)

Corrected dermal NOAEL = 500 x 37.5 x (7/5) = 26250 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Starting point is NOAEL or NOAEC. Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation. Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default for rat. Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
ECHA default for workers. Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
High quality study used to calculate DNEL. Default (DNEL calculator)
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

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:
6.53 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:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
326 mg/m³
Explanation for the modification of the dose descriptor starting point:

Basis for the calculation of the corrected inhalatory No-Observed-Adverse-Effect-Concentration (NOAEC) is a No-Observed-Adverse-Effect-Level (NOAEL) of 500 mg/kg bw/day as determined in a subchronic (90-day) oral repeated dose toxicity study in the rat. Corrections for differences in respiratory volumes of laboratory animals and the general population (1/1.15) and for inhalative and oral bioavailability (0.75) were accounted for.

Corrected inhalatory NOAEC = NOAELoral, rat x (1/sRVrat) x (ABSoral, rat/ABSinhal., human)

sRV: Standard respiratory volume

ABS: Absorption rate (oral absorption is assumed to be 75% of inhalation absorption as default)

Corrected inhalatory NOAEC = 500 x (1/1.15) x 0.75 = 326 mg/m3

AF for dose response relationship:
1
Justification:
Starting point is NOAEL or NOAEC. Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation. Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Not relevant for inhalatory exposure as already considered in species-specific respiratory volumes. Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
ECHA default for general population. Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
High quality study used to calculate DNEL. Default (DNEL calculator)
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:
93.8 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:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
18 750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Basis for the calculation of the corrected dermal No-Observed-Adverse-Effect-Level (NOAEL) is a NOAEL of 500 mg/kg bw/day as determined in a subchronic (90-day) oral repeated dose toxicity study in the rat. A correction for dermal and oral bioavailability (37.5) was accounted for.

Corrected dermal NOAEL = NOAELoral, rat x (ABSoral, rat/ABSdermal, human)

ABS: Absorption rate

Corrected dermal NOAEL = 500 x 37.5 = 18750 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Starting point is NOAEL or NOAEC. Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation. Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default for rat. Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
ECHA default for general population. Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
High quality study used to calculate DNEL. Default (DNEL calculator)
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 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:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation is required as the oral long-term DNEL for systemic effects is based on a No-Observed-Adverse-Effect-Level (NOAEL) of 500 mg/kg bw/day as determined in a subchronic (90-day) oral repeated dose toxicity study in the rat.

AF for dose response relationship:
1
Justification:
Starting point is NOAEL or NOAEC. Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation. Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default for rat. Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
ECHA default for general population. Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
High quality study used to calculate DNEL. Default (DNEL calculator)
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:
no hazard identified

Additional information - General Population