Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Justification for grouping of substances and read-across

There are no data available on the skin sensitising potential of 1,3-Butylene diacetate (CAS 1117-31-3). In order to fulfil the standard information requirements set out in Annex VII, 8.3, 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 skin sensitisation.

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 sensitisation

RA CAS 623-84-7

Experimental result:

Not sensitising

(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 sensitisation

CAS 623-84-7

One study, investigating the skin sensitising properties of Propane-1,2-diyl diacetate is available. The study was conducted according to OECD 406 in compliance with GLP (Weterings, 1986). Female guinea pigs (20 in test group, 10 in control group) were induced with nine occlusive epicutaneous exposures at 25% of the test substance in propylene glycol. The epicutaneous challenge was conducted ten days after the last induction using 0.05 mL of a series of test substance concentrations (25, 5, 1 and 0% (v/v)) in propylene glycol. The negative control group was treated with the vehicle propylene glycol only. No positive control data was included in the study for reliability check.

On Day 29, a diffuse skin reddening at the skin site exposed to 25% (v/v) Propane-1,2-diyl diacetate was observed in two animals (10.5%). The complete disappearance of the observed skin reddening 24 h later might indicate that the effects were not due to sensitisation. No further skin reactions were observed.

In summary, only two animal of the treatment group (10.5%) showed a positive result for skin sensitisation and thus Propane-1,2-diyl diacetate (CAS 623-84-7) was considered to be not sensitising.

Conclusion for skin sensitisation

The structurally related source substance Propane-1,2-diyl diacetate (CAS 623-84-7) showed no skin sensitisation potential in guinea pigs.

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


Migrated from Short description of key information:
Based on read-across from Propane-1,2-diyl diacetate (CAS 623-84-7):
Skin sensitisation: not sensitising

Justification for selection of skin sensitisation 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).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 sensitisation 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.