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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14.31 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:
870 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 073 mg/m³
Explanation for the modification of the dose descriptor starting point:

A systemic NOAEL of 870 mg/kg bw /day was determined for the substance in an oral sub-acute Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in rats (OECD 422, GLP). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (a default factor of 2 is included (*0.5); in accordance with ECHA Guidance R.8 the absorption rate of the starting route is half that of the end route), the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.

NOAEC corrected = 870 mg/kg bw/day * 1/0.38 m³/kg/day * 50/100 * (6.7 m³/10 m³) * 1.4 = 1073 mg/m³

AF for dose response relationship:
1
Justification:
Assessment factor for dose response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOAEC
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factors for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are 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:
4.06 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:
870 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 218 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic NOAEL of 870 mg/kg bw /day was determined for the substance in an oral sub-acute Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in rats (OECD 422, GLP). This value was converted into the corrected dermal NOAEC taking into account the absorption rates (oral 100 %, dermal 100 %) and the correction factor between human and experimental exposure conditions workers (5 working days vs. 7 days continuous exposure) of 1.4.

NOAEC corrected = 870 mg/kg bw/day * 100/100 * 1.4 = 1218 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Assessment factor for dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factors for workers
AF for the quality of the whole database:
1
Justification:
The quality of the database is considered to be good.
AF for remaining uncertainties:
1
Justification:
No additional factors are 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:
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:
2.52 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:
870 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
378.26 mg/m³
Explanation for the modification of the dose descriptor starting point:

A systemic NOAEL of 870 mg/kg bw /day was determined for the substance in an oral sub-acute Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in rats (OECD 422, GLP). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day, the absorption rates (a default factor of 2 is included (*0.5); in accordance with ECHA Guidance R.8 the absorption rate of the starting route is half that of the end route).

NOAEC corrected = 870 mg/kg bw/day * 1/1.15 m³/kg/day * 0.5 = 378.26 mg/m³

AF for dose response relationship:
1
Justification:
Assessment factor for dose response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are 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:
1.45 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:
870 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
870 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic NOAEL of 870 mg/kg bw /day was determined for the substance in an oral sub-acute Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Testin in rats (OECD 422, GLP). This value does not have to be corrected, as the dermal and oral absorption rates are both considered to be 100 % as a worst-case assumption.

AF for dose response relationship:
1
Justification:
Assessment factor for dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factors for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are 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:
DNEL (Derived No Effect Level)
Value:
1.45 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:
870 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
870 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic NOAEL of 870 mg/kg bw /day was determined for the substance in an oral sub-acute Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in rats (OECD 422, GLP). This value does not have to be corrected, as the oral absorption rates in human and rat are considered to be identical.

AF for dose response relationship:
1
Justification:
Assessment factor for dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required
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