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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
45 mg/kg bw/day
Additional information

As there is not data on fertility available for di-tridecamine, read-across from tridecylamine (TDA) is performed. There is no specific fertility study with TDA available. TDA was tested under GLP conditions in a 90 day oral gavage study according to OECD TG 408 in male and female Wistar rats (BASF AG, 2004; Val. 2). The tested dose levels were 5, 15, and 45 mg/kg bw/day. Additionally to the requirements of OECD TG 408, the effects on the male and female reproductive organs were examined in this study in terms of absolute and relative weight changes, histopathological, and functional changes of the male and female reproductive organs. Sperm parameters were determined on all animals with respect to sperm motility, sperm morphology, sperm head count (cauda epididymidis and testis). Estrous cycle was determined in all females from day 63 to 91.

 

No weight changes were seen in the reproductive organs apart from a significantly decreased absolute weight of the testes. As this effect was only found in the mid-dose group, and not in the high-dose animals, it was considered to be not related to the administration of the test substance. This also holds true for the prolonged estrous cycle of the mid-dose females. As there was no dose relation observed, this finding was also considered not to be related to the treatment with Tridecylamine. Sperm parameters were unchanged compared to controls. Thus, the NOAEL for the examined fertility parameters in males and females was 45 mg/kg bw/day, the highest dose tested.


Short description of key information:
NOAEL: fertility parameters from a OECD TG 408 study: 45 mg/kg bw/day (male/female).

Effects on developmental toxicity

Description of key information
NOAEL: developmental toxicity: 20 mg/kg bw/day (OECD TG 414)
NOAEL: maternal toxicity: 20 mg/kg bw/day (OECD TG 414)
NOAEL: teratogenicity: >= 80 mg/kg bw/day (OECD TG 414)
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
20 mg/kg bw/day
Additional information

As there is no data on developmental toxicity available for di-tridecamine, read-across from tridecylamine (TDA) was performed. TDA was examined in a GLP developmental/teratogenicity study according to OECD TG 414 using pregnant female Wistar rats (BASF AG, 2003; Val. 1). Groups of 25 animals received dose levels of 0, 5, 20, or 80 mg/kg bw/day during days 6 through 19 of gestation (post coitum). The dams of the high dose group showed signs of toxicity as substantiated by a statistically significant impaired bodyweight gain and a corrected terminal body weight gain lowered by 21 %. No significant clinical sign was noted in the other dose groups.

 

At scheduled necropsy, 22-24 animals/group had implantation sites. The conception rates reached 92 % in all treated groups and were somewhat lower than in the control group (100 %); this small decrease is not considered to be of any biological relevance. There were also no substance-related or biologically relevant differences between the groups with regard to mean number of corpora lutea and implantation sites, pre- and post-implantation losses, or the numbers of resorptions or viable fetuses.

 

The fetal weight and sex distribution was unchanged by the treatment. The occurrence of external malformations, skeletal and soft tissue malformations was comparable between the control and the treated test groups. A statistically significant increased incidence of some skeletal variations was, however, seen in fetuses from the high-dose females. The described findings are considered as skeletal variations because they also occur spontaneously in the strain of rats used and because they reflect a transient effect that is fully reversible postnatally. These were characterized as general delays in skeletal ossification (9.2 % fetuses/litter vs. 0 % in controls); incomplete ossification of supraoccipital (28.6 % fetuses/litter vs. 16.5 % in controls); bipartite ossification of the thoracic centrum (4.2 % fetuses/litter vs. 0 % in controls); incomplete ossification of the sacral arch (57.4 % fetuses/litter vs. 25.7 % in controls). The overall incidence of skeletal variations was not different from historical control data.

 

There were no signs of teratogenicity noted at any dose level. In summary, there were slight indications of substance-induced effects on skeletal maturation without effects on fetal weight at a maternally toxic dose of 80 mg/kg bw/day. Gestational parameters were unaffected up to and including 80 mg/kg bw/day. Fetal parameters were unaffected at all dose levels except the increased occurrence of transient delays in the ossification of the skull and the ventral column in the high dose group. The overall incidence of skeletal variations was not different from historical control data.

 

The NOAEL for maternal toxicity and for prenatal development was 20 mg/kg bw/day in this study. There was no sign of teratogenicity at the highest tested dose of 80 mg/kg bw/day.

Justification for classification or non-classification

Based on the available information information on the read-across substance tridecylamine, di-tridecamine does not need to be classified for reproduction toxicity according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.