Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
450 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):
5
Modified dose descriptor starting point:
NOAEC
Value:
2 250 mg/m³
Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.
AF for other interspecies differences:
1
Justification:
There is no evidence for species differences in the general mode of action or kinetics.
AF for intraspecies differences:
5
Justification:
The default value for the relatively homogenous group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and not critical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
By inhalation
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:
514.29 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):
7
Modified dose descriptor starting point:
NOAEL
Value:
3 600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. Based on the physical chemical properties of the substance (inorganic ionic substance, with high water solubility) a dermal absorption rate of 25% through skin was selected.
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1.4
Justification:
The default allometric scaling factor for the differences between dogs and humans is used.
AF for other interspecies differences:
1
Justification:
There is no evidence for species differences in the general mode of action or kinetics.
AF for intraspecies differences:
5
Justification:
The default value for the relatively homogenous group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and not critical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are 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

General

DNEL derivation for the substance Acesulfame potassium is performed under consideration of the recommendations of ECHA. In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.

Workers – Hazard via inhalation route

Long term systemic inhalation DNEL, worker

Calculation of dose descriptor

Step 1: Selection of the relevant dose descriptor (starting point):

For risk characterisation a inhalation NOAEC was derived by route to route extrapolation. The oral NOAEL of 900 mg/kg bw/day, obtained from chronic repeated dose toxicity testing in dogs by Reuzel PGJ, van der Heijden CA, 1977 (see 7.5.1, T04091), was considered as key value for the chemical safety assessment and therefore, most relevant starting point.

Step 2: Modification into a correct starting point:

In a first step the oral NOAEL was transferred to humans with a factor of 1.4 for allometric scaling from dogs. For worker a NOEC long-term, inhalation was calculated assuming 70 kg per person, 8h light activity (10 m³ breathing volume), 50 % absorption via oral routes and 100 % absorption via inhalatory routes.

NOEC (Worker)inhalation = 900 mg/kg bw/day * 1/1.4 *70 kg * 1/10 m³ * 50%Abs, (oral) / 100 %

Abs, (inhal) =2250 mg/m³

Step 3: Use of assessment factors: 5

Interspecies: no allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.

Interspecies AF, remaining differences: 1

Intraspecies AF (worker): 5

In conclusion the long term systemic inhalation DNEL workers was calculated to be 450 mg/m³ bw/day.

Short term acute inhalation DNEL, worker

The test material is not classified and labelled for acute dermal toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Thus, in accordance with “Guidance on information requirements and chemical safety assessment chapter R8: Characterisation of dose (concentration)- response for human health” no DNEL is required.

Local effects

No specific data on respiratory irritation is available. As the substance is not classified as skin and eye irritating also no adverse effects on respiratory system is expected. No inhalation toxicity and no signs of respiratory irritation of thermal degradation products tested at 250 °C were noted. Based on the physical parameters a peak exposure is not expected. The substance is solid with a low vapour pressure. Thus, no DNEL is required.

Workers – Hazard via dermal route

Long term systemic dermal DNEL, worker

Calculation of dose descriptor

Step 1: Selection of the relevant dose descriptor (starting point):

For risk characterisation a inhalation NOAEC was derived by route to route extrapolation. The oral NOAEL of 900 mg/kg bw/day, obtained from chronic repeated dose toxicity testing in dogs by Reuzel PGJ, van der Heijden CA, 1977 (see 7.5.1, T04091), was considered as key value for the chemical safety assessment and therefore, most relevant starting point.

Step 2: Modification into a correct starting point:

Based on the physical chemical properties of the substance (inorganic ionic substance, with high water solubility) a dermal absorption rate of 25 % through skin was selected.

In conclusion, dermal NOAEL = oral NOAEL x [ABS oral dog /ABS dermal human] = 900 mg/kg bw/day x (100/25) = 3600 mg/kg bw/d.

Step 3: Use of assessment factors: 7

Interspecies AF, allometric scaling (dog to human): 1.4

Interspecies AF, remaining differences: 1

Intraspecies AF (worker): 5

Exposure duration AF (chronic exposure period): 1

In conclusion the long term systemic dermal DNEL workers were calculated to be 514.29 mg/kg bw/day.

Acute short term dermal DNEL, worker

The test material is not classified and labelled for acute dermal toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Thus, in accordance with “Guidance on information requirements and chemical safety assessment chapter R8: Characterisation of dose (concentration)- response for human health” no DNEL is required.

Local effects

Worker local DNEL for dermal route does not need to be derived as no dermal and eye irritation and no skin sensitisation (leading to C&L) has been identified (in accordance with "Guidance on information requirements and chemical safety assessment, chapter R8: Characterisation of dose (concentration)- response for human health").

Worker – Hazard for the eyes

According to the EU (DSD and GHS) criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.

References

(not included as endpoint study record)

- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2. ECHA-2010-G-19–EN.

- ECHA (2010). Guidance on information requirements and chemical safety assessment.Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. May 2008

- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.

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:
DNEL (Derived No Effect Level)
Value:
64.29 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):
14
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation necessary as the basis is the chronic oral study in dogs.
AF for dose response relationship:
1
Justification:
The dose response relationship is considered not remarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1.4
Justification:
The default allometric scaling factor for the differences between dogs and humans is used.
AF for other interspecies differences:
1
Justification:
There is no evidence for species differences in the general mode of action or kinetics.
AF for intraspecies differences:
10
Justification:
The default value is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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

General

DNEL derivation for the substance Acesulfame potassium is performed under consideration of the recommendations of ECHA. In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.

General population – Hazard via oral route

Long term systemic oral DNEL, general population

Step 1: Selection of the relevant dose descriptor (starting point):

The oral NOAEL of 900 mg/kg bw/day, obtained from chronic repeated dose toxicity testing in dogs by Reuzel PGJ, van der Heijden CA, 1977 (see 7.5.1, T04091), was considered as key value for the chemical safety assessment and therefore, most relevant starting point.

Step 2: Use of assessment factors: 14

Interspecies AF, allometric scaling (dog to human): 1.4

Interspecies AF, remaining differences: 1

Intraspecies AF (general population): 10

Exposure duration AF (chronic exposure period): 1

In conclusion the long term systemic oral DNEL general population was calculated to be 64.29 mg/kg bw/day.

Acute/short term oral DNEL, general population

The test material is not classified and labelled for acute oral toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Thus, in accordance with “Guidance on information requirements and chemical safety assessment chapter R8: Characterisation of dose (concentration)- response for human health” no DNEL is required.

General population – Hazard for the eyes

According to the EU (DSD and GHS) criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.

General comment

It is noteworthy to mention that based on the study in dogs, the overall NOAEL of 30000 ppm (corresponding to 900 mg/kg bw/day) was used to establish the acceptable daily intake (ADI) for Acesulfame potassium of 0 - 9 mg/kg bw by the Joint FAO/WHO Expert Committee on Food Additives (1990) and after re-evaluation of the European Scientific Committee on Food (SCF, 2000).

References

(not included as endpoint study record)

- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2. ECHA-2010-G-19–EN.

- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. May 2008

- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.