Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.43 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
BMDL10
Value:
4.37 mg/kg bw/day
Modified dose descriptor starting point:
BMCL10
Value:
5.39 mg/m³
Explanation for the modification of the dose descriptor starting point:

BMCL10corr = BMDL10oral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h))*(7 days/5 days) = 4.37 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(0.5/1)*0.67*1.4 = 5.39 mg/m³.

As worst case as recommended in the ECHA Guidance R.8 (2012), it is assumed that oral absorption rate is 50% of that of inhalation absorption. ABS(oral/rat) = oral absorption rate in rats, ABS(inh./human) = inhalation absorption rate in humans.

Differences in the experimental (7 days/week) and human exposure conditions (worker: 5 days/week) were considered.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a BMDL10. The lower 95% confidence level of the BMC10 replaces the NOAEL as starting point.
AF for differences in duration of exposure:
1
Justification:
The effects on parturition are at a first instance considered to be limited to exposure during pregnancy. Therefore no AF allowing for differences in the experimental exposure duration is used.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
Default value for workers according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on high-quality studies (OECD 422 Guideline study).
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 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:
BMDL10
Value:
4.37 mg/kg bw/day
Modified dose descriptor starting point:
BMDL10
Value:
6.12 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

BMDL10dermal = BMDL10oral*ABS(oral)/ABS(dermal)*(7 days/5 days) = 4.37 mg/kg bw/day *(1/1)*1.4 = 6.12 mg/kg bw/day.

It is assumed that oral and dermal absorption rates are equal.

Differences in the experimental (7 days/week) and human exposure conditions (worker: 5 days/week) were considered.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a BMDL10. The lower 95% confidence level of the BMC10 replaces the NOAEL as starting point.
AF for differences in duration of exposure:
1
Justification:
The effects on parturition are at a first instance considered to be limited to exposure during pregnancy. Therefore no AF allowing for differences in the experimental exposure duration is used.
AF for interspecies differences (allometric scaling):
4
Justification:
The experimental animal was rat.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
Default value for workers according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on high-quality studies (OECD 422 Guideline study).
AF for remaining uncertainties:
1
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:
0.076 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
BMDL10
Value:
4.37 mg/kg bw/day
Modified dose descriptor starting point:
BMCL10
Value:
1.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

BMCL10corr = BMDL10oral*(1/1.15 m³/kg bw/day (24h)) *(ABSoral-rat/ABSinh-human) = 4.37 mg/kg bw/day*(1/1.15 m³/kg bw/day)*(0.5/1) = 1.9 mg/m³.

As worst case as recommended in the ECHA Guidance R.8 (2012), it is assumed that oral absorption rate is 50% of that of inhalation absorption. ABS(oral/rat) = oral absorption rate in rats, ABS(inh./human) = inhalation absorption rate in humans.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a BMDL10. The lower 95% confidence level of the BMC10 replaces the NOAEL as starting point.
AF for differences in duration of exposure:
1
Justification:
The effects on parturition are at a first instance considered to be limited to exposure during pregnancy. Therefore no AF allowing for differences in the experimental exposure duration is used.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default value for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on high-quality studies (OECD 422 Guideline study).
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.044 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
BMDL10
Value:
4.37 mg/kg bw/day
Modified dose descriptor starting point:
BMDL10
Value:
4.37 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

BMDL10dermal = BMDL10oral*ABS(oral)/ABS(dermal) = 4.37 mg/kg bw/day *(1/1) = 4.37 mg/kg bw/day. It is assumed that oral and dermal absorption rates are equal.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a BMDL10. The lower 95% confidence level of the BMC10 replaces the NOAEL as starting point.
AF for differences in duration of exposure:
1
Justification:
The effects on parturition are at a first instance considered to be limited to exposure during pregnancy. Therefore no AF allowing for differences in the experimental exposure duration is used.
AF for interspecies differences (allometric scaling):
4
Justification:
The experimental animal was rat.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default value for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on high-quality studies (OECD 422 Guideline study).
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The test substance is not classified for acute dermal toxicity according to Regulation (EC) No 1272/2008 (CLP).

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:
0.044 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
BMDL10
Value:
4.37 mg/kg bw/day
Modified dose descriptor starting point:
BMDL10
Value:
4.37 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

no route to route extrapolation necessary

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a BMDL10. The lower 95% confidence level of the BMC10 replaces the NOAEL as starting point.
AF for differences in duration of exposure:
1
Justification:
The effects on parturition are at a first instance considered to be limited to exposure during pregnancy. Therefore no AF allowing for differences in the experimental exposure duration is used.
AF for interspecies differences (allometric scaling):
4
Justification:
The experimental animal was rat.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default value for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on high-quality studies (OECD 422 Guideline study).
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