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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.6 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
19.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral rat NOAEL is converted to an inhalatory rat NOAEC by using a default respiratory volume for the rat corresponding to 8 h exposure, which is the relevant duration of worker exposure (0.38 m³/kg bw) and by application of a factor of 2 for route to route extrapolation. The resulting rat inhalatory NOAEC is converted into inhalatory worker NOAEC by correction for respiratory rate based on activity (6.7 m³ for normal light activity versus 10 m³ for worker activity) and by correction for 5 day exposure (7 days versus 5 days): 16 * (1/0.38) * (1/2) * (6.7/10) * (7/5) = 19.7 mg/m³.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
guideline stuy
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:
0.5 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):
50
Dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
22.4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

As explained in the endpoint summary on toxicokinetics, metabolism and distribution, dermal absorption is likely low. But since it might be enhanced because of the irritating properties of the test substance, and no explicit value can be stated, the same absorbtion is assumed after dermal and oral exposure. The NOAEL has been corrected for a working week of 5 days (factor 7/5): 16 * (7/5) = 22.4 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
AF for interspecies differences (allometric scaling):
4
Justification:
default factor rat => human
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
guideline study
AF for remaining uncertainties:
1
Justification:
no further uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

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:
0.28 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):
25
Dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
7 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral rat NOAEL is converted into an inhalatory rat NOAEC by using a default respiratory volume for the rat corresponding to 24 h exposure, which is the relevant duration for general population, (1.15 m3/kg bw) and by application of a factor of 2 for route to route extrapolation: 16 * (1/2) * (1/1.15) = 7.0 mg/m³.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default
AF for the quality of the whole database:
1
Justification:
guideline study
AF for remaining uncertainties:
1
Justification:
no remainnig 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:
0.16 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):
100
Dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

As explained in the endpoint summary on toxicokinetics, metabolism and distribution, dermal absorption is likely low. But since it might be enhanced because of the irritating properties of the test substance, and no explicit value can be stated, the same absorbtion is assumed after dermal and oral exposure. No adaptation of the NOAEL has thus been performed.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
AF for interspecies differences (allometric scaling):
4
Justification:
default factor rat => human
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default
AF for the quality of the whole database:
1
Justification:
guideline study
AF for remaining uncertainties:
1
Justification:
no further uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.16 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):
100
Dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
AF for interspecies differences (allometric scaling):
4
Justification:
default factor rat => human
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default
AF for the quality of the whole database:
1
Justification:
guideline study
AF for remaining uncertainties:
1
Justification:
no further 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

Consumer DNELs have been derived to assess man via environment only. No consumer uses are foreseen for this substance.