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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesanstalt für Umwelt Baden - Württemberg, 12.11.2019

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

950-969-7

Molecular formula:

not applicable

IUPAC Name:

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

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Rat / Wistar / Crl:WI (Han) SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 10-11 weeks
- Weight at study initiation: Animals of comparable weight, mean weight of approx. 184 g (SD 1.53)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration.
- Housing: Single housing, Makrolon cage, type III;
- Enrichment: Wooden gnawing blocks (Type NGM E-022);
- Diet: LASQCdiet® Rod16, HiHyg, LASvendi (Altromin, 32791 Lage, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
- Microbiological status when known: SPF

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C +- 3°C
- Humidity: 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: april 20, 2020- may 13, 2020

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.21 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6/f/dose

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 14 days
- Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
- Clinical signs: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes

No histological examinations were performed.

Statistics:

Not specified

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both test groups.

Clinical signs:

other: No clinical signs were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A LD50 > 2000 mg/kg bw was determined in an oral gavage study for female rats.

Executive summary:

An acute oral toxicity study was conducted according to OECD TG 423 (GLP-compliant) with female Wistar rats. A single dose of 2000 mg/kg bw of the undiluted test item was administered by gavage to two test groups of three rats each (6 females). No mortality or clinical signs occured 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 of the test item after oral administration was assessed to be greater than 2000 mg/kg bw in rats.