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 for on the skin sensitisation potential of the substance 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS# 93803-89-5). 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 structurally related substances was 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 toxicological properties may be predicted from data for the reference substance(s) on the basis of structural similarity, the substances listed below are selected as reference substances for assessment of toxicological endpoints, for which information gaps are identified.

Overview of skin sensitisation

CAS

Skin Sensitization

93803-89-5(a)

RA: CAS 131459-39-7

131459-39-7(b)

Not sensitizing

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

(b)  Substances that are either already registered under REACh or not subject to the REACh  Phase-in registration deadline of 31 May 2013 are indicated in normal font.

 

The above mentioned substances are considered to be similar on the basis of the structural and similar properties and/or activities. The available endpoint information is used to predict 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS# 93803-89-5).

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Discussion

 

Since no studies investigating the sensitisation of of2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate(CAS 93803-89-5) are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5, a read-across from the structurally related analogue 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) was conducted.

 

CAS 131459-39-7

A Guinea Pig Maximisation Test was performed with 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS# 131459-39-7) according to OECD Guideline 406 (Allen, 1999). 10 male Dunkin-Hartley guinea pigs were treated with the test substance and compared with 4 negative control animals. The sensitivity of the animal strain was periodically tested using PEG 400 70:30 in acetone as positive control substance. A 25% dilution of the test substance in arachis oil was used for intradermal induction and 100% used for epidermal induction. 14 days after the last induction treatment, all animals were challenged epicutaneously with the 75% and 100% test substance. 24 and 48 hours after challenge exposure all skin examination scores were zero in all test animals and negative control animals. Based on the study results no classification is required according to EU classification criteria for skin sensitisation.

Taken together, all available experimental data did show no skin sensitisation potential.

 

Conclusion for skin sensitization

1 GPMT has been conducted with3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7).There is no evidence for a skin sensitizing potential in this assay. Therefore2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate(CAS 93803-89-5)is not considered to have skin sensitizing potential.


Migrated from Short description of key information:
Skin sensitisation (OECD 406): 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
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

Based on read-across from the structurally similar substances, the available data on skin sensitization do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification