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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
12.8 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:
129.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
319.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h))*(fexpo-rat/fexpo-human) = 129.6 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(1/1)*0.67*7/5 = 319.9 mg/m³.

ABSoral-rat = oral absorption rate in rats

ABSinh-human = inhalation absorption rate in humans

Due to metabolic considerations (enzymatic ester hydrolysis), it is assumed that the oral absorption rate is 100% of that of the inhalation absorption rate.

fexpo-rat = frequency of exposure of test animals = 7 days/week

fexpo-human = frequency of exposure of workers = 5 days/week

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a subchronic (90-day) study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
18.14 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:
129.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 814 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human)*(fexpo-rat/fexpo-human) = (129.6 mg/kg bw/day)*(1/0.1)*(7/5) = 1814 mg/kg bw/day

ABSoral-rat=oral absorption rate in rats

ABSdermal-human=dermal absorption rate in humans

It is assumed that the dermal absorption rate is 10% of that of the oral absorption according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R7c, Figure R.7.12-5.

fexpo-rat = 7 days/week

fexpo-human = 5 days/week

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a subchronic (90-day) study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

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:
2.254 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):
50
Dose descriptor starting point:
NOAEL
Value:
129.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
112.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr = NOAELoral*(1/1.15 m³/kg bw/day)*(ABSoral-rat/ABSinh-human) = 129.6 mg/kg bw/day*(1/1.15 m³/kg bw/day)*(1/1) = 112.7 mg/m³

ABSoral-rat=oral absorption rate in rats

ABSinh-human=inhalation absorption rate in humans

Due to metabolic considerations (enzymatic ester hydrolysis), it is assumed that the oral absorption rate is 100% of that of the inhalation absorption rate.

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a subchronic (90-day) study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
6.48 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):
200
Dose descriptor starting point:
NOAEL
Value:
129.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 296 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (129.6 mg/kg bw/day)*(1/0.1) = 1296 mg/kg bw/day

ABSoral-rat=oral absorption rate in rats

ABSdermal-human=dermal absorption rate in humans

It is assumed that the dermal absorption rate is 10% of that of the oral absorption according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R7c, Figure R.7.12-5.

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a subchronic (90-day) study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
0.648 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):
200
Dose descriptor starting point:
NOAEL
Value:
129.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
129.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation is needed.

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a subchronic (90-day) study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

In accordance with Article 14(5b) of the REACH Regulation (EC) No. 1907/2006, the chemical safety report does not need to include considerations of the risks to human health from the end uses in cosmetics products within the scope of Directive 76/768/EEC. Since exposure to consumers is limited to the end use of the registered substance in cosmetics products, the chemical safety report does not include consideration of the risks to human health from this particular end use and, therefore, no exposure assessment and risk characterisation is conducted for consumer uses.