Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Explanation for the modification of the dose descriptor starting point:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Explanation for the modification of the dose descriptor starting point:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Explanation for the modification of the dose descriptor starting point:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Workers - Hazard for the eyes

Additional information - workers

An update of the tonnage band to 10-100 tonnes is planned for x.y-dialkyldihydro-oxazolo-oxazole (Sa 190) following a tiered approach for generating and providing the required toxicological data. We have identified genotoxicity as a knock-out criterion for further using Sa 190 in our products. Therefore, as a first step we have conducted in vitro genotoxicity tests as required according to Annex VIII, Section 8.4 (in vitro chromosome aberration (OECD TG 473) and in vitro gene mutation test with mammalian cells (HPRT, OECD TG 476)). While the gene mutation test yielded a negative result, the chromosome aberration test was positive (see section 7.6.1). Taking into account the available negative results of gene mutation tests (1. with bacteria (AMES) and 2. with mammalian cells), from a scientific point of view there is no concern regarding gene mutation. However, since the in vitro chromosome aberration test was positive, the substances might have a clastogenic potential. According to the REACH regulation, "appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII". A micronucleus assay according to OECD TG 474 is such an appropriate study. In section 7.6.2 of this dossier we therefore propose to conduct an in vivo micronucleus assay. In addition to the clarification required by the the REACh regulation, we will discontinue using Sa 190 in our products if a clastogenic potential would be confirmed, and thus we would also not need to update the tonnage band in this case. Therefore, we decided not to continue the preparations for the planned tonnage band update until it is clarified whether Sa 190 has a clastogenic potential. Missing toxicological data will be generated and respective DNEL's derived as soon as possible after a negative outcome of the proposed in vivo micronucleus test.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Explanation for the modification of the dose descriptor starting point:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Explanation for the modification of the dose descriptor starting point:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other:
Dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Explanation for the modification of the dose descriptor starting point:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Explanation for the modification of the dose descriptor starting point:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

General Population - Hazard for the eyes

Additional information - General Population

An update of the tonnage band to 10-100 tonnes is planned for x.y-dialkyldihydro-oxazolo-oxazole (Sa 190) following a tiered approach for generating and providing the required toxicological data. We have identified genotoxicity as a knock-out criterion for further using Sa 190 in our products. Therefore, as a first step we have conducted in vitro genotoxicity tests as required according to Annex VIII, Section 8.4 (in vitro chromosome aberration (OECD TG 473) and in vitro gene mutation test with mammalian cells (HPRT, OECD TG 476)). While the gene mutation test yielded a negative result, the chromosome aberration test was positive (see section 7.6.1). Taking into account the available negative results of gene mutation tests (1. with bacteria (AMES) and 2. with mammalian cells), from a scientific point of view there is no concern regarding gene mutation. However, since the in vitro chromosome aberration test was positive, the substances might have a clastogenic potential. According to the REACH regulation, "appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII". A micronucleus assay according to OECD TG 474 is such an appropriate study. In section 7.6.2 of this dossier we therefore propose to conduct an in vivo micronucleus assay. In addition to the clarification required by the the REACh regulation, we will discontinue using Sa 190 in our products if a clastogenic potential would be confirmed, and thus we would also not need to update the tonnage band in this case. Therefore, we decided not to continue the preparations for the planned tonnage band update until it is clarified whether Sa 190 has a clastogenic potential. Missing toxicological data will be generated and respective DNEL's derived as soon as possible after a negative outcome of the proposed in vivo micronucleus test.