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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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

Workers - 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

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:
24.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
8
Dose descriptor starting point:
NOAEC
Value:
775 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
193.75 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL for infrequent inhalation exposures

Correction for exposure duration (6h/24h) was applied, but no correction for number of exposures (5d/7d) was made as infrequent exposure is expected. Therefore, 775*(6/24) = 193.75 mg/m³

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Default for infrequent exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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:
27.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
32
Dose descriptor starting point:
NOAEC
Value:
775 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
891.25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. No correction for dosing frequency: 5 days/7 days. Therefore, the corrected NOAEL for repeat-dose systemic effects via the oral route is: inhaled 775*1.15 = 891.25 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Default for infrequent exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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:
1.95 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):
32
Dose descriptor starting point:
NOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
62.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No correction to dose descriptor starting point was applied.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Default for infrequent exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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