Formic acid, manufacture of, by-products from

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Data source

Reference

Reference 1

Reference Type:

publication

Title:

REGULATION (EC) No 1272/2008 of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

Year:

2008

Bibliographic source:

Official Journal of the European Union, L353, Volume 51

Report date:

2008

Reference 2

Reference Type:

other: EU classification

Title:

Formic acid Cas# 64-18-6

Author:

ECB (2006) Formic acid cas# 64-18-6

Year:

2006

Bibliographic source:

European Chemical Bureau. ESIS (European chemical substances information system). Available at http://ecb.jrc.it.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Formic acid

EC Number:

200-579-1

EC Name:

Formic acid

Cas Number:

64-18-6

Molecular formula:

CH2O2

IUPAC Name:

formic acid

Constituent 2

Reference substance name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Constituent 3

Reference substance name:

Propylidynetrimethanol

EC Number:

201-074-9

EC Name:

Propylidynetrimethanol

Cas Number:

77-99-6

Molecular formula:

C6H14O3

IUPAC Name:

2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Constituent 4

Reference substance name:

Pentaerythritol

EC Number:

204-104-9

EC Name:

Pentaerythritol

Cas Number:

115-77-5

Molecular formula:

C5H12O4

IUPAC Name:

2,2-Bis(hydroxymethyl)-1,3- propanediol

Test material form:

liquid: viscous

Results and discussion

Any other information on results incl. tables

At the 12^thATP, the European Union labelled formic acid as R35 (causes severe burns), based on sufficient available information. Specific concentration limits for preparations were set allowing formulations to be to be classified with respect to irritation/corrosion to the skin.

 

Concentration of formic acid	Risk phrase
>90%	R 35 causes severe burns (assuming also comparable effects on the eye)
>10% < 90%	R 34 causes severe burns (assuming also comparable effects on the eye)
>2% < 10%	R 36/38 irritant to skin and eyes

 

The harmonised classification and labelling of formic acid according to Annex I to Directive 67/548/EEC (Regulation 1272/2008/EC, Table 3.2 p.1067) is:

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

 

 

Note B :

Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and,therefore, these solutions require different classification and labelling since the hazards vary at differentconcentrations.

 

In Part 3 entries with Note B have a general designation of the following type: ‘nitric acid … %’.In this case the supplier must state the percentage concentration of the solution on the label.Unless otherwisestated, it is assumed that the percentage concentration is calculated on a weight/weight basis.

The harmonised classification and labelling of formic acid according to Regulation 1272/2008/EC, Table 3.1 p.528) is:  

Index No	International Chemical Identification	EC No	CAS No	Classification		Labelling			Specific Conc. Limits, M-factors	Notes
				Hazard Class and Category Code(s)	Hazard statement Code(s)	Pictogram, Signal Word Code(s)	Hazard statement Code(s)	Suppl. Hazard statement Code(s)
607-001-00-0	formic acid … %	200-579-1	64-18-6	Skin Corr. 1A	H314	GHS05 Dgr	H314		Skin Corr. 1A; H314: C≥90 % Skin Corr. 1B; H314: 10 %≤C< 90 % Skin Irrit. 2; H315: 2 %≤C< 10 % Eye Irrit.2; H319: 2 %≤C < 10 %	B

 

H314: Causes severe skin burns and eye damage

H315: Causes skin irritation

H318: Causes serious eye damage

H319: Causes serious eye irritation

 

 

The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid contains formic acid at concentrations up to 59% w/w. There is sufficient information available on formic acid to classify the substance for the potential to cause skin corrosion/irritation.

 

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Criteria used for interpretation of results: other: CLP Directive: EC 1272/2008 ( EU GHS)

Executive summary:

The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid contains formic acid at concentrations up to 59% w/w. On this basis, the substance meets the criteria for classification as “causes severe burns”, Risk Phrase R34 according to Directive 67/548/EEC and as CLP Category 1B “causes severe skin burns and eye damage” (GHSS05 Dgr; H314) according to the Regulation 1272/2008/EC. Further testing is not required.