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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics, other
Type of information:
other: expert statement
Adequacy of study:
key study
Executive summary:

Absorption

The rather high molecular weight (650.6 - 1299), low water solubility < 0.01 mg/L at 20°C) and high lipophilicity (Log10Pow = 5.5 at 25°C) of ADK STAB FP-900L would be expected to limit its absorption across the skin after topical administration and to limit its absorption after oral administration [ECHA 2017, Chapter R.7c: Endpoint specific guidance]. Consequently the above physicochemical properties of ADK STAB FP-900L are considered to limit its systemic availability both, after topical and after oral administration. This is consistent with the absence of relevant signs of irritation in an acute dermal toxicity study in the rat, skin and eye irritation studies in the rabbit and a Local Lymph Node Assay (LLNA) in mice and with the absence of any sensitization response in the latter study. In addition, in a repeat dose oral toxicity study (OECD 407), in which rats received doses of up to 1000 mg/kg/day on 28 consecutive days, findings indicative of absorption or systemic exposure were not evident after 4 treatment weeks and also not after a subsequent 2-week treatment free recovery period.

No data is available on absorption after inhalation. However, inhalation of any vapour from ADK STAB FP-900L is an unlikely route of human exposure, because the substance has a very low vapour pressure (5.3 x 10E-5 Pa at 25°C) and decomposes without boiling at high temperatures (≥ ca. 260°C). Exposure of humans to an inhalable aerosol of ADK STAB FP-900L is also unlikely because the substance is a viscous liquid.

From the absence of any toxicity in all available toxicity studies and the absence of any relevant adverse effects in in-vitro genotoxicity tests or on algae, daphnia, fish or bacteria in ecotoxicology studies, and from the fact of not being readily biodegradable and not predicted as oxidising, it is concluded that ADK STAB FP-900L may behave quasi-inert in biological systems.

 

Distribution, metabolism, and excretion

All available study results gave no indication regarding the metabolic pathway, distribution or excretion of ADK STAB FP-900L.

 

Bioaccumulation

The substance is not expected to have a bioaccumulation potential. No effects were observed in the sub-chronic oral toxicity study after 28 days of repeated dosing at a level of 1000 mg/kg body weight/day. In a study for determination of bioaccumulation in fish no accumulation potential was evident (BCF < 100).

Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Absorption

The rather high molecular weight (650.6 - 1299), low water solubility < 0.01 mg/L at 20°C) and high lipophilicity (Log10Pow = 5.5 at 25°C) of ADK STAB FP-900L would be expected to limit its absorption across the skin after topical administration and to limit its absorption after oral administration [ECHA 2017, Chapter R.7c: Endpoint specific guidance]. Consequently the above physicochemical properties of ADK STAB FP-900L are considered to limit its systemic availability both, after topical and after oral administration. This is consistent with the absence of relevant signs of irritation in an acute dermal toxicity study in the rat, skin and eye irritation studies in the rabbit and a Local Lymph Node Assay (LLNA) in mice and with the absence of any sensitization response in the latter study. In addition, in a repeat dose oral toxicity study (OECD 407), in which rats received doses of up to 1000 mg/kg/day on 28 consecutive days, findings indicative of absorption or systemic exposure were not evident after 4 treatment weeks and also not after a subsequent 2-week treatment free recovery period.

No data is available on absorption after inhalation. However, inhalation of any vapour from ADK STAB FP-900L is an unlikely route of human exposure, because the substance has a very low vapour pressure (5.3 x 10E-5 Pa at 25°C) and decomposes without boiling at high temperatures (≥ ca. 260°C). Exposure of humans to an inhalable aerosol of ADK STAB FP-900L is also unlikely because the substance is a viscous liquid.

From the absence of any toxicity in all available toxicity studies and the absence of any relevant adverse effects in in-vitro genotoxicity tests or on algae, daphnia, fish or bacteria in ecotoxicology studies, and from the fact of not being readily biodegradable and not predicted as oxidising, it is concluded that ADK STAB FP-900L may behave quasi-inert in biological systems.

 

Distribution, metabolism, and excretion

All available study results gave no indication regarding the metabolic pathway, distribution or excretion of ADK STAB FP-900L.

 

Bioaccumulation

The substance is not expected to have a bioaccumulation potential. No effects were observed in the sub-chronic oral toxicity study after 28 days of repeated dosing at a level of 1000 mg/kg body weight/day. In a study for determination of bioaccumulation in fish no accumulation potential was evident (BCF < 100).