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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via inhalation route
Dose descriptor:
NOAEC
40 mg/m³
Effect on fertility: via dermal route
Dose descriptor:
NOAEL
175 mg/kg bw/day
Additional information

In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD 422 (BASF SE, 2010) 2-(2-Aminoethoxy)ethanol was administered via inhalation (aerosol) to groups of 10 male and 10 female Wistar rats (F0 animals) at concentrations of 4, 16, and 40 mg/m³.

For all F0 parental males, which were placed with females to generate F1 pups, copulation was confirmed. Thus, the male mating index was 100% in all test groups (0, 4, 16 and 40 mg/m³). Fertility was proven for most of the F0 parental males within the scheduled mating interval for F1 litter. One male of the 4 mg/m³ test group did not generate F1 pups. The apparently infertile male rat did not show histopathological findings that could explain infertility. Thus, the male fertility index was 90% in the 4 mg/m³ test group and 100% in all remaining groups including the control. This reflected the normal range of biological variation inherent in the strain of rats used for this study. All respective values were within the range of the historical control data of the test facility. The female mating index calculated after the mating period for F1 litter was 100% in all test groups (0, 4, 16 and 40 mg/m³). The mean duration until sperm was detected (GD 0) amounted to 3.1, 3.1, 2.7 and 3.3 days (0, 4, 16 and 40 mg/m³). All sperm positive rats delivered pups or had implants in utero with the exception of one low-dose female, that did not become pregnant. The female fertility index varied between 90% (4 mg/m³) and 100% (all other test groups). These values reflect the normal range of biological variation inherent in the strain of rats used for this study. All respective values were within the range of the historical control data of the test facility and did not show any relation to dosing. There were no corroborative histopathological findings in the sexual organs of the nonpregnant female rat. The mean duration of gestation values varied between 22.0 (test groups 4 and 16 mg/m³) and 22.2 days (test groups 0 and 40 mg/m³) without any relation to dosing. The gestation index was 100% in all test groups including the control. 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 (10.6, 11.1, 12.3 and 11.4 implants per dam at 0, 4, 16 and 40 mg/m³, respectively). Furthermore, there were no indications for test substance-induced intrauterine embryo-/fetolethality since the postimplantation loss did not show any significant differences between the test groups, and the mean number of F1 pups delivered per dam remained unaffected (9.3, 10.1, 11.6 and 10.7 pups per dam at 0, 4, 16 and 40 mg/m³, respectively). The rate of liveborn pups was not affected by the test substance, as indicated by live birth indices of 97% (test group 16 mg/m³) and 100% (all other test groups). Moreover, the number of stillborn pups was comparable between the test groups.

Thus, the NOAEC for reproductive performance and fertility in male and female Wistar rats was 40 mg/m³.

In a subchronic dermal study following OECD test guideline 411 (Huntsman, 2002) no effects on the male and female reproductive organs were observed up to the highest dose tested (175 mg/kg/day). Application of the test substance to an intact cutaneous site for approximately 6 hours, once daily for 90 consecutive days resulted in ulceration, epidermal hyperplasia, fibrosis and inflammation at doses of 87 and 175 mg/kg bw/d. These changes represent local irritation following topical administration. Based on the results of the study, the NOAEL for local effects was at least 17 mg/kg bw/d while the systemic NOAEL was at least 175 mg/kg bw/d.


Short description of key information:
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test the no observed adverse effect concentration (NOAEC) for reproductive performance and fertility in male and female Wistar rats was 40 mg/m³ (aerosol). The NOAEC for local signs of toxicity in male and female Wistar rats was 4 mg/m³.
In a subchronic dermal study following OECD test guideline 411 no effects on the male and female reproductive organs were observed up to the highest dose tested (175 mg/kg/day).

Effects on developmental toxicity

Description of key information
In an inhalatory (aerosol) combined repeated dose toxicity study with the reproduction/developmental toxicity screening test the no observed adverse effect concentration (NOAEC) for developmental toxicity in male and female Wistar rats was 40 mg/m³. The NOAEC for local signs of toxicity in male and female Wistar rats was 4 mg/m³.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
40 mg/m³
Additional information

In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD 422 (BASF SE, 2010) 2-(2-Aminoethoxy)ethanol was administered via inhalation (aerosol) to groups of 10 male and 10 female Wistar rats (F0 animals) at concentrations of 4, 16, and 40 mg/m³.

The mean number of delivered pups per dam and the rate of liveborn and stillborn pups were evenly distributed among the test groups (control, 4, 16 and 40 mg/m³). The respective values reflect the normal range of biological variation inherent in the strain used in this study. The viability index as indicator for pup mortality between PND 0-4 varied between 99% and 100% in all test groups. The sex distribution and sex ratios of live F1 pups on the day of birth and on PND 4 did not show biologically relevant differences between the test groups. The F1 pups did not show any test substance-induced or spontaneous clinical signs up to scheduled sacrifice on PND 4. Mean pup body weights and pup body weight changes of all test substance-treated groups were generally comparable to the concurrent control group throughout the lactation period. Some F1 pups showed spontaneous findings at necropsy, such as post mortem autolysis, aneurysm of ductus arteriosus, short innominate, empty stomach and hemorrhagic testis. These pup necropsy findings occurred without relation to dosing and/or can be found in the historical control data at comparable or even higher incidences. Therefore, these findings were not considered to be associated to the test substance. Thus, the NOAEC for developmental toxicity was 40 mg/m3.

Justification for classification or non-classification

Classification for toxicity to reproduction is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.