Fusanus spicatus, ext.

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

see Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1) B.1 bis

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

July 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

AnimaIs: The experiment was performed in Wistar rats (ordered as SPF-status) of the stock Mol:WIST from M & B, Ejby, DK-4623 Lille Skensved, Denmark. On the day of treatment the rats in the main study were 6 to 7 weeks old and weighed from 144 to 154 g. An acclimatisation period of at least 5 days was allowed.
Housing: The study took place in animal room No 13 provided with filtered air at a temperature of 21 °C ±3 °C and relative humidity of 55% ±15%. The room has been designed to give 10 air changes per hour and was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 0600 h to 1800 h.
The rats were kept in transparent polycarbonate cages (macrolone type III, floor area 810 cm²) with two or three in each cage, males and females separated. The cages were cleaned and the bedding changed at least twice a week. Before the animals arrived, the animal room was cleaned and disinfected with Glu-Cid®. During the study the animal room was cleaned regularly and rinsed with water.
Bedding: Bedding was softwood sawdust ”LIGNOCEL 3-4” from Hahn & Co, D-24796 Bredenbek-Kronsburg. Regular analyses for relevant possible contaminants are performed.
Diet: A pelleted complete rodent diet ”Altromin 1314" from Chr. Petersen A/S, DK-4100 Ringsted was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
Drinking water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly.

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Remarks:

sesame oil

Details on oral exposure:

Treatment procedure: The test article suspended in sesame oil was administered orally by gavage to rats that had been fasted overnight. After treatment the feed was withheld for a further 3 hours.
The study was initiated with a sighting study: One female rat was given 2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight. Signs of evident toxicity were observed in this rat.
On the basis of the results of the sighting study the main study was carried out with one group consisting of five male and five female rats given a dose of 2000 mg Aus. sandalwood oil. S. spicatum oil/kg body weight. The dose volume administered was 10 ml/kg body weight both in the sighting and the main study.

Doses:

2000 mg/kg b.wt.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Clinical signs: Each rat was observed at least 1, 3 and 6 hours after administration and thereafter daily for a period of 14 consecutive days.
Body weights (b.wt.) were recorded on days 1, 2, 3, 4, 8 and 15.
Necropsy: The rat in the pilot study and all rats in the main study were killed on day 15 by an intraperitoneal injection of 5% Mebumal®. All animals were subjected to a gross necropsy examination.

Statistics:

none

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died at the selected dose level nor did they show signs of evident toxicity during the study period.

Clinical signs:

other: Piloerection was seen in one animal 1 hour after treatment, in one animal 3 hours after treatment, in two animals 6 hours after treatment and in one animal on day 2 after termination of treatment. Tremor and subdued behaviour was seen in one animal 6 hour

Gross pathology:

The post-mortem inspection revealed hydronephrosis of the right kidney of animal No 23. No abnormalities were seen in the other animals. Hydronephrosis is an incidental finding in this strain of rats and is considered not to be related to the test article.

Table: body weight development during main study

Rat No	Dose (mg/kg bw)	Sex	Day 1	Day 2	Day 3	Day 4	Day 8	Day 15
21	2000	Male	154	174	185	191	223	277
22	2000	Male	153	165	176	182	206	258
23	2000	Male	154	168	175	183	208	261
24	2000	Male	150	151	I64	171	199	256
25	2000	Male	147	157	163	169	191	237
26	2000	Female	146	158	158	167	185	202
27	2000	Female	147	157	160	167	182	198
28	2000	Female	144	155	164	168	182	203
29	2000	Female	144	160	157	160	169	184
30	2000	Female	148	150	158	167	181	199

 

Table: daily observations during main study

	Rat No.(sex)
	21(m)	22(m)	23(m)	24(m)	25(m)	26(f)	27(f)	28(f)	29(f)	30(f)
Day 1, 1h	N	N	N	N	N	N	N	P	N	N
Day 1, 3h	N	N	N	N	N	N	N	N	P	N
Day 1, 6h	N	N	N	N	ST	P	N	N	P	N
Day 2	N	N	N	P	N	N	N	N	N	N
Day 3	N	N	N	N	N	N	N	N	N	N
Day 4	N	N	N	N	N	N	N	N	N	N
Day 5	N	N	N	N	N	N	N	N	N	N
Day 6	N	N	N	N	N	N	N	N	N	N
Day 7	N	N	N	N	N	N	N	N	N	N
Day 8	N	N	N	N	N	N	N	N	N	N
Day 9	N	N	N	N	N	N	N	N	N	N
Day 10	N	N	N	N	N	N	N	N	N	N
Day 11	N	N	N	N	N	N	N	N	N	N
Day 12	N	N	N	N	N	N	N	N	N	N
Day 13	N	N	N	N	N	N	N	N	N	N
Day 14	N	N	N	N	N	N	N	N	N	N
Day 15	N	N	N	N	N	N	N	N	N	N

 

Key to daily observations: A = Ataxia, B = Notes, C = Unconscious, D = Diarrhoea, E = Moribund, F = Nasal discharge, G = Lacrimation, H = Hyperventilation, K = Salivation, L = Flaccid, M = Thin, N = Normal, O = Pinched abdomen, P = Piloerection, R = Laboured respiration, S = Subdued, T = Tremor, U = Distended abdomen

Interpretation of results:

GHS criteria not met

Conclusions:

The LD0 (oral, rat) was found being >2000 mg/kg bw.

Executive summary:

The acute oral toxicity of Australian sandalwood oil, S. spicatum oil in rats was determined according to the method recommended in the OECD Guideline No 420, "Acute Oral Toxicity - Fixed Dose Method”, July 1992 and the EEC Directive published in: “Official Journal of the European communities” No: L 383A, volume 35, 29.12.1992, part B1 “Acute Toxicity (Oral) - Fixed Dose Method”.

The study was initiated with a sighting study, in which one female rat was given 2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight. Signs of evident toxicity were observed in this rat.

On the basis of the results of the sighting study the main study was carried out with one group consisting of five male and five female rats given a dose of 2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight.

All animals in the main study survived the treatment and showed no signs of evident toxicity.

The rats had a normal body weight gain during the study period.

Under the experimental conditions described in this report, it was found that the dose level tested (2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight), highest required dose level, did not produce mortality. The minimal lethal dose was above 2000 mg Australian sandalwood oil, S. spicatum oil/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on an acute oral toxicity study according to OECD 420 a dose of 2000 mg/kg bw caused no mortality to 10 test animals. Thus, the substance is not subject to classification according to GHS or CLP (Regulation EC No 1272/2008) for acute toxicity or for Specific Target Organ Toxicity, single exposure (STOT SE), as no substance specific toxic effects were observed.