Registration Dossier

Administrative data

Description of key information

Based on read-across from Propane-1,2-diyl diacetate (CAS 623-84-7):
Skin: not irritating
Eye: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for grouping of substances and read-across

There are no sufficient data available on the eye irritating potential of 1,3-Butylene diacetate (CAS 1117-31-3). In order to fulfil the standard information requirements set out in Annex VIII, 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

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, Propane-1,2-diyl diacetate (CAS 623-84-7) is selected as reference substance for assessment of eye irritation.

The read-across is based on the structural similarity between the source and target substances which are all esters of similar di-functional alcohols with the carboxylic acid acetic acid. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Overview of irritation / corrosion

CAS#

1117-31-3 (a)

623-84-7 (b)

Chemical name

1,3-Butylene diacetate

Propane-1,2-diyl diacetate

Molecular weight

174.20 g/mol

160.17 g/mol

Skin irritation

Waiving

 Experimental result:

Not irritating

Eye irritation

RA CAS 623-84-7

Experimental result:

Not irritating

(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 “--“.

 

Skin irritation/corrosion

CAS 623 -84 -7

A non-GLP skin irritation study is available for the structurally related substance Propane-1,2-diyl diacetate, in which 0.01 mL of the undiluted test substance was applied to the shaved bellies of 5 rabbits for a period of 24 h under open conditions (Union Carbide Corporation, 1965). No skin irritation was observed up to 24 h after exposure. However, only a tenth of the dose used according to OECD guideline 404 was applied and no scoring of skin reaction was performed. Therefore, the study did not meet important criteria of today standard methods and was thus not taken into account for hazard assessment.

However, the available study on acute dermal toxicity from the read-across source substance Propane-1,2-diyl diacetate (CAS 623-84-7) does not indicate skin irritation or corrosion up to the limit dose level (see Acute toxicity). Therefore, based on read-across, an in vivo skin irritation study does not need to be conducted according to Column 2 of Annex VIII, Section 8.1.1, of Regulation (EC) No 1907/2006, and the substance is thus considered to be not irritating.

Eye irritation/corrosion

CAS 623-84-7

The eye irritation properties of Propane-1,2-diyl diacetate were tested in a study according to OECD guideline 405 under GLP conditions (Dow, 1994). In a group of 3 female rabbits (New Zealand White), 0.1 mL of the undiluted test substance was applied into one eye. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h after application.

No effects on cornea, iris and no conjunctival redness were observed in any animal during the study period. No further local or systemic effects were reported.

Under the experimental conditions described, it was concluded, that no evidence of eye irritation properties were seen after treatment with Propane-1,2-diyl diacetate.

Conclusion for skin and eye irritation

In conclusion, 1,3-Butylene diacetate (CAS 1117-31-3) is considered to be not irritating to the skin based on read-across data for acute dermal toxicity (see Acute toxicity). One study from the structurally related source substance Propane-1,2-diyl diacetate (CAS 623-84-7) did not show eye irritation properties.

Based on this result, no skin or eye irritation potential for 1,3-Butylene diacetate (CAS 1117-31-3) was identified.


Justification for selection of skin irritation / corrosion endpoint:
No study selected, since hazard assessment is conducted by means of read-across from an acute dermal toxicity study with a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

Based on read-across from the source substance Propane-1,2-diyl diacetate (CAS 623-84-7) following an analogue approach, the available data on skin and eye irritation properties of 1,3-Butylene diacetate (CAS 1117 -31 -1) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.