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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 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.

 

 

Target Substance

Source Substance 1

Source Substance 2

Source Substance 3

 

N,N-Dimethyldodecan-amide

N,N-Dimethyldecan-amide

N,N-Dimethyloctanamide

Mixture of N,N-Dimethyloctanamide and N,N-Dimethyldecanamide

CAS

3007-53-2

14433-76-2

1118-92-9

67359-57-3

Skin sensitization

RA to 67359-57-3

RA to 67359-57-3

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 is anticipated.

In summary no skin sensitization is expected for the target substance.

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)


Migrated from Short description of key information:
Guinea Pig (Buehler): RA to mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide; not sensitising (Stepan 1990, J.J Kreuzmann)

Justification for selection of skin sensitisation endpoint:
Most adequat reliable result, see discussion.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
no information available

Justification for classification or non-classification

Skin sensitisation:

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).

Respiratory sensitisation:

There are no data available for a classification as a sensitizer to respiratory system.

Labelling skin/respiratory sensitisation:

GHS: no classification

DSD: no classification