Reaction mass of ethoxylated N-oleyl-1,3-propanediamine, hydrofluorides of and ethoxylated N-palmityl-1,3-propanediamine, hydrofluorides of and ethoxylated N-stearyl-1,3-propanediamine, hydrofluorides of and olaflur

Endpoint summary

Description of key information

As no experimental determination with Olaflur was available, instead study results obtained with Oleaflur and Ethanol, 2,2`-[[3-(2-hydroxyethyl)amino]propyl]imino]bis-N-tallow alkyl derivs. are presented here using the read-across approach. Oleaflur is a structure analogue (a similar aminethoxylated fluor salt), Ethanol, 2,2`-[[3-(2-hydroxyethyl)amino]propyl]imino]bis-N-tallow alkyl derivs. the free amine base of the fluoride salt (= Olaflur). The toxicological profile of Olaflur is almost identical to Oleaflur and the free amine represents a worst case scenario with regard to skin penetration compared to the fluoride salt (= Olaflur). Under the present test conditions neither Oleaflur nor Ethanol, 2,2`-[[3-(2-hydroxyethyl)amino]propyl]imino]bis-N-tallow alkyl derivs. did show any sensitising properties in guinea pigs in a test model according to Magnusson and Kligman following OECD guideline 406 resp. EU method B.6.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Read across to Olaflur:

In the key study, Ethanol, 2,2`-[[3-(2-hydroxyethyl)amino]propyl]imino]bis-N-tallow alkyl derivs. was tested in thirty guinea pigs according to the maximization method of Magnusson and Kligman, EU-method B.6 resp. OECD guideline 406. Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. No clinical signs of systemic toxicity and no deaths related to treatment were noted during the study.

After the challenge application, no cutaneous reactions were observed in the animals of the control group.

In the treated group, at the 24-hour reading, a discrete erythema was noted in 5/19 animals (~ 25%). At the 48-hour reading, a discrete or moderate erythema was recorded in 3/19 and 2/19 animals, respectively. The full cycle induction as follows: intradermal: 0.1% (w/w), cutaneous: 25 % (w/w), challenge: 5 % (w/w). Dryness of the skin, which masked the evaluation of the erythema in one animal, was also observed in 5/19 animals at the 48-hour reading. The cutaneous reactions observed at the 48-hour reading in 5/19 animals of the treated group were attributed to delayed contact hypersensitivity.

Ethanol, 2,2`-[[3-(2-hydroxyethyl)amino]propyl]imino]bis-N-tallow alkyl derivs. induces delayed contact hypersensitivity in 5/19 guinea pigs and therefore should be considered as a mild sensitizier. However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be considered as a skin sensitizer.

In the supporting study, the concentration of Oleaflur chosen for the first (intracutaneous) induction stage, a 0.1 % suspension in sesame oil, caused slight irritation in all animals. The second (topical) induction stage with a 5 % suspension in sesame oil revealed slight, well-defined or moderate irritation in all animals. The challenge with a 0.1 % suspension in sesame oil – the maximum subirritating concentration to the depilated skin - showed no sensitising properties.

Justification for classification or non-classification

Based on the results obtained in the studies with the free amine base of the fluoride salt (= Olaflur) DINORAMOX S3 resp. the structure analogue Oleaflur, sensitising properties of both DINORAMOX S3 and Oleaflur, and consequently of Olaflur can be excluded.

Consequently, Olaflur does not have to be classified and labelled with regard to sensitisation according to Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC (DSD).