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EC number: 203-904-5 | CAS number: 111-75-1
The atmospheric concentrations were measured online by FID and confirmed by GC analyses of absorption samples. The concentrations measured by FID are presented in table 1. GC analyses confirmed largely the values of FID measurement. Details see part II of the report.
Table 1: Study means and standard deviations of test substance concentrations measured by FID
Measured concentration (mg/m³)
Nominal concentration (mg/m³)
Effectiveness of vapor generation(%)
The vapor generation effectiveness was as expected for these high concentrations.
Measurements concerning operation conditions
The air flows were constantly maintained in the desired range. An air change of about 67 times per hour can be calculated by dividing the supply air flow through the volume of each inhalation system.
Relative humidities in the inhalation systems ranged between 39.3 and 63.8 %. In the test groups the relative humidity was slightly lower than those in the control chamber, because the test substance was sprayed by means of compressed air, which is dry. Nonetheless, all values were within the range suggested by the respective testing guidelines.
The temperatures in the inhalation systems ranged between 21.7 and 24.1°C.
On the basis of duration of use and the analytical findings with respect to chemical and microbiological contaminants the food, drinking water and bedding enrichment were found to be suitable.
When compared with control group 0 (=100%), the mean absolute weights presented in the tables 2-5 were significantly increased in one or more test groups (statistically significant changes printed in bold):
Table 2: Relative increase of absolute weights in males
* : p <= 0.05, **: p <= 0.01
Table 3: Relative increase of absolute weights in females
Table 4: Relative increase of relative weights in males
*: p <= 0.05, **: p <= 0.01
Table 5: Relative increase of relative weights in females
Weight changes in thymus, spleen and liver were regarded as incidental as no dose response relationship and/or histopathological correlates were detected.
The decrease in epididymis and testis weights was considered to be treatment-related even in the absence of a clear dose response relationship or, in the case of the testis, no changes in relative weights as there was a histopathological correlate.
All other mean absolute or relative weight parameters did not show significant differences when compared to the control group 0.
Treatment-related findings were observed in level I of larynx, and level I and II of nasal cavity, in males and females as well as in epididymis and testis in male animals with incidences and grading shown in the table below:
Treatment – related findings in the larynx were epithelial alteration characterized by slight modification of epithelial cells (i.e., three to four cell layers, focally flattened and stratified) indicating beginning metaplastic transformation and minimal to slight squamous metaplasia (characterized by three to four cell layers of flattened, stratified epithelium with no signs of keratinization and only affecting the epiglottis when graded minimal and up to five cell layers of flattened, stratified epithelium, occasionally minimal focal keratinization, with/without focal desquamation of superficial cells when graded slight). Table 6: Incidence and grading of histological findings in larynx
No. of animals
Nasal cavity, level I
The following treatment- related findings were noted in the nasal cavity:
Degeneration / regeneration of transitional and respiratory epithelium was characterized by variable vacuolation, presence of few apoptotic bodies, minimal infiltrates of inflammatory cells, increased size and basophilia of nuclei and minimal disorganization of cells.
Metaplasia, squamous was characterized by flattened epithelial cells with variably present minimal keratinization.
Table 7: Incidence and grading of histological findings in nasal cavity
Degeneration /regeneration transitional epithelium
Metaplasia, squamous, transitional epithelium
Degeneration /regeneration respiratory epithelium
Nasal cavity, level II:
One male test group 3 (225 mg/m³) animal (No 134) showed minimal degeneration / regeneration of the olfactory epithelium, in level I it showed degeneration/regeneration of the transitional epithelium)
Tubular degeneration was observed in a higher incidence in treated test groups. This finding was characterized by randomly affected (not stage specific) tubules with sloughed spermatogenic cells, vacuolation of the spermatogenic epithelium or missing germ cell layers.
Table 8: Incidence and grading of histological findings in testes
Debris in the epididimydes was characterized by sloughed spermatogenic cells and noted with increased incidence in treated animals.
Table 9: Incidence and grading of histological findings in epididymides
All other findings occurred either individually or were biologically equally distributed over control and treatment groups. They were considered to be incidental or spontaneous in origin and without any relation to treatment.
The male partner of the mating pair (Nos. 17/117), which did not produce offspring showed testicular degeneration and debris in the epididymis which might have impaired fertility even if animals with similar findings in the same group did produce offspring.
To evaluate the toxicity profile ofDibutylethanolamine(DBEA) after inhalation exposure, groups of ten male and ten female Wistar rats (F0 animals) per test group were exposed nose-only to vapours of DBEA at target concentrations of 25, 75 and 225 mg/m³ (correspond to measured concentrations 20.6, 72.1 and 236.3 mg/m³, respectively) for 6 hours per day on each day (BASF SE, 2013, Report No.87R0286/05I017, GLP, OECD 422).The duration of treatment covered a 2-week pre-mating and 2-week mating period in both sexes, 1 day post-mating in males, and the entire gestation period of the females. After the lactation period and after necropsy of the pups total all parental females were exposed to the test substance on 4 consecutive days. The total exposure amounts to 28 and 50 day in males and females, respectively.The test substance did not cause any adverse effect with regard to reproductive and developmental parameters.The male mating index was 100 % in all groups including the controls. The male fertility index ranged between 90 % and 100 % without showing any relation to exposure concentration. The female mating and fertility indices and duration of gestation were similar to controls. Implantation was not affected by the treatment since the mean number of implantation sites was comparable between all test substance-treated groups and the controls, taking normal biological variation into account. There were no statistically significant differences in post-implantation loss between the groups and the mean number of F1 pups delivered per dam remained unaffected. The rate of liveborn pups was also not affected by the test substance. The mean number of delivered F1 pups per dam and the rates of liveborn were evenly distributed about the groups. The respective values reflect the normal range of biological variation inherent in the strain used in this study.The viability index and sex ration of pups did not show any association to the treatment. There were no test substance related adverse clinical signs observed in any of surviving F1 generation pups of the different test groups. No test compound-related influence on F1 pup body weights and pup body weight change were noted in all test groups.No findings were observed at gross necropsy in any male or female pups of all test groups.Systemic toxicity effects were only transiently reduced food consumption, body weight and body weight gain in parental animals. In their histopathology, lesions of nasal epithelia were observed in animals exposed to 72.1 and 236.3 mg/m³ test substance. Thus, concerning systemic toxicity, reproductive and developmental parameters the NOAEC for 2-dibutylaminoethanol was determined to be 236.3 mg/m³ for male and female animals. Considering histopathological changes, the NOAEC for local effects was 20.6 mg/m³.
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