Registration Dossier
Registration Dossier
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EC number: 200-579-1 | CAS number: 64-18-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 9.5 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.5 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Formic acid is classified as being highly corrosive to the skin (EC 1272/2008: Skin Corrosion 1A: H314; ECB ESIS: R35). According to the REACH regulation this precludes testing for the following endpoints
- Skin irritation (Annex VII; No. 8.1, column 2; Annex VIII; No. 8.1.1, column 2)
- eye irritation (Annex VII; No. 8.2, column 2; Annex VIII; No. 8.2.1, column 2)
- sensitisation (Annex VII; No. 8.3, column 2)
- acute toxicity (Annex VII; No. 8.5, column 2; Annex VIII; No. 8.5, column 2)
- Repeated dose testing by oral and dermal exposure is technically not possible (Annex XI Section 2). Reasons:
o The substance is corrosive in the dose range of interest for the study.
o Also, for reasons of animal welfare such studies should be avoided.
Thus, formic acid cannot be used as test substance whenever repeated doses are required. Alternatively, formate salts may be tested to examine systemic toxicity. Consequences regarding DNELs for formic acid itself are as follows:
1) Local effects prevail over systemic effects
2) Dermal DNEL:
The classification concentration limits set for skin corrosion may be used as qualitative information.
Index No |
International Chemical Identification |
EC No |
CAS No |
Classification |
Labelling |
Concentration Limits |
Notes |
607-001-00-0 |
formic acid … % |
200-579-1 |
64-18-6 |
C; R35 |
C R: 35 S: (1/2-)23-26-45 |
C; R35: C≥90 % C; R34: 10 %≤C < 90 % Xi; R36/38: 2 %≤C < 10 %
|
B |
3) Oral DNEL, consumer exposure
The classification concentration limits set for skin corrosion may be used as qualitative information.
4) Inhalation DNEL, worker
There is an EU Indicative Occupational Exposure Limit (IOEL) of 5 ppm (9 mg/m³; STEL: 9 mg/m³) published in the regulation 2006/15/EC that may be used directly for the inhalation DNEL,workers. As the IOEL is based on irritating properties, there is no additional factor for a short term exposure.
National German formic acid OELs are as follows:
- Binding Federal AGW: 5 ppm (9.5 mg/m³; STEL: factor 2). OEL set in 01/2006. Reference: TRGS 900 (02 July 2009)
- MAK-value: 5 ppm (9.5 mg/m³; STEL: factor 2). Reference: Deutsche Forschungsgemeinschaft (2006) MAK- und BAT-Werte-Liste 2009. Wiley-VCH, Weinheim. A document on the delineation of the MAK-value is publicly accessible. Reference: H.Greim, ed. (2003) Occupational Medicine 19, 169-180.
The pungent odor of formic acid is a warning sign that indicates exposure to formic acid and prevents extended exposure periods or exposure towards irritating concentrations. It can be reasonably assumed that the inhalation DNELs for local effects do also protect against systemic effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Formic acid is classified as being highly corrosive to the skin (EC 1272/2008: Skin Corrosion 1A: H314; ECB ESIS: R35). According to the REACH regulation this precludes testing for the following endpoints
- Skin irritation (Annex VII; No. 8.1, column 2; Annex VIII; No. 8.1.1, column 2)
- eye irritation (Annex VII; No. 8.2, column 2; Annex VIII; No. 8.2.1, column 2)
- sensitisation (Annex VII; No. 8.3, column 2)
- acute toxicity (Annex VII; No. 8.5, column 2; Annex VIII; No. 8.5, column 2)
- Repeated dose testing by oral and dermal exposure is technically not possible (Annex XI Section 2). Reasons:
o The substance is corrosive in the dose range of interest for the study.
o Also, for reasons of animal welfare such studies should be avoided.
Thus, formic acid cannot be used as test substance whenever repeated doses are required. Alternatively, formate salts may be tested to examine systemic toxicity. Consequences regarding DNELs for formic acid itself are as follows:
1) Local effects prevail over systemic effects
2) Dermal DNEL:
The classification concentration limits set for skin corrosion may be used as qualitative information.
Index No |
International Chemical Identification |
EC No |
CAS No |
Classification |
Labelling |
Concentration Limits |
Notes |
607-001-00-0 |
formic acid … % |
200-579-1 |
64-18-6 |
C; R35 |
C R: 35 S: (1/2-)23-26-45 |
C; R35: C≥90 % C; R34: 10 %≤C < 90 % Xi; R36/38: 2 %≤C < 10 %
|
B |
3) Oral DNEL, consumer exposure
The classification concentration limits set for skin corrosion may be used as qualitative information.
4) Inhalation DNEL, worker and consumer
There is an EU Indicative Occupational Exposure Limit (IOEL) of 5 ppm (9 mg/m³; STEL: 9 mg/m³) published in the regulation 2006/15/EC that may be used directly for workers. The IOEL is based on the irritating properties. Therefore, this concentration can also be used for consumers without corrections for differences regarding exposure period and respiration volumes between workers and consumers. However, an assesment factor of 3 (AF=3) should be applied in order to account for sensitive consumer subpopulations and possible continuous exposure. Therefore, the inhalation DNEL, consumer is set at 3 mg/m³. The pungent odor of formic acid is a warning sign that indicates exposure to formic acid and prevents extended exposure periods or exposure towards irritating concentrations.
It can be reasonably assumed that the inhalation DNELs for local effects do also protect against systemic effects.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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