Shale oils, heavy

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Study period:

to be confirmed

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented

the study does not need to be conducted because the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented

no further testing on fertility is necessary because the substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment and classification and labelling

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to column 2 of REACH Annex IX, section 8.7, a reproductive toxicity study does not need to be conducted if the substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment. Since the substance is reasonably known to be toxic for reproduction category 1B, and specifically may damage fertility (H360F), and bearing in mind the exposure assessment indicates no risk (due to the operational controls and risk management measures that are implemented), further testing for reproductive toxicity is neither considered necessary nor considered to be an expedient or responsible use of animals.
Additionally, column 2 of REACH Annex IX further stipulates that additional reproductive toxicity studies do not need to be conducted if the substance is known to be a genotoxic carcinogen and/or a known germ cell mutagen and appropriate risk management measures are implemented. Since the substance is reasonably known to be carcinogenic and mutagenic (category 1B), and since appropriate risk management measures are implemented, this further substantiates the lack of need for additional testing.
Please refer to the attached document '1904651.UK0 - 7899 Consideration of the long term toxicity of Distillates (shale oil)' for further information.

Materials and methods

Principles of method if other than guideline:

Shale oil, a UVCB (Unknown or Variable composition, Complex reaction products or Biological materials) substance mainly consisting of hydrocarbons, is produced by VKG Oil and marketed in three shale oil fractions: a Light, Middle and Heavy fraction.
Given the supply levels of these fractions, the performance of a repeated-dose sub-chronic oral (90-day) and an extended one-generation reproductive toxicity study (EOGRTS) for each shale oil fraction, is triggered. Nevertheless, VKG Oil proposed to test only the Heavy shale oil fraction and apply the endpoints to all three shale oil fractions.
ECHA studied this proposal and issued a Draft decision on the testing proposal for each fraction, not accepting that the Heavy fraction results would represent a worst-case result for the Light and Middle fractions.
From the responses, it is evident that although ECHA’s concerns are at first glance reasonable, scientific evidence gives confidence in the proposed read-across.
More specifically, the Heavy fraction can be considered to offer worst-case results to the Light and Middle fraction when tested for repeated-dose toxicity (90-day oral study). Furthermore, the Heavy fraction can be considered as worst case when tested for reproductive toxicity (EOGRTS).

In order to allay the concerns regarding human health safety, VKG Oil makes a new proposal, according to which no further animal testing is performed, and VKG Oil adopts a conservative classification and labelling regarding human health effects:

Risk assessment is performed based on the most toxicologically relevant component, benzo(a)pyrene. Classification and DNELs can be derived based on calculation from the OEL recognised at European level. Even at 12% , the presence of PAHs are still the only component that need to be taken into consideration in the derivation of DNELs, because comparison of existing reference doses and exposure limits show that for PAHs are 10,000 lower than next lowest reference dose i.e. extrapolating the OEL for each oil fraction from the PAH content still results in the lowers OEL, than if were done based on the content of the remaining materials. See the attached document: "Shale oil: comments on ECHA’s Draft decision".

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified