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EC number: 221-117-5
CAS number: 3007-53-2
Justification for grouping of substances and read-across
There are no reliable data available for skin sensitization of
N,N-Dimethyldodecan-amide (CAS 3007-53-2). In order to fulfil the
standard information requirements set out in Annex VIII, 8.5, 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 substances may be predicted as similar provided
that their physicochemical, toxicological and ecotoxicological
properties are likely to be similar or follow a regular pattern as a
result of structural similarity, the substance listed below are selected
as reference substances for hazard assessment.
Source Substance 1
Source Substance 2
Source Substance 3
Mixture of N,N-Dimethyloctanamide and N,N-Dimethyldecanamide
RA to 67359-57-3
OECD 406, not sensitizing (Stepan, 1990)
The above mentioned substances are considered to be similar on the
basis of structural similarity resulting in similar properties and/or
activities. The available endpoint information is used to predict the
same endpoints for N,N-Dimethyldodecan-amide (CAS 3007-53-2). A detailed
analogue approach justification is provided in the technical dossier
(see IUCLID Section 13).
Mixture of dimethylamides (CAS 67359-57-3)
A test with a mixture of N,N-dimethyldecanamide and
N,N-dimethyloctanamide for skin sensitisation was done using an
adaptation of the method of Ritz and Buehler* (Stepan 1990, J.J
Kreuzmann).The test substance was used as 5% w/v formulation in 80%
ethanol/20% distilled water for induction and as 2.5% formulation in
acetone for challenge and epicutanueous occlusive applied to 20 guinea
pig. There were no grades of 1 produced in the test or control animals.
The incidence of grade + responses in the test group (14 of 20) was
compared to that of the naive control group (7 of 10). The incidence and
severity of these responses in the test group were essentially
comparable to those produced by the naive control group indicating that
sensitization had not been induced. Therefore the mixture was classified
as not sensitising!
Due to the fact that a high amount in the mixture was
N,N-dimethyldecanamide and the rest of the mixture are homologues with a
lower and higher molecular weight which can be assumed to have an
similar toxicological behaviour it is concluded by the registrant that
also pure N,N-dimethyldodecaneamide has no sensitising potential. This
is underlined by the identical behavior or trend in toxicity observed
for other toxicological endpoints. Further source and target substances
contained the same structure elements (carbon acid dimethyl amide). As
major key events of skin sensitization are triggered by specific
structure elements of the substance and no structure element change from
source to target substance same behavior concerning skin sensitization
In summary no skin sensitization is expected for the target
Hence, taking reliability, adequacy and availability into account,
the following information on skin sensitisation is used for assessment:
Guinea Pig (Buehler): RA to mixture of N,N-dimethyldecanamide and
N,N-dimethyloctanamide; not sensitising (Stepan 1990, J.J Kreuzmann)
Skin sensitisation was investigated in a skin sensitisation guinea
pig study (buehler protocol; mixture of dimethylamides): The scores
obtained from the study led to no classification for skin sensitisation
according to GHS (Regulation (EU) 1272/2008) and also to no
classification according to EU-criteria DSD (67/548/EEC).
There are no data available for a classification as a sensitizer
to respiratory system.
Labelling skin/respiratory sensitisation:
GHS: no classification
DSD: no classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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