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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.55 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
18
Dose descriptor starting point:
NOAEL
Value:
26 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
45 mg/m³
Explanation for the modification of the dose descriptor starting point:

Based on te toxicokinetic assessment, default values of 100% are used for both oral and respiratory absorption. A standard respiratory volume of 0.38 m3/kg/day in rat (considering 8 hours exposure) and a standard respiratory volume of 6.7 m3/person for a person at rest and 10 m3/person for a worker performing light activity (for 8 hours expsoure) were considered. 

AF for dose response relationship:
1
Justification:
Default value, PoD is NOAEL. There is no evidence of a steep dose-relationship, and a reliable NOAEL can be derived based on the dose range tested.
AF for differences in duration of exposure:
6
Justification:
The NOAEL was derived in a subacute repeated exposure (reprotoxicity / developmental study); the extrapolation factor to the chronic exposure duration is 6
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling is required from an oral animal study to human inhalation
AF for other interspecies differences:
1
Justification:
Additional assessment factors for interspecies diferences are not needed, as has been concluded in the ECETOC report (TR 110, 2010), based on a review of the scientific literature.
AF for intraspecies differences:
3
Justification:
Default for workers. An assessment factor of 3 has been used to account for the intraspecies differences. This factor has been retrieved by ECETOC (TR 110, 2010). The ECETOC analysis has been based on a comparison between animal and actual human data that per se includes intraspecies variability in humans. In addition, the human population under investigation comprised cancer patients, this represents a very sensitive subpopulation.
AF for the quality of the whole database:
1
Justification:
Data from a reliable guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties. The NOAEL is considered appropriate for the DNEL derivation.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
developmental toxicity / teratogenicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

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:
0.5 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor starting point:
NOAEL
Value:
26 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
17.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

Based on toxicokinetics assessment, default values of 100% are derived for both oral and repsiratory absorption. A standard respiratory volume of 1.15 m3/kg for rats (considering 24 hours exaposure) was used. 

AF for dose response relationship:
1
Justification:
PoD is NOAEL. There is no indication of a steep dose-response, and a reliable NOAEL can be derived from the dose range tested.
AF for differences in duration of exposure:
6
Justification:
The NOAEL is derived in a subacute toxicity study; the assessment factor for teh extrapolation to chronic exposure is 6.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling is required for the extrapolation from an oral animal study to the respiratory human exposure.
AF for other interspecies differences:
1
Justification:
Additional assessment factors for interspecies differences are not needed, as has been concluded in ECETOC report (TR 110, 2010) based on a review of the scientific literature.
AF for intraspecies differences:
5
Justification:
Default value general population. An assessment factor of 5 has to be used to account for the intraspecies differences, as has been concluded by ECETOC (TR 110, 2010) based on a review of the scientific literature. The ECETOC analysis has been based on a comparison between animal and actual human data that per se includes intraspecies variability in humans. In addition, the human population under investigation comprised cancer patients, this represents a very sensitive subpopulation.
AF for the quality of the whole database:
1
Justification:
The NOAEL is derived in a GLP compliant OECD guideline study
AF for remaining uncertainties:
1
Justification:
The NOAEL is considered appropriate for the DNEL derivation
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:
0.13 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
26 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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