Ethanol, 2,2'-oxybis-, 1,1'-diformate

Endpoint summary

Description of key information

Based on read-across from Ethylene diformate (CAS 629-15-2):

OECD 431: H314, Skin Corrosion 1B

eye irritation: consequent classification due to skin corrosion, H318, Serious Eye Damage 1

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for grouping of substances and read-across

Annex VII of the REACH Regulation includes a requirement for in chemico/in vitro tests as a first step for addressing skin and eye irriation (section 8.1.1 and 8.2.1). Only in the case that the in chemico/in vitro methods are not applicable for the substance, or the results are not adequate for classification and risk assessment, in vivo skin and eye irritation can be performed (section 8.1 and 8.2 Annex VIII). There are no data available on the skin and eye irritating potential of Diethyleneglycol diformate (CAS 120570-77-6), either both in vitro and in vivo.

Therefore, in vitro studies should be first considered to fulfill the information requirements. However, certain steps need to take place before any testing (in vitro or in vivo) is conducted as described in the introductory paragraph to Annex VII, i.e. assessment of all available information, which among other suggest to consider data from structurally related substances (read-across approach in accordance with Annex XI, 1.5).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity, Ethylene diformate (CAS 629-15-2) is selected as reference substance for assessment of skin and eye irritation/corrosion (see read across jusitification).

The substance was tested following OECD 431 in 2012 and under the experimental conditions showed a skin corrosive potential as H314 Skin Corrosion Cat 1B.

Overview of skin irritation properties

CAS#	120570-77-6 (a)	62-15-2 (b)
Chemical name	Diethyleneglycol diformate	Ethylene diformate
Molecular weight	162.14	118.09
Skin irritation/corrosion	RA: CAS 629-15-2	Corrosive (in vitro)

(a) The substance subject to the REACh Phase-in registration deadline of 31 May 2013 is indicated in bold font. Only for this substance a full set of experimental results and/or read-across is given.

(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

In vivo skin irritation / corrosion

This information is not available.

Based on read-across and the available in vitro data from the analogue substance Ethylene diformate, the substance fulfils the criteria for classification as skin corrosive (Category 1B) according to Regulation (EC) No 1272/2008. Therefore, an in vivo skin irritation study does not need to be conducted in accordance with Column 2 of Annex VIII, Section 8.1, of Regulation (EC) No 1907/2006.

 

In vivo eye irritation / corrosion

The substance is classified as skin corrosion, leading to a classification as serious eye damage (H318, Category 1), therefore following the specific rules for adapatation of the information requirements as set out in Column 2 of Annex VII, Section 8.2 of the REACH Regulation (EC) No 1907/2006, the in-vitro and the in vivo eye irritation/corrosion studies does not need to be conducted.

Supportive documentation to the classification is reported in a WoE approach by reading across from Ethylene diformate (CAS 629-15-2)

Justification for classification or non-classification

Based on read-across from a structurally related substance and following an analogue approach, the available data on the skin and eye irritating/corrosive potential of Diethyleneglycol diformate meet the classification criteria for Skin Corrosive Category 1B (H314: Causes severe skin burns and eye damage) and Irreversible Eye Damage Category 1 (H318: causes serious eye damage) according to Regulation (EC) 1272/2008.