Lavender, Lavandula angustifolia, ext.

Endpoint summary

Description of key information

In an acute oral toxicity study on rats, the Oral LD50 was calculated at 6.2 +/- 0.8 mL/kg for males and at 5.0 +/-0.9 mL/kg bw for females. (Rel. K2)

In an acute dermal toxicity study, the dermal LD50 of Lavender oil was higher than 5000 mg/kg bw in rats (Rel. K2).

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:

February - April 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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

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

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

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.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5.4 - < 7 mL/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 4.1 - < 5.9 mL/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD0

Effect level:

5 mL/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD0

Effect level:

3 mL/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD100

Effect level:

> 7 mL/kg bw

Based on:

test mat.

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.

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)

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Principles of method if other than guideline:

Standard acute method (limit test): 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

None

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

None

Duration of exposure:

After single application of the test subsance, all animals were observed for 14 days.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 rabbits

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: Mortality, clinical signs and dermal reactions.
- Necropsy of survivors performed: No

Statistics:

None

Preliminary study:

Not applicable

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: indication of slight to moderate irritation

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs of toxicity occurred during the study.

Gross pathology:

Not applicable

Other findings:

- Dermal reactions: Slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the dermal LD50 of the test substance is >5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Executive summary:

In an acute dermal toxicity study (limit test), 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.

No deaths and no clinical signs of toxicity occurred during the observation period. Dermal reactions noted were slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.

Under the test conditions, the dermal LD50 of the test substance is >5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Additional information

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.

In an acute dermal toxicity study (limit test), 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.

No deaths and no clinical signs of toxicity occurred during the observation period. Dermal reactions noted were slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.

Under the test conditions, the dermal LD50 of the test substance is >5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Justification for classification or non-classification

Self classification:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the oral and dermal LD50 are higher than 5000 mg/kg bw.