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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
29.6 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:
1 200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 481 mg/m³
Explanation for the modification of the dose descriptor starting point:

There are no adequate experimental data on the inhalation route available. Therefore, the worker-DNEL long-term for inhalation route - systemic is derived from the NOAEL of 1200 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in rats. The NOAECcorr. is calculated as follows:

- standard respiratory volume rat = 0.38 m³/kg/8h

- standard respiratory volume human = 6.7 m³/8h

- worker respiratory volume = 10 m³/8h

- absorption (oral, rat) = 50 % (default)

- absorption (inhalative, human) = 100 % (default)

--> modified dose descriptor (corrected inhalatory NOAEC) = 1200 mg/kg bw/day * (1/0.38 m³/kg/d) * (6.7 m³ (8h)/10 m³ (8h)) * (0.5/1) * (7 exposure days/week; rat/5 exposure days/week; worker) = 1481 mg/m³

AF for dose response relationship:
1
Justification:
ECHA Reach Guidance (starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
2
Justification:
ECAH REACH Guidance (subchronic --> chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
2
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
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:
420 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):
20
Dose descriptor starting point:
NOAEL
Value:
1 200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
8 400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There are no experimental data on repeated exposure by the dermal route available. Therefore, the worker-DNEL long-term for dermal route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAELcorr. is calculated as follows:

- absorption (oral, rat) = 50 % (default)

- absorption (dermal, human) = 10 % (assumed as worst case)

--> modified dose descriptor (corrected dermal NOAEL) = 1200 mg/kg bw/day * (0.5/0.1) * (7 exposure days/week; rat/5 exposure days/week; worker) = 8400 mg/kg bw/day

AF for dose response relationship:
1
Justification:
No effects were observed, dose response is therefore irrelevant.
AF for differences in duration of exposure:
1
Justification:
As no effects were observed, no time extrapolation was performed. Worsening of effects is not expecte with time.
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
No effects were observed. The cleavage products are food ingredients, therefore toxicodynamic differences are not expected
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
All relevant endpoints are covered
AF for remaining uncertainties:
1
Justification:
Remaining uncertainties are not expected
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 registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels.

The read across substance does not cause systemic effects and the only local effect was eye irritation. A 112 day oral toxicity study in the rat is available for DNEL derivation. Because of the low vapor pressure and the identified exposure scenarios, inhalation exposure to the substance is not expected. Instead, a dermal DNEL was derived according to ECHA Guidance on Information requirements and chemical safety assessment Chapter R.8 (2008).

Route to route extrapolation: The oral NOAEL of > 1200 mg/kg bw was converted to a dermal NOAEL of the same magnitude as dermal absorption is not expected to be higher than oral absorption. Allometric scaling was applied for rat to human with a factor of 4. Toxicodynamic differences between rats and humans are not expected to play a role as the cleavage products of the substance are food ingredients that are consumed on a gram bases by humans. The default factor extrapolation for workers (5) was used for interspecies extrapolation. Because no effect was observed in the subchronic study, it is difficult to imagine a worsening with exposure duration. Therfore, time extrapolation was not performed.

For the worker, wearing of goggles is reccomended because of the eye irritant properties of the neat material.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
DNEL related information
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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