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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
42.32 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
528.95 mg/m³
Explanation for the modification of the dose descriptor starting point:

Due to a lack of experimental data the NOAEC (corr) was derived including ECHAs recommended absorption rates for exposure via the oral (50 %) and inhalation (100 %) route.

AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
1
Justification:
default (no AF needed as the dose descriptor was obtained from a chronic toxicity study)
AF for interspecies differences (allometric scaling):
1
Justification:
Covered by route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default (worker)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties 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:
DNEL (Derived No Effect Level)
Value:
12 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):
50
Dose descriptor starting point:
NOAEL
Value:
12 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Available data do not suggest a pronounced difference between oral and dermal route. Due to a lack of experimental data the NOAEL (corr) was derived including equal absorption rates for exposure via the oral (100 %) and dermal (100 %) route.

AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
1
Justification:
default (no AF needed as the dose descriptor was obtained from a chronic toxicity study)
AF for interspecies differences (allometric scaling):
4
Justification:
default (rat/human)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default (worker)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties 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:
low hazard (no threshold derived)

Additional information - workers

The hazard assessment of this substance is triggered by the effects observed in a chronic repeated dose toxicity study. In addition, adverse effects on the eye were reported in an in vivo eye irritation study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.43 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:
600 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
260.87 mg/m³
Explanation for the modification of the dose descriptor starting point:

Due to a lack of experimental data the NOAEC (corr) was derived including ECHAs recommended absorption rates for exposure via the oral (50 %) and inhalation (100 %) route.

AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
1
Justification:
default (no AF needed as the dose descriptor was obtained from a chronic toxicity study)
AF for interspecies differences (allometric scaling):
1
Justification:
Covered by route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default (general population)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties 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:
DNEL (Derived No Effect Level)
Value:
6 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:
600 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Available data do not suggest a pronounced difference between oral and dermal route. Due to a lack of experimental data the NOAEL (corr) was derived including equal absorption rates for exposure via the oral (100 %) and dermal (100 %) route.

AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
1
Justification:
default (no AF needed as the dose descriptor was obtained from a chronic toxicity study)
AF for interspecies differences (allometric scaling):
4
Justification:
default (rat/human)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default (general population)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Acute risks from dermal exposure can be considered to be insignificant based on the results from a acute dermal toxicity study. Nevertheless, the long-term systemic dermal DNEL is considered to be protective also with regard to any potential acute hazards.

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:
6 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:
600 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification of the dose descriptor starting point is necessary as an oral NOEAL is used for hazard assessment.

AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
1
Justification:
default (no AF needed as the dose descriptor was obtained from a chronic toxicity study)
AF for interspecies differences (allometric scaling):
4
Justification:
default (rat/human)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default (general population)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties 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:
low hazard (no threshold derived)

Additional information - General Population

The hazard assessment of this substance is triggered by the effects from a chronic repeated dose toxicity study. In addition, adverse effects on the eye were reported in an in vivo eye irritation study.