Registration Dossier
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EC number: 298-078-6 | CAS number: 93777-46-9
Endpoint summary
Administrative data
Description of key information
Oral (OECD 407): NOAEL ≥ 1000 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties> (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity
Justification for read-across
There are no measured/experimental data for repeated dose toxicity available on Decyl 2-Ethylhexanoate (CAS 93777-46-9). To fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.6, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.
For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).
As no measured/experimental data are available on repeated dose toxicity, read-across to reliable data on the analogue substance Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) was conducted.
CAS 135800-37-2
Repeated dose toxicity of Fatty acids, C8-16, 2-ethylhexyl esters was tested in a GLP-compliant toxicity study performed according to OECD 407 (Fitzgerald, 1991). Groups of 5 male and female Sprague-Dawley rats received daily oral gavage doses of the test substance in corn oil at dose levels of 100, 300 and 1000 mg/kg bw/day. Concurrent negative control animals received the vehicle alone. No mortality and signs of clinical toxicity were observed during the study period. No effects on body weight evolution, food consumption, and neurobehavior were observed. Hematology and clinical parameters were not affected by treatment. The relative kidney and liver weights were significantly different in male animals treated with 100 mg/kg bw/day compared with control animals. Due to missing dose-response, these changes are not considered as treatment related. Moreover, histopathology did not reveal treatment-related abnormalities. Based on the lack of adverse effects, a NOAEL ≥ 1000 mg/kg bw/day was derived in the conducted study.
Conclusion on repeated dose toxicity
The available data show that the analogue substance Fatty acids, C8-16, 2-ethylhexyl esters does not possess intrinsic hazardous properties in regard to repeated dose toxicity. Therefore, based on common functional groups and structural similarities, the test substance Decyl 2-Ethylhexanoate (CAS 93777-46-9) is considered to be non-hazardous after short-term exposure.
Justification for classification or non-classification
Based on the analogue read-across approach, the available data on repeated dose toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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