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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Toxicokinetic date are not available. But taking into account the physico-chemical properties and the toxicological test results, qualitative estimates for these aspects were deduced for DOBA. Based on these date DOBA is considered 
- to posses only very low toxicity, and/or
- not to be absorbed in relevant amounts, and
- not to have a significant bioaccumulation potential

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The toxicokinetic profile of a substance comprises its absorption into the body, its distribution in the body, its metabolism in the body and its excretion from the body. Taking into account the physico-chemical properties and the toxicological test results, qualitative estimates for these aspects may be deduced for DOBA.

Absorption: a prerequisite for a relevant absorption is that the substance can be dissolved in either aqueous (e.g., gastrointestinal fluid, blood plasma, sweat) or lipophilic (e.g., lipoproteins, lipid membranes, triglycerides) media or in both. DOBA can be considered to be soluble to a certain extent in water (solubility: 1.1 mg/L) and n-octanol (logPow: 4). Considering additionally the low molecular mass (276 g/mol), it is not unlikely that DOBA may become systemically bioavailable after oral, dermal or inhalation exposure.

The results of acute oral toxicity, acute dermal toxicity, repeated dose toxicity, and the reproduction / developmental toxicity screening studies also give valuable indications with regard to absorption and/or toxicity of the test substance.

Based on the acute oral, acute dermal and the repeated dose toxicity, and the reproduction / developmental toxicity screening studies, which did not reveal any systemic effects, it can be assumed that the test substance is either not toxic or did not enter the body, in amounts sufficient to cause adverse effects.

DOBA does not have particular skin or eye irritating or skin sensitizing properties that would imply a dermal absorptive potential. In addition, in the acute dermal toxicity study no signs of absorption, or systemic toxicity were observed.

Based on the low vapor pressure (0.00095 Pa at 20°C), the particle size distribution (D10 12.7 µm; D50 51.4 µm; D90 104.0 µm), and the intended use exposure to vapor or aerosolized particles in respirable form is unlikely. Therefore a dose delivered via inhalation can be considered to be negligible.

Distribution: the repeated dose toxicity, and the reproduction / developmental toxicity screening study did not indicate any relevant histopathological changes in any of the investigated organs. This may indicate that either the substance does not affect special organs as targets, i.e., is non-toxic, or is not distributed within the body in amounts sufficient to cause adverse effects. There were also no other signs of deposition of the substance in any organ including excretory organs, like the kidney, indicating that even exposure to high doses does not lead to bioaccumulation in special compartments of the body.

Metabolism: The results of the mutagenicity tests provide indications for qualitative consideration of the metabolic fate of DOBA. In the AMES test and the chromosome aberration test metabolic activation caused a reduction of the existing cytotoxicity demonstrating the detoxifying nature of the metabolic activation system.

In addition the lack of any morphological and histopathological changes of organs involved in xenobiotic metabolism, such as the liver, in the repeated dose toxicity study indicates that no toxic metabolites will be formed in vivo as well.

Excretion: The absence of any adverse effects in acute and repeated dose toxicity tests give rise to the conclusion that the substance is not absorbed in relevant amounts and/or its toxic potency is very low. In the case of missing absorption, excretion is not an issue. In the case of low toxicity this means that the substance itself is non-toxic and might be excreted unchanged. Or alternatively the substance is metabolized into non-toxic metabolites which were excreted or incorporated into natural metabolic pathways. Regardless of which kind of elimination actually occurs none of these options is correlated with adverse systemic effects as shown in repeated dose studies.