Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.5 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17 µg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
240
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
40
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

The target substance is an UVCB-substance, with no fixed composition and only one identified and quantified constituent, 2 -ethylhexanol. Therefore the use of (Q)SAR-methodology and read-across is difficult to perform in order to provide appropriate effect levels for chemical safety assessment. Suitable effect levels for repeated toxicity via dermal route were established based on the repeated-dose toxicity study performed for 2 -ethylhexanol. The study was performed with Fischer F344 rats following the current U. S. EPA Good Laboratory Practice Guidelines. In the absence of data on the target UVCB-substance these studies serve as a good surrogate studies. The effect levels of the only identified and quantified constituent of the target substance, 2 -ethylhexanol, via dermal route can be considered appropriate for this route. The target substance did not exhibit acute dermal toxicity (section 7.2.3) when tested up to 2000 mg/kg, no irritation was noticed upon removal occlusive patch and no skin irritation/corrosion was observed in in vitro testing (section 7.3.1). The target substance showed skin sensitisation (section 7.4.1) potency in LLNA test. It can be considered that the safe use of the substance can be derived using these data. Inhalation toxicity cannot be considered to raise a concern, since the actual target UVCB-substance has low vapour pressure. Qualitative assessment at elevated temperatures was taken into account since vapour pressure of the target substance is dependent on temperature (see chapter 9 of CSR).

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:
DNEL (Derived No Effect Level)
Value:
3.5 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17 µg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
240
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
40
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

The only identifiable component of this UVCB-substance is 2 -ethylhexanol, therefore well established and published studies demonstrating the toxic properties of 2 -ethylhexanol were used to derive relevant DNEL-values. It is not justified to further test this UVCB-substance, since its toxic properties for human health can be derived from the information from other sources like 2 -ethylhexanol.

Oral toxicity: the studies presented in section 7.5.1 (Repeated dose toxicity: oral.001) exhibited suitable effect levels for repeated toxicity via oral route. Repeated-dose toxicity studies performed with the only identified and quantified constituent of the target substance, 2-ethylhexanol. Studies performed with Fischer F344 rats and B6C3F1 mice followed the current U. S. EPA Good Laboratory Practice Guidelines. In the absence of data on the target substance these studies serve as a good surrogate studies.

Dermal toxicity: the studies presented in section 7.5.3 (Repeated dose toxicity: dermal.001) exhibited suitable effect levels for repeated toxicity via dermal route. Repeated-dose toxicity studies performed with the only identified and quantified constituent of the target UVCB-substance, 2-ethylhexanol. Studies performed with Fischer F344 rats followed the current U. S. EPA Good Laboratory Practice Guidelines. In the absence of data on the target substance these studies serve as a good surrogate studies.

Inhalation toxicity: inhalation toxicity was assessed qualitatively based on information derived from the surrogate substance, 2-ethylhexanol (section 7.5.2, Repeated dose toxicity: inhalation.001). In the qualitative assessment elevated temperatures were taken into account since vapour pressure of the target substance is dependent on temperature (see chapter 9 of CSR).