Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Male and female fertility indices were decreased in the 200 mg/kg bw/d dose group (80% of control) to an extent slightly exceeding the limit of the historical control data (84-100%). However, histopathological correlates, which could explain infertility, were not found in the sex organs of the infertile mating pairs. For discussion of these observations, please refer to field "justification for classification or non-classification".

Based on the results of this study, the following dose descriptor was derived:

NOAEL for reproductive performance and fertility in male and female Wistar rats: 75 mg/kg bw/d

Short description of key information:
Trennmittel ZM 121 (3 -Dimethyl-aminopropyl-ölsäureamide) was administered orally via gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at doses of 0, 25, 75 and 200 mg/kg bw/d in order to observe the possible effects of the test substance on the integrity and performance of the reproductive system in both sexes.
Regarding clinical examinations, salivation was observed predominantly after treatment in both sexes of test groups 2 (75 mg/kg bw/d) and 3 (200 mg/kg bw/d). From the temporary, short appearance immediately after dosing salivation was most likely induced by a bad taste of the test substance or local affection of the upper digestive tract. This finding was not considered to be an adverse and toxicologically relevant effect. In addition, respiration sounds occurred in several animals during different phases of the study and not throughout the entire study period. This finding was also assessed as being related to treatment and possibly associated to the administration procedure. However, gross lesions were not observed during gross pathological examination.
Regarding pathology the test substance led to no pathological findings in the parental Wistar rats, but a treatment-related decrease of absolute terminal body weights in male animals of test groups 2 (75 mg/kg bw/d) and 3 (200 mg/kg bw/d) could not be excluded definitely.
A NOAEL for general, systemic toxicity of the test substance was established at 25 mg/kg bw/d for the F0 parental males based on impaired body weight data and 200 mg/kg bw/d for females

For fertility endpoints see field "discussion" under "effects on fertility". For developmental endpoints see field "discussion" under "effects on developmental toxicity".

Effects on developmental toxicity

Additional information

The viability index as indicator for pup mortality was decreased in the 200 mg/kg bw/d dose group (94%) to an extent slightly exceeding the limit of the historical control data (95-100%). However, gross necropsy of the pups revealed no relevant findings. For discussion of these observations, please refer to field "justification for classification or non-classification".

Based on these findings, the NOAEL for developmental toxicity was established 75 mg/kg bw/d for both sexes.

Justification for classification or non-classification

The low degree of exceedance of the historical control range and the lack of pathological correlates contest the relevance of the findings concerning the fertility and viability indices. The historical control data used in the study report originated from different study types, including mainly 2-generation studies with substance administration via the diet. A broader base of historical control data is meanwhile available from exclusively Reproduction/Developmental Toxicity Screening Tests (according to OECD Guidelines 421 and 422) with application via gavage, which corresponds to the design of the screening study for 3-Dimethyl-aminopropyl-ölsäureamide. These data are attached to chapter 13 of the IUCLID.
In this dataset, male and female fertility indices range between 70 and 100%. Concerning the viability indices, the majority of data lie within a range of 99-100%. A few studies, however, resulted in control group viability indices of 96-98%, and in one study a viability index of 83% was observed in the control group.
A viability index of 94% was found in the group that received the highest dose of 3-Dimethyl-aminopropyl-ölsäureamide. Although this value is lower than the majority of the more recent historical control values, the one study in which a viability index of 83% was found in the control group indicates that a more pronounced non-substance-related reduction of the viability indices occasionally occurs.

In conclusion, the newer historical control data can be considered more reliable as they cover a narrower timeframe around the conduction of the present study and reflect the same or a very similar study design. Therefore, the observed reduction of the pup viability index and the male/female fertility indices are not considered to be substance-related effects.

Based on the available data, classification according to Regulation (EC) No 1272/2008 is not warranted.

Additional information