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REACH

Santalene oil: fermentation products of glucose with santalene synthase modified Rhodobacter sphaeroides, distilled

EC number: 950-969-7 | CAS number: -

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

Oral: OECD TG 423, GLP-compliant, female Wistar rats, Limit test, LD50 > 2000 mg/kg bw (BASF 2020; 10A0058/20X008)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed
Dose descriptor:: LD50
Value:: > 2 000 mg/kg bw
Quality of whole database:: according to OECD TG 423, GLP-compliant, Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:: no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:: no study available

Additional information

In the key study for acute oral toxicity (according to OECD TG 423 ; GLP-compliant), a single dose of 2000 mg/kg bw of undiluted Santalene oil was administered by gavage to two test groups of three female Wistar rats each (BASF 2020; 10A0058/20X008). No mortality or clinical signs occurred at the end of the observation period of 14 days. All animals gained weight in a normal range throughout the study period and there were no macroscopic pathological findings in any animal sacrificed at the end of the observation period. Under the conditions of this study, the median lethal dose (LD50) of Santalene oil after oral administration was assessed to be greater than 2000 mg/kg bw in rats.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred in an oral toxicity study at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.

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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