Formic acid, manufacture of, by-products from

Eye irritation

Administrative data

Endpoint:

eye 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

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

There are no valid studies with respect to the eye irritation of formic acid. However, according to OECD TG 405 (adopted 24^thApril 2002) corrosivity to the eyes is assumed based on the following:

1. Formic acid fulfils the criteria for a caustic compound (pH<2). In this case the OECD guideline assumes corrosivity to the eyes.

2. Formic acid is classified as corrosive to the skin (causes severe burns, R35) according to EU criteria. OECD TG 405 concludes that a similar effect (corrosivity) is expected for the eyes and that no testing is needed

3. Similarly, the potential to cause severe eye lesions is assumed for skin corrosive substances in Directive 67/548/EEC and Regulation 1272/2008/EC

Formulations or preparations containing formic acid, can be classified based on the published specific concentration limits. No caustic effect is assumed for preparations with concentrations of formic acid below 10%, which should be labelled as irritant to the eye (R 36).

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

 

 On this basis, since the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid contains formic acid at concentrations > 10%, classification for eye irritation is not appropaite: the substance is considered to be corrosive and is classified 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.

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) 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 which exceeds the 10% limit considered for causticity. On this basis, the substance is considered to be caustic and expected to cause more severe eye damage than irritation. The substances 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 in respect of eye irritation is not required.