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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
31.6 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
789 mg/m³
Explanation for the modification of the dose descriptor starting point:

Based on the NOAEL as derived in the 90 -day study with route to route extrapolation.

NOAELoral/0.38 with absorption oral/inhal rat = absorption oral/inhal human and absorption via inhalation and oral route is 10%

AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
2
Justification:
based on 90-day study
AF for interspecies differences (allometric scaling):
1
Justification:
starting point is inhalatory NOAEC (factor of 0.38 to correct for differences in respiratory rate between rat and human)
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor for worker exposure
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
No adverse effects on the male and female reproductive system were found in the 90-day study
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 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:
300 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:
absorption oral/dermal rat = absorption oral/dermal human and absorption via dermal and oral route is 10%
AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
2
Justification:
based on sub-chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor for allometric scaling rat-human
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor for worker exposure
AF for the quality of the whole database:
1
Justification:
standard database with as starting point an OECD 408 study according to the guidelines and under GLP
AF for remaining uncertainties:
1
Justification:
No adverse effects on the male and female reproductive system were found in the 90-day study
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
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:
no hazard identified
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

No consumer exposure is anticipated.