Registration Dossier
Registration Dossier
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EC number: 701-052-3 | CAS number: 146987-98-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
For the assessment of the sensitization potential of Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] a guinea pig maximization test conducted with the closely related source substance Amides, C6-18 even numbered, N-[3-(dimethylamino)propyl] is available. A justification for read-across is given in IUCLID section 13.
In a sensitization study with Amides, C6-C18, N-[3-(dimethylamino)propyl] (a.i. 98.4%) in sesame oil, young adult Dunkin Hartley guinea pig were tested using the maximization test method according to OECD Guideline 406, 17 July, 1992 and EU Method B.6, 30 May 2008.
The maximum compatible doses which led to slight irritation after intradermal and dermal application as well as the subirritative dose for the challenge were determined in a pilot experiment. Sesame oil was used as vehicle during induction and challenge. Based on the results of the pilot study, for the intradermal and epicutaneous induction procedure test substance concentrations of 0.05 % and 5 % were used, respectively. The test article concentration for the challenge procedure was 1 %. In the challenge visible changes of the skin like slight and easily detectable erythema (= grading 1 and 2) and slight to easily recognizable swelling (= grading 1 and 2) were observed in five out of ten test group animals 24 h after patch removal; 48 h after the challenge these skin reactions were still observed and one additional animal showed slight erythema (= grading 1). The five control animals were free of skin reactions. Thus, the sensitization rate was 60 %. In the remaining four test group animals and in all control group animals no visible skin reactions were noted at any time (= grading 0).
In this study the test substance has to be regarded as sensitizing under the applied test conditions when exposed to the skin of experimental animals.
Migrated from Short description of key information:
Sensitizing; Guinea pig maximization test (OECD TG 406, GLP, RL1): intradermal induction: 0.05%, epicutaneous induction 5%; challenge: 1%; sensitisation rate: 60%; read-across: Amides, C6-C18, N-[3-(dimethylamino)propyl] (a.i. 98.4%) in sesame oil
Justification for selection of skin sensitisation endpoint:
read-across from guideline study, GLP
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on relevant, reliable and adequate data Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] is classified as Category 1A (H317: May cause an allergic skin reaction) according to regulation (EC) 1272/2008.
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