EU-SICHERHEITSDATENBLATT Dieselkraftstoff ... - Schmierstoffe
EU-SICHERHEITSDATENBLATT Dieselkraftstoff ... - Schmierstoffe EU-SICHERHEITSDATENBLATT Dieselkraftstoff ... - Schmierstoffe
Vacuum Gas Oils, Hydrocracked Gas Oils, and Distillate Fuels Table 2: Toxicological Endpoint Category Values for Vacuum Gas Oils, Hydrocracked Gas Oils & Distillate Fuels. Endpoint 3 8.1 Skin irritation or skin Corrosion 8.1.1 In vivo skin irritation 8.2 Eye irritation 8.2.1 In vivo eye irritation 8.3 Skin sensitisation 8.4 Mutagenicity 8.4.1 In vitro gene mutation study In Bacteria 8.4.2 In vitro cytogenicity study in mammalian cells 8.4.3 In vitro gene mutation study in mammalian cells 8.4.4 In vivo cytogenicity 8.4.5 In vivo gene Relevance to Category Derived Category Value Comment Yes Irritant Based on key study test data Yes Mild irritant Based on key study test data Yes Not sensitising Based on key study test data Yes Positive Based on key study test data Yes Yes Yes No data Positive & Ambiguous No data Based on read across supporting studies Yes Negative Based on key study test data mutation 8.5 Acute toxicity 8.5.1 By oral route Yes LD 50 : > 7600 mg/kg Based on key study test data 8.5.2 By inhalation Yes LC 50 : 4.1 mg/l Based on key study test data 8.5.3 By dermal route 8.6 Repeated dose toxicity 8.6.1 Short-term repeated dose toxicity study (28 days) 8.6.2 Sub-chronic toxicity study (90- day) Yes LD 50 : > 4300 mg/kg Based on key study test data yes yes Dermal rat NOAEL 0.5 ml/kg Inhalation rat NOAEC >1710 mg/m 3 Based on key study test data Based on test data from key studies 8.7 Reproductive toxicity 8.7.1 Screening for reproductive/ developmental toxicity (OECD 421 or 422) 8.7.2 Pre-natal developmental Toxicity Study No Yes Dermal rat, NOAEL 30 mg/kg/day No data Negative Inhalation NOAEC >401 ppm Based on key studies test data Dermal: NOAEL developmental 125 mg/kg/day, NOAEL maternal toxicity 3 In accordance with Annexes VII to X of REACH 2010-07-30 CSR Appendix 1
Vacuum Gas Oils, Hydrocracked Gas Oils, and Distillate Fuels Endpoint 3 8.7.3 Onegeneration reproductive toxicity study 8.8 Toxicokinetics 8.8.1 Assessment of the Toxicokinetic behaviour of the substance 8.9 Carcinogenicity 8.9.1 Carcinogenicity study Relevance to Category Yes Derived Category Value 125 mg/kg No data from reproductive studies Comment No No data Substances in this category are UVCBs. It is not possible to apply standard methodology for assessing absorption, distribution and metabolism. Data on constituents can be used as the basis for understanding the toxicokinetics are included in the dossier Yes Carcinogenic Key study test data indicate low carcinogenic potential in line with the harmonised classification. ‣ Eco-toxicological Information (Section 9 of REACH Annexes VII-X) Many of the standard test methods for environmental endpoints are not suitable for assessing the hazards of complex UVCB petroleum substances. Hence it has been necessary to develop alternative methodologies e.g. use of water accommodated fractions, which are more suitable for predicting the hazard properties of complex petroleum substances, for classification purposes. A number of environmental endpoints are not relevant to the overall UVCB petroleum substance. The type, concentration, and physical-chemical properties of individual chemical constituents present will influence the environmental distribution and fate of category members. Hence, an alternative strategy, based on the ‘Hydrocarbon Block Method’, has been developed for assessing the environmental risk related to the constituents present in UVCB petroleum substances (European Chemicals Bureau, Technical Guidance Document on Risk Assessment, Part II, 2003). For the purposes of ecological hazard endpoint evaluation, data on individual CAS Registry Numbers from the category have been used. Unless specified, in all cases a ‘worst case’ approach has been applied to identify a category value, with some being assigned on the basis of data available for constituents. Table 3 summarises the data available Table 3: Eco-toxicological endpoint category values for Vacuum or Hydrocracked Gas Oils & Distillate Fuels. Endpoint 9.1 Aquatic toxicity 9.1.1 Short-term toxicity testing on invertebrates (preferred species Daphnia) Relevance to Category Yes Derived Category Value EL50 68 mg/l (48 h) (Daphnia magna) Comment Based on key study. 9.1.2 Growth inhibition study aquatic plants (algae preferred) Yes IL50 22 mg/l (72 h) (Raphidocelis subcapitata) Based on key study. 9.1.3 Short-term toxicity Yes LL50 Based on key study. 2010-07-30 CSR Appendix 1
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Vacuum Gas Oils, Hydrocracked Gas Oils, and Distillate Fuels<br />
Endpoint 3<br />
8.7.3 Onegeneration<br />
reproductive toxicity<br />
study<br />
8.8 Toxicokinetics<br />
8.8.1 Assessment of<br />
the Toxicokinetic<br />
behaviour of the<br />
substance<br />
8.9 Carcinogenicity<br />
8.9.1 Carcinogenicity<br />
study<br />
Relevance<br />
to<br />
Category<br />
Yes<br />
Derived Category<br />
Value<br />
125 mg/kg<br />
No data from<br />
reproductive<br />
studies<br />
Comment<br />
No No data Substances in this category are UVCBs.<br />
It is not possible to apply standard<br />
methodology for assessing absorption,<br />
distribution and metabolism. Data on<br />
constituents can be used as the basis<br />
for understanding the toxicokinetics are<br />
included in the dossier<br />
Yes Carcinogenic Key study test data indicate low<br />
carcinogenic potential in line with the<br />
harmonised classification.<br />
‣ Eco-toxicological Information (Section 9 of REACH Annexes VII-X)<br />
Many of the standard test methods for environmental endpoints are not suitable for assessing the<br />
hazards of complex UVCB petroleum substances. Hence it has been necessary to develop alternative<br />
methodologies e.g. use of water accommodated fractions, which are more suitable for predicting the<br />
hazard properties of complex petroleum substances, for classification purposes.<br />
A number of environmental endpoints are not relevant to the overall UVCB petroleum substance. The<br />
type, concentration, and physical-chemical properties of individual chemical constituents present will<br />
influence the environmental distribution and fate of category members. Hence, an alternative strategy,<br />
based on the ‘Hydrocarbon Block Method’, has been developed for assessing the environmental risk<br />
related to the constituents present in UVCB petroleum substances (European Chemicals Bureau,<br />
Technical Guidance Document on Risk Assessment, Part II, 2003).<br />
For the purposes of ecological hazard endpoint evaluation, data on individual CAS Registry Numbers<br />
from the category have been used. Unless specified, in all cases a ‘worst case’ approach has been<br />
applied to identify a category value, with some being assigned on the basis of data available for<br />
constituents. Table 3 summarises the data available<br />
Table 3: Eco-toxicological endpoint category values for Vacuum or Hydrocracked Gas Oils &<br />
Distillate Fuels.<br />
Endpoint<br />
9.1 Aquatic toxicity<br />
9.1.1 Short-term toxicity<br />
testing on invertebrates<br />
(preferred species Daphnia)<br />
Relevance to<br />
Category<br />
Yes<br />
Derived Category<br />
Value<br />
EL50<br />
68 mg/l<br />
(48 h)<br />
(Daphnia magna)<br />
Comment<br />
Based on key study.<br />
9.1.2 Growth inhibition study<br />
aquatic plants (algae<br />
preferred)<br />
Yes<br />
IL50<br />
22 mg/l<br />
(72 h)<br />
(Raphidocelis<br />
subcapitata)<br />
Based on key study.<br />
9.1.3 Short-term toxicity Yes LL50 Based on key study.<br />
2010-07-30 CSR Appendix 1