Registration Dossier

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
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:
60 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
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal absorption is not considered to be higher than oral absorption, default extrapolation factor: 1
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:
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:
30 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):
40
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal absorption is not considered to be higher than oral absorption, default extrapolation factor: 1
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:
10
Justification:
Default factor for the general population.
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 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):
40
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation needed to be performed
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:
10
Justification:
Default factor for the general population.
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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

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 and oral 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. For the oral DNEL, no route to route extrapolation was performed. 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 the general population (10) 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.

The substance is not expected to be an eye irritant when used in consumer formulations, hence no risk mitigation is required.