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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.65 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
123.4 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL of 50 mg/kg bw/d is converted to a NOAEC by dividing by 0.38 m3/kg bw and multiplication with 6.7/10 to correct for worker ventilation and multiplicaton with 7/5 to correct for 7 days/week experimental exposure vs. 5 working days per week,according to ECHA Guidance R8. According to the toxicokinetic assessment, no difference in bioavailability after inhalation or oral exposure is considered relevant for this substance.
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEC
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling factor rat-human not applied for inhalation route as considered in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
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:
2.92 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):
300
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
875 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
According to the toxicokinetic assessment, the absorption rate from dermal route is assumed to be 8% and the absorption rate of oral route is considered to be 100%. Therefore, the oral NOAEL of 50 mg/kg bw/d is converted to a NOAEL of dermal route by dividing by 0.08 and by multiplicaton with 7/5 to correct for 7 days/week experimental exposure vs. 5 working days per week
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor rat-human
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
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

According to the results of toxicokinetic assessment, the inhalation route is not considered a very relevant exposure route and uptake rate via inhalation is smaller than via the oral route so that, conservatively, the ratio of inhalation and oral bioavailability is assumed as 1. In addition, the absorption rate from dermal route is assumed to be 8% and the absorption rate of oral route is considered to be 100%. Therefore, the oral NOAEL of 50 mg/kg bw/d is converted to a dermal NOAEL of 500 mg/kg/day by dividing by 0.08 and multiplicaton with 7/5 to correct for 7 days/week experimental exposure vs. 5 working days per week.

As basis for DNEL derivation the result from a sub-chronic study with rats was used, performed according to OECD 422 under GLP. In this study, the test item was administered at dosages of 50, 250, and 1000/500 mg/kg body weight/day, and controls received the vehicle only. Based on the results of this study, a NOAEL (No Observed Adverse Effect Level) for systemic toxicity in rats was considered to be 50 mg/kg bw/day. Hence this study is chosen as basis for DNEL derivation. Based on the above description, the basis for the DNEL therefore is this oral NOAEL (50 mg/kg bw/day), and NOAELcorr for the dermal route is 875 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalative NOAEC(Worker) by dividing by 0.38 m³/kg and multiplying by 6.7/10 to take account for light work activities resulting in a NOAEC of 88.16 mg/m³ and multiplicaton with 7/5 to correct for 7 days/week experimental exposure vs. 5 working days per week.

No acute effects were seen in other studies performed using the substance, and therefore DNELs for acute effects were not derived.

General Population - Hazard via inhalation 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
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:
no hazard 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:
no hazard identified

Additional information - General Population

With regard to consumer exposure the substance under concern is used only in cosmetic products. Therefore, the derivation of DNELs, assessment of exposure and risk characterization are not required (ECHA guidance on information requirements and chemical safety assessment - Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012, ECHA-2010 -G-19 -EN). Furthermore, no indirect exposure assessment is necessary in accordance toECHA guidance on information requirements and chemical safety assessment - Chapter R.16: Environmental exposure assessment, Version 3.0, February 2016, ECHA-16 -G-03 -EN.