Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, dioleates

Toxicity to reproduction

Administrative data

Endpoint:

toxicity to reproduction

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Executive summary:

Cross-reading between from Oleyl-diamine dioleate to Tallow-diamine dioleate is acceptable on the basis of identical chemical structures. The only differences between the two substances are related to the alkyl-chains linked to the diamine. Contrary to oleyl do tallow-alkyl chains also contain some C16-chains next to the C18-alkyl chains. The toxicological relevance of this difference is expected to be negligible. The higher level of unsaturation in oleyl-alkyl chains compared to tallow-alkyl chains can be considered a worst case representation with respect to possible toxicity when compared to tallow-alkyl chains, related to a probably marginal higher solubility. Due to this very great similarity between these two substances, results obtained from Oleyl-diamine dioleate are fully applicable for the evaluation of Tallow-diamine dioleate as well

 

Oleyl-diamine dioleate and Tallow-diamine dioleate are salts of an alkyl-diamine and oleic acid, in a molar ratio of 1:2. Absorption and subsequent possible toxicity follows the dissociation of the salt. The diamine structure is much more toxic than the oleic acid part, and therefore it is considered that toxicity profile of alkyl-diamine dioleate will be fully driven by its alkyl-diamine content.

 

The available repeated dose data allows for the comparison of a 28-day study on Oleyl-diamine dioleate with an available 28-day study on Oleyl-diamine done at a different time in a different lab. The outcome of both studies show an almost exact match between the two observed toxicity profiles and levels when based on Oleyl-diamine content. This demonstrates that the toxicity of the alkyl-diamine dioleate salts is indeed driven by their alkyl-diamine content. For further evaluation of toxicity of alkyll-diamine dioleate, including reproduction toxicity, therefore cross-reading can be done to the data available on alkyl-diamine.

 

No adverse effects on reproductive organs were identified in the 28-day study on Oleyl-diamine dioleate itself nor in the various studies available on Oleyl-diamine and C12-14-diamine, including the 90-day study on C12-14-diamine. In accordance with Section 8.7.3 of column 1, Annex IX of REACH, no further two-generation reproduction study is therefore indicated.

A developmental toxicity study performed on Oleyl-diamine also included endpoints relevant to assessing an effect on fertility. No effects on pre/post implantation rate, late/early resorptions, corpora lutea or number of live fetuses were seen in this study. Although the available data on Oleyl-diamine does not include information on sperm parameters and oestrus cycle, there are currently no indications of an effect of alkyl-diamines on fertility.

 

AlsoOleyl-diamine3EO (ethoxylated Oleyl-diamine, with three ethoxyl groups)has been shown to havea comparable toxicological profileas the non-ethoxylated Oleyl-diamine, and an available reproduction screening study (OECD 422) on Oleyl-diamine3EO (not in this dossier) has additionally shown no concerns for reproduction up to the highest level tested.

 

All the data on Oleyl-diamine dioleate is also applicable for the evaluation of Tallow-diamine dioleate.

 

Tallow-diamine dioleate is a solid at 20°C with a melting point of 38 °C. It has avapour pressure less than 0.0015 Pa at 20°C (value is an overestimation as it is based on read-across from C12-14-diaminerather than a dioleic acid salt of an alkyl diamine as Tallow-diamine dioleate salt)and the indicated use patterns also does not give rise to a high concern for specific exposures via inhalation.

Furthermore, Tallow-diamine dioleate is irritating to the skin and tallow-diamine part is not expected to easily pass the skinfrom the dioleate salt form, inview of its ionised form at physiological conditions.

Manufacture and use are highly controlled. Its use is limited to industrial and professional users where its irritating properties will ensure sufficient protection measures to prevent dermal exposure.

Considering the lack of concern for effects on fertility from available studies and the low likelihood of exposure to industrial/professional; users, further studies are not indicated.