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Description of key information

Subchronic dermal and subacute inhalative data are available for the determination of the repeated dose toxicity.
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test the no observed adverse effect concentration (NOAEC) for general systemic toxicity as well as reproductive performance, fertility and 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.
In a subchronic dermal study following OECD test guideline 411 dermal irritation was noted at the lowest dose tested (17 mg/kg/day). The NOAEL for systemic toxicity was determined to be 175 mg/kg/day (highest dose tested).

Key value for chemical safety assessment

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
4 mg/m³
Study duration:
subacute
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
175 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

In a subchronic dermal study following OECD test guideline 411 (Huntsman, 2002) 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.

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. Regarding clinical examinations, no signs of general systemic toxicity were observed in male and female parental animals at any dose level during the entire study period. Fertility indices for male and female animals were not impaired by test-substance administration even at a dose level of 40 mg/m³. In addition, live birth and viability indices of pups in all test groups were not influenced. Concerning clinical pathology no treatment-related, adverse effects were observed up to a dose level of 40 mg/m3. With regard to pathology, treatment-related microscopic changes were observed in larynx (level 1) and consisted of increased squamous metaplasia of the respiratory epithelium and chronic (active) inflammation at level 1 of the larynx only to a marginal or slight degree. This was observed in both sexes. Histopathological examination of the mid- and low-dose groups of the larynx at this level 1 revealed that these treatment-related findings (squamous metaplasia and chronic [active] inflammation) were also observed in the mid-dose group (16 mg/m³), however, to a lesser severity degree compared to the high-dose groups (40 mg/m³). Other macroscopic and/or microscopic changes observed were either non-dose related and/or considered to be normal background changes. No treatment-related changes were observed in both sexes at a concentration of 4 mg/m³.

Thus, the no observed adverse effect concentration (NOAEC) for general systemic toxicity as well as reproductive performance, fertility and developmental toxicity was 40 mg/m³. The NOAEC for local effects was 4 mg/m³.

Justification for classification or non-classification

Classification for repeated dose toxicity 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.