Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
NOAEC
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:
6.42 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
144
Modified dose descriptor starting point:
NOAEL
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 Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.06 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
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:
3.85 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
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:
0.39 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
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

Source chemical

EC number

931-291-0

CAS number

Not available

IUPAC name

Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid

 Common name  Amphoacetates C8-18

Based on their structural similarity, similar composition, physico-chemical and toxicological properties, the substance and the source chemical are considered part of the same chemical category. Further, the substance for which the DNELs are derived is the main constituent in the source chemical. In the report “Category Approach for REACH Registration of ALKYLAMPHOACETATES” the category is documented (see IUCLID Chapter 13).

Relevant starting points, considering the available data

Considering the available data, the following starting points on the source chemical are considered relevant.

 

Endpoint

Result

Sub-acute oral repeated dose toxicity study (rat)

NOAEL: 92.5 mg/kg bw/day

 

Basis: a dose-dependent effect on liver weight. At the LOAEL, the liver weights were > 10% higher compared to the control. The presence of such an increased liver weight needs to be considered as a potential serious effect after prolonged exposure and should not be considered as a physiological adaptive response without further thought.

Reproductive toxicity

No reproduction/ developmental study conducted, but histological examinations were performed on the reproductive organs of the 10 male and 10 female rats in the highest dose group in the 28-day study, showing no effects on these organs.

Route-to-route extrapolation

For the derivation of the DNELs:

Long-term – dermal, systemic effects

Long-term – inhalation, systemic effects

Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for. A certified toxicologist assessed the toxicokinetic behaviour of the substance (in accordance with Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance):

Absorption oral (rat) = Absorption oral (human) = 100%

Absorption dermal (human) = 10%

Absorption inhalation (human) = 100%

Assessment factors

The assessment factors (AFs) that are applied to obtain the endpoint-specific DNELs for the relevant exposure pattern are based on the ECETOC report “Guidance on assessment factors to derive DNELs”. In the following overview the relevant AFs are shown: 

Aspect

Assessment Factor (AF)

Interspecies extrapolation; rat to human, for the dermal and oral route (inhalation route: not applicable)

4

(to correct for metabolic rate)

 

Intraspecies extrapolation; worker

3

Intraspecies extrapolation; general population

5

Exposure duration; sub-acute to chronic

6

(to correct for difference in study duration and actual exposure situation)

Dose-response

1

(default, as the starting point is a NOAEL)

Quality of whole database

2

(to compensate for the lack of a reproduction/developmental study)

As the substance considered is the main constituent of the source chemical, no additional factor is deemed necessary.

Leading to the following Assessment Factors: 

 

Assessment Factor

DNEL

Worker

General population

Long-term – dermal, systemic effects

144

240

Long-term – inhalation, systemic effects

36

60

Long-term – oral,

systemic effects

Not relevant

240