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Description of key information

Oral: Subacute Toxicity Study 28days, oral, rat, OECD 422, up to 400mg/kg bw/day tested: LOAEL >= 50mg/kg bw/d (BASF SE, 2013, 85R0674/12X380). Specific target organ toxicity: heart (cardiomyopathy) for read across substance Amines, tri-C8-10-alkyl.

Dermal: No data available

Inhalation: No data available

Key value for chemical safety assessment

Additional information

There is no data available for tridodecylamine. A suitable read across candidate for which data is available isAmines, tri-C8 -10 -alkyl (CAS # 68814 -95 -9):

Studies according to OECD guidelines:

A study investigating the toxicological effects of the test item Amines, tri-C8-10-alkyl to rats according to OECD guideline 422 resulting from repeated oral-gavage administration is performed (BASF SE, 2013, 85R0674/12X380). Amines, tri-C8-10-alkyl was administered in corn oil as vehicle at dosages of 50, 150 and 400 mg/kg body weight/day, and controls received the vehicle only. Amines, tri-C8-10-alkyl was administered to male rats for 43 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 postpartum.

All animals survived until scheduled necropsy. There were no test item related clinical signs in both genders at 50 mg/kg bw/day. At 150 mg/kg bw/day, no signs of discomfort were observed; food consumption and body weights were similar to controls. A reduction in food consumption and body weight was noted in males and females at 400 mg/kg bw/day when compared with controls. Furthermore, higher values of aspartate aminotransferase, alanine aminotransferase and of alkaline phosphatase were noted in both genders at 400 mg/kg bw/day, without a histopathological correlate in the liver.

At a dose level of 150 and 4000 mg/kg bw/day, no female gave birth. Females had only implantation sites (minority of females) or embryonic resorptions (majority of the females). At 50 mg/kg bw/day, a higher mean incidence of post-implantation loss was noted, which was not statistically significantly different compared to the control group but out of the range of historical control data. Due to the total post implantation loss at 150 and 400 mg/kg bw/day, it cannot be excluded, that this was a test-item-related effect.

In males, reduced testes and epididymides weights were noted at 400 mg/kg bw/day.Microscopically, minimal to moderate increase in the formation of the residual bodies ofabnormal shape and size was observed in the testes at 150 and 400 mg/kg bw/day. In the epididymides, the exfoliated residual bodies (cell debri) were noted at 400 mg/kg bw/day.

 In all treatment groups (50, 150 and 400 mg/kg bw/day), cardiomyopathy was noted in the heart, and foamy macrophages accumulation was observed in the lungs. The males showed higher incidence and severity than the females, respectively.

 

Based on these results, no NOAEL (No Observed Adverse Effect Level) could be established for general toxicity and reproduction in this study. Nevertheless, according to the applicant a LOAEL of 50 mg/kg bw/d based on cardiomyopathy in males is established and used for calculation. As the effects observed show a dose reponse it is assumed that the effects decrease to a normal range (compareable to the controls, based on the trend observed from 400 to 50 mg/kg bw/d) when lowering the dosage to 5 mg/kg bw. To adress this assumption in Risk assessment a factor for LOAEL to NOAEL conversion of 10 is added.

Furthermore these assumption is used for the classification of the substance.

 

Based on the result presented above, no NOAEL could be established for general toxicity in this study.

The LOAEL was 50mg/kg bw/kg, which was the lowest concentration tested and a dose response correlation was observed by the leading effects (cardiomyopathy). Due to the trend in dose response it is assumed that these effects observed may be decreased if the dose will be reduced to 5 mg/kg bw/d. Therefore this worst case value is used as threshold for classification.

Justification for classification or non-classification

Based on the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the substance has therefore labeled as:

 

GHS: STOT RE 1, H372: Causes damage to organs (heart) through prolonged or repeated exposure if swallowed.

DSD: T, R48/25 Toxic: danger of serious damage to health by prolonged exposure if swallowed.