Lavender, Lavandula angustifolia, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February - April 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: French Norm NF T 03-021 détermination de la toxicité aigüe chez le Rat, administration unique orale"

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Lavender, Lavandula angustifolia, ext.

EC Number:

289-995-2

EC Name:

Lavender, Lavandula angustifolia, ext.

Cas Number:

90063-37-9

Molecular formula:

not relevant for a UVCB substance

IUPAC Name:

Essential oil of Lavandula angustifolia Mill. (Lamiaceae) obtained from flowering tops by steam distillation

Test material form:

liquid

Details on test material:

Lavande vraie, huile essentielle de Lavandula officinalis Chaix received on 20 January 1989

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO (Domaine des Oncins, 69210 L'Arbresle France)
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Weight at study initiation: 150g
- Housing: group of 5 animals, in Makrolon polycarbonate Bayer Techniplast cage
- Diet ad libitum, exept 18 hours before administration of the test item
- Water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 15 volum per hour
- Photoperiod (hrs dark / hrs light): 12H dark/ 12 H light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

3, 4,5,6, and 7 ml/kg body weight

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes

Remarks:

dosed with volume of 7ml/kg of filtered water

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation before administration of the test item, and then twice a day exept on saturday and sunday (once a day). Weighing at day : D-1, D1, D2, D3, D8 and D15.
- Necropsy of animails dying during the study, and macroscopic examination
- Necropsy of survivors performed: yes: macropsy of abdominals and thoracic organs
- Other examinations performed: clinical signs, body weight, food and water consumption

Statistics:

Statistical interpretation of the weight evolution: study of the homogeneity of the body weights tested before the treatment by comparison of the variances of the animals group (test of Bartlett), then comparition of the means of the groups or the rows (ANVA 1 if the variances are homogeneous, test of Kruskal-Wallis if they are heterogeneous).
The study of the effect of the treatment is carried out by ANVA1 per day of measurement after tests of variances. In the case of a sinificative difference, the direction of the difference is sought by the Dunnett t test


The results are averaged, the average is accompanied by the estimated standard deviation of the mean.The DL 50 is evaluated by the Miller & Tanner method.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5.4 - < 7 mL/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 4.1 - < 5.9 mL/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male

Dose descriptor:

LD0

Effect level:

5 mL/kg bw

Based on:

test mat.

Effect levels 4

Sex:

female

Dose descriptor:

LD0

Effect level:

3 mL/kg bw

Based on:

test mat.

Effect levels 5

Sex:

male

Dose descriptor:

LD100

Effect level:

> 7 mL/kg bw

Based on:

test mat.

Effect levels 6

Sex:

female

Dose descriptor:

LD100

Effect level:

> 6 mg/kg bw

Based on:

test mat.

Mortality:

Late mortality occurs approximately 20 hours after oral treatment and extends up to 32 hours. No animal died in group treated at 3 ml/kg.
No males died in groups treated at 4 and 5 ml/kg.
One female died in group treated at 4 ml/kg and one in the group treated at 5 ml/kg.
In group treated at 6 ml/kg 2 males died and all the females (see table 1 in any other information on results)

Clinical signs:

other: The toxic symptomatology appears in 1 hour in male and female: abatement, abdominal contractions and / or piloerection. These symptoms disappear at the end of the day in the 3 ml / kg (male and female) treated groupand in animals treated at 4 and 5 ml / k

Other findings:

Other fidings In both sexes, food consumption is greatly reduced within 24 hours of single treatment, and for all treated groups. Dietary intakes were comparable to those of controls after days in the 4 and 5 mL / kg treated animals and after 3 days in the 6 and 7 mL / kg treated groups. Subsequently drinking is similar for all animals.

Any other information on results incl. tables

Table 1: mortality :

Dose (ml/kg)	Male dead	Female dead
0	0/5	0/5
3	0/5	0/5
4	0/5	1/5 (in 24 hours)
5	0/5	1/5 (in 24 hours)
6	2/5 (in 24 hours)	5/5 (in 24 hours)
7	3/5 (in 24 hours) 4/5 (in 32 hours)	3/5 (in 24 hours) 5/5 (in 32 hours)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.

Executive summary:

In an acute oral toxicity study 5 male rats and 5 female rats were given single oral doses of Lavander oil at 3 or 4 or 5 or 6 or 7 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.

There is no mortality for males dosed up to 5 mL/ kg bw. At 6 mL/ kg bw 2 males died, and 4 at 7 mL/kg bw.

At 4 and 5 mL/kg bw one female died, and at 6 and 7 mL/kg bw all female died.

The Oral LD50 was calculated at 6.2 +/- 0.8 mL/kg for male and at 5.0 +/-0.9 mL/kg bw for female.

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.