Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
130 mg/m³
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
130 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
130 mg/m³
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
130 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL extrapolated from long term DNEL

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

The leading effect in humans is CNS toxicity and neurotoxicity including optical nerve toxicity (Greim, H. ed., Occupational Toxicants 16, 143 -155; 2001; Kawai et al., Int. Arch. Occup. Environm. Health 63, 311 -318; 1991; Frederick et al., Am. Ind. Hyg. Assoc. J. 45, 51 -55; 1984). These effects are not displayed in rats and mice and only to a minor degree in monkeys. Hence, a major part of the animal studies, though of scientific value, is of limited relevance to humans and therefore has not been assigned as key studies but as studies of supporting evidence.

The MAK level in Germany is 130 mg/m³ (100 ppm) and mainly built on the exposure-effect relations and the established innocuous concentrations in humans, taking into account the increase in respiratory volume during a work shift in relation to the respiratory volume of volunteers in the experimental environment of a volunteer study. The scientific rationale of the German MAK value, which will be translated into an OEL, is not yet publicly available.

The innocuous concentrations are related to the limited capacity in humans to convert formic acid into CO2. There is not much difference for this metabolic threshold after single or repeated exposure, hence, the MAK value which is mainly based on singular experiences in humans is considered to be valid also for chronic exposure.

Exposure to 130 mg/m³ during a working shift is roughly equivalent to a dose of 1.3 g/person/day (20 mg/kg bw and day) which may be considered as a systemic DNEL (20 mg/kg bw/day), too, if the dermal uptake is the same as from inhalation (which is a worst-case consideration neglecting also the high volatility of the material). The systemic inhalation DNEL is considered to be also protective from local irritation.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
DNEL extrapolated from long term DNEL

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
DNEL extrapolated from long term DNEL

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:
4 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

For the general population, e. g. customer exposure, the workplace DNELs are divided by 5 in order to take into account possibly wider variability of interindividual sensitivities.

Exposure to 130 mg/m³ during a working shift is roughly equivalent to a dose of 1.3 g/person/day (20 mg/kg bw and day) which may be considered as a systemic DNEL (20 mg/kg bw/day), too, if the dermal and oral uptake is the same as from inhalation (which is a worst-case consideration neglecting also the high volatility of the material). For the general popolation, the systemic inhalation DNEL of 4 mg/kg bw and day is considered to be also protective from local irritation and the hazard from oral exposure.